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Non-variceal upper gastrointestinal (GI) bleeding is a significant cause of morbidity and mortality. Traditionally, through-the-scope (TTS) clips, thermal therapy, and injection therapies are used to treat GI bleeding. In this review, we provide an overview of novel endoscopic treatments that can be used to achieve hemostasis. Specifically, we discuss the efficacy and applicability of over-the-scope clips, hemostatic agents, TTS doppler ultrasound, and endoscopic ultrasound, each of which offer an effective method of reducing rates of GI rebleeding.

Background: Aortoesophageal fistula (AEF) is a rare cause of upper gastrointestinal hemorrhage. Despite diagnostic and therapeutic advances, the mortality rate in AEF patients remains high because of its fulminant course, even with maximal intensive care. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a resuscitation technique to control life-threatening bleeding. It has become an important modality in the management of life-threatening, traumatic or non-traumatic, arterial bleeding. However, it's use in hemorrhagic shock caused by cancer has rarely been reported. Case presentation: A 51-year-old woman with a history of esophageal cancer presented to our emergency department with hematemesis. Computed tomography was performed because of a strong suspicion of hemorrhagic shock. With a diagnosis of AEF due to esophageal cancer, emergency thoracic endovascular aortic repair was performed while the bleeding was controlled using REBOA. Staged elective esophageal reconstruction was successfully performed. Conclusions: Hemostasis is crucial in patients who present with suspected hemorrhagic shock attributable to AEF. The timely implementation of REBOA has shown promise and potential effectiveness in such cases. [ABSTRACT FROM AUTHOR]

Background: Excessive intraoperative bleeding remains a challenge in limb surgeries. The exsanguination tourniquet ring has emerged as a potential solution for effective exsanguination and hemostasis. This study aims to evaluate its efficacy and safety compared to the conventional exsanguination and hemostasis approach (pneumatic tourniquet combined with Esmarch bandage). Methods: This randomized controlled trial evaluates the exsanguination tourniquet ring's effectiveness and safety versus the conventional approach in 220 participants undergoing various limb surgeries. Allocation included experimental and control groups, assesses through efficacy (including intraoperative and total blood loss, hemoglobin levels, and exsanguination and hemostasis effectiveness) and safety (adverse event occurrence) indicators. Results: The experimental group (n = 110) utilizes the exsanguination tourniquet ring, while the control group (n = 110) employs the conventional approach. As for intraoperative blood loss, the experimental group is non-inferior to the control group (p-value < 0.001). While no significant difference is found in total blood loss (for the full analysis set, p-value = 0.442; for the per protocol set, p-value = 0.976) and differences in postoperative and preoperative hemoglobin levels (for the full analysis set, p-value = 0.502; for the per protocol set, p-value = 0.928). Regarding exsanguination and hemostasis effectiveness, the full analysis set reveals significantly superior ratings in the experimental group compared to the control group (p-value = 0.002 < 0.05), while the per protocol set analysis indicates no significant difference between the groups (p-value = 0.504). As for safety indicators, adverse events related to the device are minimal in two groups, with only one severe event unrelated to the device. Conclusions: The exsanguination tourniquet ring is an effective and safe device for intraoperative blood loss control in various limb surgeries. Trial registration: Comparison of Exsanguination and Hemostasis Devices for Limb Surgery A Prospective Multicenter Randomized Controlled Study, ChiCTR2300077998, 11/27/2023. [ABSTRACT FROM AUTHOR]

Chitosan (CS) has been extensively studied in wound care for its intrinsic hemostatic and antibacterial properties. However, CS has limiting hemostasis applications on account of its drawbacks such as poor adhesion in humid environments and water solubility at neutral pH. CS-based biomaterials, inspired by mussel-adhesive proteins, serve as a suggested platform by biomedical science. The reports show that the mussel-inspired CS-based hemostatic structure has negligible toxicity and excellent adhesiveness. Biomedicine has witnessed significant progress in the development of these hemostatic materials. This review summarizes the methods for the modification of CS by mussel-inspired chemistry. Moreover, the general method for preparation of mussel-inspired CS-based biomaterials is briefly discussed in this review. This work is expected to give a better understanding of opportunities and challenges of the mussel-inspired strategy for the functionalization of CS-based biomaterials in hemostasis and wound healing. This review is hoped to provide an important perspective on the preparation of mussel-inspired CS-based hemostatic materials. [ABSTRACT FROM AUTHOR]

To explore preoperative and operative risk factors for red blood cell (RBC) transfusion requirements during liver transplantation (LT) and up to 24 h afterwards. We evaluated the associations between risk factors and units of RBC transfused in 176 LT patients using a log-binomial regression model. Relative risk was adjusted for age, sex, and the model for end-stage liver disease score (MELD) (adjustment 1) and baseline hemoglobin concentration (adjustment 2). Forty-six patients (26.14%) did not receive transfusion. Grafts from cardiac-death donors were used in 32.61% and 31.54% of non-transfused and transfused patients, respectively. The transfused group required more reoperation for bleeding (P = 0.035), longer mechanical ventilation after LT (P < 0.001), and longer ICU length of stay (P < 0.001). MELD and hemoglobin concentrations determined RBC requirements. For each unit of increase in the MELD score, 2% more RBC units were transfused, and non-transfusion was 0.83-fold less likely. For each 10-g/L higher hemoglobin concentration at baseline, 16% less RBC transfused, and non-transfusion was 1.95-fold more likely. Ascites was associated with 26% more RBC transfusions. With an increase of 2 mm from the baseline in the A10Fibtem measurement of maximum clot firmness, non-transfusion was 1.14-fold more likely. A 10-min longer cold ischemia time was associated with 1% more RBC units transfused, and the presence of post-reperfusion syndrome with 45% more RBC units. We conclude that preoperative correction of anemia should be included in LT. An intervention to prevent severe hypotension and fibrinolysis during graft reperfusion should be explored. Trial register: European Clinical Trials Database (EudraCT 2018–002,510-13) and ClinicalTrials.gov (NCT01539057). [ABSTRACT FROM AUTHOR]

Background/Objectives: This study evaluated the hemostatic performance and safety of ActiClot (ATC), a new flowable hemostatic agent, through in vivo tests. Methods: ATC was compared with the commercially available FLOSEAL®. ATC consists of carboxymethyl starch, thrombin, and sorbitol powders in Syringe I, and a calcium chloride solution in Syringe II. In vivo evaluation used rat liver bleeding and porcine heart bleeding models. Safety was assessed using a rat subcutaneous implantation model. Results: ATC significantly reduced hemostasis time (70.00 ± 7.35 s) compared to gauze control (240.63 ± 32.31 s) in the rat liver model, showing a 70% reduction. There was no significant difference between ATC and FLOSEAL® (58.75 ± 13.42 s). In the porcine heart model, both agents achieved 100% hemostasis within 3 min, with no significant difference in success rates within 2 min (ATC 87.5%, FLOSEAL® 75%). The gauze control group failed in all tests. The rat subcutaneous implantation model showed no visual ATC observation after 48 h, indicating biocompatibility, with no inflammation observed. Conclusions: ATC demonstrated effective hemostatic performance similar to FLOSEAL® in two in vivo models, with faster hemostasis in the rat liver model. It also showed excellent safety and biocompatibility, indicating its potential for surgical and emergency bleeding control. [ABSTRACT FROM AUTHOR]

Vascular hemostasis after venous and arterial access in cardiovascular procedures remains a challenge. As sheath size gets larger for structural heart and vascular procedures, no dedicated closure devices exist that can overcome all the challenges of achieving vascular hemostasis, in particular on the venous side. Efficiently and reliably ensuring hemostasis at the access point is crucial for enhancing the safety of a procedure. Historically, hemostasis relied on manually compressing venous access sites. However, the shift towards larger sheaths and the more frequent use of continuous anticoagulation has strained this approach. Achieving hemostasis solely through compression in these scenarios demands heightened vigilance and prolonged application, resulting in increased patient discomfort and extended immobility. Consequently, manual compression may consume more time for healthcare providers and contribute to bed occupancy in hospitals. This review article summarizes the development of the SiteSeal® Vascular Closure Device, a novel leave-nothing-behind approach to achieve hemostasis. The introduction of this technology has provided clinicians with a safer and more effective way to achieve immediate hemostasis, facilitate early ambulation, and enable earlier discharges with fewer access site complications compared with traditional manual compression. [ABSTRACT FROM AUTHOR]

Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of global mortality. Despite clinical predictors (age, severity, comorbidities, etc.) being established, proteomics offers comprehensive biological profiling to obtain deeper insights into COPD pathophysiology and survival prognoses. This pilot study aimed to identify proteomic footprints that could be potentially useful in predicting mortality in stable COPD patients. Plasma samples from 40 patients were subjected to both blind (liquid chromatography–mass spectrometry) and hypothesis-driven (multiplex immunoassays) proteomic analyses supported by artificial intelligence (AI) before a 4-year clinical follow-up. Among the 34 patients whose survival status was confirmed (mean age 69 ± 9 years, 29.5% women, FEV1 42 ± 15.3% ref.), 32% were dead in the fourth year. The analysis identified 363 proteins/peptides, with 31 showing significant differences between the survivors and non-survivors. These proteins predominantly belonged to different aspects of the immune response (12 proteins), hemostasis (9), and proinflammatory cytokines (5). The predictive modeling achieved excellent accuracy for mortality (90%) but a weaker performance for days of survival (Q2 0.18), improving mildly with AI-mediated blind selection of proteins (accuracy of 95%, Q2 of 0.52). Further stratification by protein groups highlighted the predictive value for mortality of either hemostasis or pro-inflammatory markers alone (accuracies of 95 and 89%, respectively). Therefore, stable COPD patients' proteomic footprints can effectively forecast 4-year mortality, emphasizing the role of inflammatory, immune, and cardiovascular events. Future applications may enhance the prognostic precision and guide preventive interventions. [ABSTRACT FROM AUTHOR]

Aortic stenosis (AS) is a prevalent valvular disorder that poses a significant burden on healthcare systems due to its debilitating symptoms and high mortality rates if left untreated. Surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) are the primary interventions for severe AS, but perioperative complications such as bleeding remain a concern. Von Willebrand factor (VWF), a crucial player in hemostasis, is known to be altered in AS and may contribute to the hemostatic imbalance observed in these patients. This prospective study aimed to investigate the association between prosthetic valve type, size, and postprocedural VWF levels in patients undergoing aortic valve replacement (AVR) for severe AS. This study involved 39 consecutive patients diagnosed with severe AS who underwent SAVR or TAVR. By elucidating the VWF dynamics associated with different prosthetic valves, this study sought to provide valuable insights into personalized valve selection and perioperative management strategies. [ABSTRACT FROM AUTHOR]

Reaction Systems (RSs) are a computational framework inspired by biochemical mechanisms. An RS defines a finite set of reactions over a finite set of entities (molecules, proteins, etc). Starting from an initial set of entities (the initial state), a computation is performed by applying all reactions to a state in order to produce the following state, giving rise to a sequence of sets of entities. RSs have shown to be a general computational framework whose application ranges from the modeling of biological phenomena to molecular chemistry and computer science. In this paper, we contribute to research on the application of RSs for modeling biological systems. We consider the problem of modeling hemostasis, for which several models have been defined, starting from the 1960s. Previous models are based on sets of ordinary differential equations, while we develop a discrete model in RSs for pathways of the secondary hemostasis. Then, we implement our model in BioReSolve, a computational framework for RSs that we have previously defined which provides tools for the specification and verification of properties. By using the tools in BioReSolve we derive important observations on the model behaviour for hemostasis, and in particular, we study the role of three important inhibitors, verifying that their presence or absence leads to phenomena such as thrombophilia, or thromboembolism, or excessive coagulation, etc. We can also study computationally the causality relations between the molecules involved in the reactions showing which entities play a fundamental role, thus contributing to the design of more effective and specialized drugs. Our work can hence help to show how to model complex biological systems in RSs and derive computationally and biologically relevant properties of the systems. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of an aseptic elastic repellent tourniquet in the surgical treatment of lower limb injuries in athletes, resembling those commonly seen in military training. Methods: This prospective study involved 72 athletes experiencing lower limb injuries, divided equally into an observation group and a control group. The observation group underwent surgery with the application of a blood expelling tourniquet, while the control group received a traditional pneumatic tourniquet. Metrics compared included operation preparation time, average operation duration, hemostatic effectiveness, hemoglobin levels, and incidence of postoperative complications. Results: The use of the blood expelling tourniquet significantly reduced the operation preparation time in the observation group (P < 0.05). Hemoglobin levels on the first and third days' post-operation were higher in the observation group compared to the control group (P < 0.05). Additionally, the observation group exhibited a lower incidence of skin-related complications such as skin blisters and lower extremity venous thrombosis (P < 0.05). Conclusion: The application of an aseptic elastic repellent tourniquet in surgeries for athletic lower limb injuries offers significant advantages. It not only shortens preparation and surgery times but also minimizes intraoperative bleeding and reduces the risk of postoperative complications, enhancing recovery outcomes. This study supports the use of this tourniquet type in sports medicine, particularly for injuries analogous to those encountered in rigorous training scenarios like military exercises. [ABSTRACT FROM AUTHOR]

Sea buckthorn (Hippophae rhamnoides L.) is a tree or shrub with small, orange berries. Sea buckthorn seeds have shown many properties beneficial to human health, including antioxidant, anti-hypertensive, anti-hyperlipidemic, and retinoprotective activities. Seeds, as a component of food, are often exposed to high temperatures, which can increase or decrease their biological activity. In our previous study, we showed that both raw and roasted sea buckthorn seeds had significant antioxidant activity, which was measured in human plasma in vitro. In this paper, we evaluated the effect of extracts from raw and roasted sea buckthorn seeds on several parameters of hemostasis in vitro, including thrombus formation in full blood (measured by the Total Thrombus formation Analysis System—T-TAS), blood platelet activation (based on the exposition of P-selectin, the active form of GPIIb/IIIa on their surface and platelet-derived microparticles formation), aggregation (measured with impedance aggregometry), adhesion to fibrinogen and collagen, arachidonic acid metabolism in washed platelets stimulated by thrombin, and COX-1 activity. We also measured the levels of free 8-isoprostane in plasma and the total non-enzymatic antioxidant status of plasma. The extract from roasted seeds (50 µg/mL) significantly prolonged the time of occlusion measured by T-TAS—the AUC10 (area under the curve) value was decreased by approximately 18%. Both extracts decreased the exposition of the active form of GPIIb/IIIa on the surface of platelets activated with 10 μM ADP (by 38.4–62.2%) and 20 μM ADP (by 39.7–51.3%). Moreover, the extract from raw seeds decreased the exposition of P-selectin on the surface of platelets stimulated with 20 μM ADP (by 31.2–34.9%). The adhesion of thrombin-stimulated platelets to fibrinogen and collagen was inhibited only by the extract from roasted sea buckthorn seeds (by 20–30%). Moreover, the extract from raw seeds inhibited the level of TBARS (thiobarbituric acid-reactive substances, an indicator of enzymatic peroxidation of arachidonic acid) in washed platelets stimulated with thrombin; the activity of COX-1 was inhibited by both extracts, although the effect of the extract from raw seeds was stronger. These results indicate that sea buckthorn seeds have anti-platelet activity that is not decreased by thermal processing, but more research is needed to determine which exact chemical compounds and mechanisms are responsible for this phenomenon. [ABSTRACT FROM AUTHOR]

Background: Coagulation abnormalities are common in sepsis patients and are associated with increased mortality. This study aimed to assess the hemostatic profile of sepsis patients using rotational thromboelastometry (ROTEM) and to find the ROTEM parameters best predicting short-term mortality. Methods: We conducted a prospective analysis of consecutive sepsis patients hospitalized in the intensive care unit. The inclusion criteria were diagnosis of sepsis or septic shock and pro-calcitonin concentration >0.5 ng mL−1. Clinical, standard laboratory, and ROTEM analyses were performed. Results: The study group comprised 38 (49%) males and 40 (51%) females. Median Sequential Organ Failure Assessment (SOFA) score was 8 (interquartile range IQR 5–11) points. The most common primary sites of infection were pneumonia (n = 27/35%), intra-abdominal (n = 27/35%), urinary tract infection (n=20/26%), and others (n = 4/6%). The following parameters evaluating fibrinogen function were outside the reference range: clotting time (CT), clot amplitude (A) at 10 and 20 min, and maximal clot firmness (MCF). Out of 78 patients, 28 (36%) died in the intensive care unit. Significant differences between survivors and non-survivors of sepsis were present for the ROTEM parameters assessing fibrinolytic activity. Conclusions: ROTEM in the early phase of sepsis reveals increased coagulation mediated through the function of fibrinogen. Non-survivors showed slightly lower fibrinolytic activity than survivors; however, it was still within test reference values. The highest predicting value was obtained by a model incorporating, among others, extrinsic coagulation pathway fibrinolytic parameters. [ABSTRACT FROM AUTHOR]

Platelet-derived extracellular vesicles (pEVs) are emerging as pivotal players in numerous physiological and pathological processes, extending beyond their traditional roles in hemostasis and thrombosis. As one of the most abundant vesicle types in human blood, pEVs transport a diverse array of bioactive molecules, including growth factors, cytokines, and clotting factors, facilitating crucial intercellular communication, immune regulation, and tissue healing. The unique ability of pEVs to traverse tissue barriers and their biocompatibility position them as promising candidates for targeted drug delivery and regenerative medicine applications. Recent studies have underscored their involvement in cancer progression, viral infections, wound healing, osteoarthritis, sepsis, cardiovascular diseases, rheumatoid arthritis, and atherothrombosis. For instance, pEVs promote tumor progression and metastasis, enhance tissue repair, and contribute to thrombo-inflammation in diseases such as COVID-19. Despite their potential, challenges remain, including the need for standardized isolation techniques and a comprehensive understanding of their mechanisms of action. Current research efforts are focused on leveraging pEVs for innovative anti-cancer treatments, advanced drug delivery systems, regenerative therapies, and as biomarkers for disease diagnosis and monitoring. This review highlights the necessity of overcoming technical hurdles, refining isolation methods, and establishing standardized protocols to fully unlock the therapeutic potential of pEVs. By understanding the diverse functions and applications of pEVs, we can advance their use in clinical settings, ultimately revolutionizing treatment strategies across various medical fields and improving patient outcomes. [ABSTRACT FROM AUTHOR]

Blood transfusion is a common therapeutic intervention in hospitalized patients. There are numerous indications for transfusion, including anemia and coagulopathy with deficiency of single or multiple coagulation components such as platelets or coagulation factors. Nevertheless, the practice of transfusion in critically ill patients has been controversial mainly due to a lack of evidence and the need to consider the appropriate clinical context for transfusion. Further, transfusion carries many risk factors that must be balanced with benefits. Therefore, transfusion practice in ICU patients has constantly evolved, and we endeavor to present a contemporary review of transfusion practices in this population guided by clinical trials and expert guidelines. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate post-tonsillectomy healing process using combined cold dissection and bipolar cautery for hemostasis. Methods: This case series included patients for whom tonsillectomy was done by cold dissection and limited the bipolar cautery for hemostasis and dealing with the lower pole only. Saline irrigation was used for the tonsillar bed after tonsillectomy and a wet saline-moistened pack was placed into the tonsil fossa. Intra-oral digital photographs were reviewed postoperative, at 3rd, 5th, 7th, 9th, 11th, 13th, 15th, and 21st day after surgery. Patients were asked to register their postoperative pain using a standardized visual analog scale. The time of separation of the healing membrane (HM) and any blood clot and/or bleeding surface were recorded. Results: Among included 114 patients, the HM color was white without odor in all cases. Extension of the HM was limited to the tonsillar bed in 112 patients (98%) and exceeded in 2 patients (2%). The mean time for HM separation was 8.8 ± 1.1 days (range = 7–14) with a significantly longer period of separation in females (p = 0.0008). There was no significant correlation between the time of the HM separation and the age of the patients (P = 0.9). Conclusion: Cold dissection tonsillectomy with limited hot tools usage for hemostasis by bipolar cautery with frequent saline wash leads to odorless HM and a good healing process with an average separation of the HM and so less pain and post-tonsillectomy bleeding. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to clarify the relationship between fluctuations in uterine stiffness during the third stage of labor and blood loss upon placenta delivery using shear wave elastography. Methods: This prospective cohort study enrolled consecutive singleton pregnant women above 37 weeks of gestation who delivered infants transvaginally at a single perinatal center. Shear wave velocities (SWV) were continuously measured during the third stage of transvaginal labor using transabdominal ultrasound and these values were compared between groups with large (≥500 g) and small amounts of bleeding during this stage. Results: In total, 8 cases of large bleeding and 47 cases of small bleeding were compared. The large amount of bleeding group had a significantly lower median of minimum SWV values (0.97 [0.52–1.01] m/s than the small amount of bleeding group (1.25 [1.04–1.48] m/s p = 0.02). However, no significant differences were observed between the two groups in terms of median, mean, and maximum SWV values. The time from delivery of the infant to placental delivery was significantly longer in the large amount of bleeding group (median time: 370.5 s vs. 274 s, p < 0.05). Conclusion: Ultrasound quantification of uterine stiffness using shear wave elastography demonstrated that uterine contractions may influence the biological hemostasis of the uterus during the third stage of labor. Baseline uterine stiffness was weak and a longer duration of placental separation might be associated with cases of large amounts of bleeding during this stage. [ABSTRACT FROM AUTHOR]

Rapid and safe hemostasis is crucial for the survival of bleeding patients in prehospital care. It is urgent to develop high performance hemostatic material to control the massive hemorrhage in the military field and accidental trauma. In this work, an efficient protein hemostat of thrombin was immobilized onto commercial gauze, which was mediated by self-polymerization and anchoring of tannic acid (TA). Through TA treatment, the efficient immobilization of thrombin was achieved, preserving both the biological activity of thrombin and the physical properties of the dressing, including absorbency, breathability, and mechanical performance. Moreover, in the presence of TA coating and thrombin, Gau@TA/Thr could obviously shortened clotting time and enriched blood components such as plasma proteins, platelets, and red blood cells, thereby exhibiting an enhanced in vitro coagulation effect. In SD rat liver volume defect and artery transection hemorrhage models, Gau@TA/Thr still had outstanding hemostatic performance. Besides, the Gau@TA/Thr gauze had inherent antibacterial property and demonstrated excellent biocompatibility. All results suggested that Gau@TA/Thr would be a potential candidate for treating uncontrollable hemorrhage in prehospital care. [ABSTRACT FROM AUTHOR]

With the aging of the population, the proportion of patients receiving long-term antiplatelet therapy among those undergoing surgical treatment is increasing. Potential platelet hypofunction caused by antiplatelet drugs can affect intraoperative hemostasis and increase the risks of massive intraoperative hemorrhage and postoperative bleeding complications. Therefore, a quick and accurate assessment of platelet function before surgery is of great significance in comprehensively evaluating a patient’s hemostatic function. Based on the summary of relevant literature and the current status of the application of platelet function tests in neurosurgery, this paper analyzed the advantages and disadvantages of the currently commonly used platelet function tests, and introduced relevant therapies to improve platelet function, with the aim of improving the understanding of platelet function among neurosurgeons. [ABSTRACT FROM AUTHOR]

Background/Aims: Gastrointestinal bleeding is a significant and potentially lethal event. We aimed to review the efficiency and safety of self-assembling peptides for the treatment and prevention of gastrointestinal tract bleeding. Methods: We conducted a systematic search for studies describing the endoscopic use of self-assembling peptides for treatment or prevention of bleeding in the gastrointestinal tract in a parallel, independent fashion. The primary outcomes were rates of successful initial hemostasis, delayed bleeding, and rebleeding. The secondary outcomes were adverse events and ease and volume of gel used. Results: Seventeen studies were analyzed. Overall success rate of self-assembling peptides in gastrointestinal bleeding was 87.7% (38%- 100%), regardless of etiology or associated treatments. Rebleeding rate ranged from 0% to 16.2%, with a mean of 4.7%, and overall delayed bleeding rate was 5% (range, 0%-15.9%). Only three adverse events were reported in a pooled number of 815 patients. The volume of gel used varied (0.43 to 3.7 mL) according to indication and type of bleeding. Conclusions: The limited available data on the use of self-assembling peptides in gastrointestinal endoscopy suggest a high efficiency and good safety profile. [ABSTRACT FROM AUTHOR]

Background Hemostatic powders are used as second-line treatment in acute gastrointestinal (GI) bleeding (AGIB). Increasing evidence supports the use of TC-325 as monotherapy in specific scenarios. This prospective, multicenter study evaluated the performance of TC-325 as monotherapy for AGIB. Methods Eighteen centers across Europe and USA contributed to a registry between 2016 and 2022. Adults with AGIB were eligible, unless TC-325 was part of combined hemostasis. The primary endpoint was immediate hemostasis. Secondary outcomes were rebleeding and mortality. Associations with risk factors were investigated (statistical significance at P=0.05). Results One hundred ninety patients were included (age 51-81 years, male: female 2:1), with peptic ulcer (n=48), upper GI malignancy (n=79), post-endoscopic treatment hemorrhage (n=37), and lower GI lesions (n=26). The primary outcome was recorded in 96.3% (95% confidence interval [CI]: 92.6-98.5) with rebleeding in 17.4% (95%CI 11.9-24.1); 9.9% (95%CI 5.8-15.6) died within 7 days, and 21.7% (95%CI 15.6-28.9) within 30 days. Regarding peptic ulcer, immediate hemostasis was achieved in 88% (95%CI 75-95), while 26% (95%CI 13-43) rebled. Higher ASA score was associated with mortality (OR 23.5, 95%CI 1.60-345; P=0.02). Immediate hemostasis was achieved in 100% of cases with malignancy and post-intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received TC-325 for lower GI bleeding, and in all but one the primary outcome was achieved. Conclusions TC-325 monotherapy is safe and effective, especially in malignancy or postendoscopic intervention bleeding. In patients with peptic ulcer, it could be helpful when the primary treatment is unfeasible, as bridge to definite therapy. [ABSTRACT FROM AUTHOR]

This study was conducted to investigate the effects of 12 weeks of aerobic exercise (AT) and saffron supplementation on hemostasis, inflammatory markers, and insulin resistance in obese women diagnosed with type 2 diabetes (T2D). A total of 44 women with T2D (mean age: 54.12 ± 5.63 years, mean BMI: 31.15 ± 1.50 kg/m2, HbA1c: 85 ± 4.2 mmol/mol) were included in a randomized, double‐blind, placebo‐controlled study. We were randomly assigned to one of four groups (n = 11 per group): saffron + training (ST), placebo + training (PT), saffron supplement (SS), and placebo (P). The ST and PT groups completed 12 weeks of AT (three sessions per week of mild to moderate intensity). The ST and SS groups were administered a daily dose of 200 mg of saffron powder for 12 weeks. Fasting blood samples were collected 48 h before the first AT session and/or nutritional supplementation and 48 h after the last AT session and/or nutritional supplementation. Post‐evaluation, homeostatic model assessment of insulin resistance value (HOMA‐IR, p < 0.001) and serum levels of glucose (p < 0.001), fibrinogen (FIB, p < 0.001), homocysteine (HCY, p < 0.001), interleukin‐6 (IL‐6, p < 0.001), and tumor necrosis factor α (TNFα, p < 0.001) showed significant reduction in the ST, PT, and SS groups compared to the P group (p < 0.05). In particular, the ST group showed a more significant reduction in all variables compared to the PT and SS groups (p < 0.05). Our results suggest that a 12‐week intervention with AT and saffron supplementation can independently improve markers related to hemostasis, inflammation, and insulin resistance. However, their combination showed the greatest effectiveness on the above markers. Highlights: Type 2 diabetes can disturb hemostasis and induce inflammation.12 weeks of aerobic training (AT) and saffron supplementation can independently improve hemostasis, inflammation, and insulin resistance.The combination of 12 weeks of AT and saffron supplementation showed the greatest effectiveness on hemostasis, inflammation, and insulin resistance. [ABSTRACT FROM AUTHOR]

Managing hemophilia in patients undergoing joint replacement surgery requires a comprehensive approach encompassing preoperative assessment, meticulous intraoperative care, and tailored postoperative management. Evaluation of joint integrity, bleeding history, and inhibitor presence guides surgical planning and hemostatic therapy selection to optimize outcomes. During surgery, careful attention to factor replacement, antibiotic prophylaxis, anesthetic techniques, and orthopedic strategies minimizes bleeding risk and enhances surgical success. Postoperatively, effective pain management, continued hemostatic therapy, and individualized rehabilitation programs are vital for facilitating recovery and preventing complications. Close monitoring for potential complications, such as periprosthetic joint infection and recurrent hemarthrosis, allows for prompt intervention when necessary. Overall, a collaborative approach involving hematologists, orthopedic surgeons, anesthesiologists, and rehabilitation specialists ensures comprehensive care tailored to the unique needs of patients with hemophilia undergoing joint replacement surgery, ultimately optimizing outcomes and improving quality of life. This holistic approach addresses the multifaceted challenges posed by hemophilia and joint replacement surgery, providing patients with the best possible chance for successful outcomes and long-term joint function. By integrating specialized expertise from multiple disciplines and implementing evidence-based strategies, healthcare providers can effectively manage hemophilia in the context of joint replacement surgery, mitigating risks and maximizing benefits for patients. [ABSTRACT FROM AUTHOR]

Immune thrombocytopenia (ITP) is the most common acquired primary hemostatic disorder in dogs. Immune thrombocytopenia less commonly affects cats but is an important cause of mortality and treatment‐associated morbidity in both species. Immune thrombocytopenia remains a diagnosis of exclusion for which diagnostic guidelines are lacking. Primary, or non‐associative, ITP refers to autoimmune platelet destruction. Secondary, or associative, ITP arises in response to an underlying disease trigger. However, evidence for which comorbidities serve as ITP triggers has not been systematically evaluated. To identify key diagnostic steps for ITP and important comorbidities associated with secondary ITP, we developed 12 Population Evaluation/Exposure Comparison Outcome (PECO) format questions. These questions were addressed by evidence evaluators utilizing a literature pool of 287 articles identified by the panelists using a structured search strategy. Evidence evaluators, using panel‐designed templates and data extraction tools, summarized evidence and created guideline recommendations that then were integrated by diagnosis and comorbidity domain chairs. The revised PECO responses underwent a Delphi survey process to reach consensus on final guidelines. A combination of panel expertise and PECO responses were employed to develop algorithms for diagnosis of ITP in dogs and cats, which also underwent 4 iterations of Delphi review. Comorbidity evidence evaluators employed an integrated measure of evidence (IME) tool to determine evidence quality for each comorbidity; IME values combined with evidence summaries for each comorbidity were integrated to develop ITP screening recommendations, which also were subjected to Delphi review. Commentary was solicited from multiple relevant professional organizations before finalizing the consensus. The final consensus statement provides clinical guidelines for the diagnosis of, and underlying disease screening for, ITP in dogs and cats. The systematic consensus process identified numerous knowledge gaps that should guide future studies. This statement is a companion manuscript to the ACVIM Consensus Statement on the Treatment of Immune Thrombocytopenia. [ABSTRACT FROM AUTHOR]

Nanoparticles (NP) play a crucial role in nanomedicine, serving as carriers for localized therapeutics to allow for precise drug delivery to specific disease sites and conditions. When injected systemically, NP can directly interact with various blood cell types, most critically with circulating platelets. Hence, the potential activation/inhibition of platelets following NP exposure must be evaluated a priori due to possible debilitating outcomes. In recent years, various studies have helped resolve the physicochemical parameters that influence platelet‐NP interactions, and either emphasize nanoparticles' therapeutic role such as to augment hemostasis or to inhibit thrombus formation, or conversely map their potential undesired side effects upon injection. In the present review, we discuss some of the main effects of several key NP types including polymeric, ceramic, silica, dendrimers and metallic NPs on platelets, with a focus on the physicochemical parameters that can dictate these effects and modulate the therapeutic potential of the NP. Despite the scientific and clinical significance of understanding Platelet‐NP interactions, there is a significant knowledge gap in the field and a critical need for further investigation. Moreover, improved guidelines and research methodologies need to be developed and implemented. Our outlook includes the use of biomimetic in vitro models to investigate these complex interactions under both healthy physiological and disease conditions. [ABSTRACT FROM AUTHOR]

Background: This study investigated perioperative clinical information, surgical findings, and postoperative courses of patients who underwent reoperation due to bleeding after the surgery for pulmonary malignancies. Methods: We identified patients who underwent reoperation due to postoperative bleeding from 6989 patients who had had operations for pulmonary malignancies between January 2007 and July 2019. Data were retrospectively collected from medical charts. Results: Twenty-two patients (0.3%) underwent reoperation for hemostasis. The reason for reoperation was a shock state with minimum systolic blood pressure < 90 mm Hg in 12 patients (55%), persistent bloody drainage of 100 mL/h or more in 15 patients (68%), and intrathoracic hematoma on a chest X-ray image in 14 patients (64%). All those three findings were observed in five patients (23%), two in nine patients (41%), and one in eight patients (36%). The source of bleeding could not be identified during reoperation in four patients (18%). In the regression analysis, the coefficient of determination between the amount of drainage from a chest drain and the volume of intrathoracic hematoma found during reoperation was 0.31, indicating poor correlation. Postoperative complications and death occurred in two (9%) and zero patients, respectively. Conclusion: Reoperation due to bleeding is required in certain cases. The amount of drainage from a chest drain does not necessarily reflect the volume of intrathoracic hematoma and it is hard to estimate the total amount of bleeding. The decision to perform reoperation for hemostasis should be comprehensively made on the basis of clinical signs and chest X-ray findings. [ABSTRACT FROM AUTHOR]

This paper presents results from the development of a disposable piezoelectric sensor and a cartridge based on it for a portable device for rapid assessment of the functional state of the hemostasis system based on analysis of native capillary blood. The design of a disposable piezoelectric sensor and the resonant frequency for studies of the human blood coagulation system were selected. Results obtained from tests of the method and device using normal plasma and native capillary blood showed that results were reproducible, indicating that there is promise in employing acoustic effects to study the properties of blood and to develop portable devices based on them for operation in the "point-of-care" mode. Analyte volume is 20–25 µl, which makes the device convenient for use outside medical institutions. [ABSTRACT FROM AUTHOR]

Natural and synthetic colorants present in food can modulate hemostasis, which includes the coagulation process and blood platelet activation. Some colorants have cardioprotective activity as well. However, the effect of genipin (a natural blue colorant) and synthetic blue colorants (including patent blue V and brilliant blue FCF) on hemostasis is not clear. In this study, we aimed to investigate the effects of three blue colorants—genipin, patent blue V, and brilliant blue FCF—on selected parameters of hemostasis in vitro. The anti- or pro-coagulant potential was assessed in human plasma by measuring the following coagulation times: thrombin time (TT), prothrombin time (PT), and activated partial thromboplastin time (APTT). Moreover, we used the Total Thrombus formation Analysis System (T-TAS, PL-chip) to evaluate the anti-platelet potential of the colorants in whole blood. We also measured their effect on the adhesion of washed blood platelets to fibrinogen and collagen. Lastly, the cytotoxicity of the colorants against blood platelets was assessed based on the activity of extracellular lactate dehydrogenase (LDH). We observed that genipin (at all concentrations (1–200 µM)) did not have a significant effect on the coagulation times (PT, APTT, and TT). However, genipin at the highest concentration (200 µM) and patent blue V at the concentrations of 1 and 10 µM significantly prolonged the time of occlusion measured using the T-TAS, which demonstrated their anti-platelet activity. We also observed that genipin decreased the adhesion of platelets to fibrinogen and collagen. Only patent blue V and brilliant blue FCF significantly shortened the APTT (at the concentration of 10 µM) and TT (at concentrations of 1 and 10 µM), demonstrating pro-coagulant activity. These synthetic blue colorants also modulated the process of human blood platelet adhesion, stimulating the adhesion to fibrinogen and inhibiting the adhesion to collagen. The results demonstrate that genipin is not toxic. In addition, because of its ability to reduce blood platelet activation, genipin holds promise as a novel and valuable agent that improves the health of the cardiovascular system and reduces the risk of cardiovascular diseases. However, the mechanism of its anti-platelet activity remains unclear and requires further studies. Its in vivo activity and interaction with various anti-coagulant and anti-thrombotic drugs, including aspirin and its derivatives, should be examined as well. [ABSTRACT FROM AUTHOR]

Background: Perinatal hypoxia may result in coagulation dysfunction. Diminished blood flow or oxygen to the fetus/neonate during the perinatal period can cause bone marrow and liver function impairment, leading to thrombocytopenia, impaired synthesis of clotting and fibrinolytic factors, and increased destruction of platelets in the small blood vessels. The goal of the present study was to evaluate the hemostatic status of newborns with perinatal hypoxia via the non-activated thromboelastometry (NATEM) assay in cord blood samples. Methods: 134 hypoxic neonates born in our maternity unit over a 1.5-year period were enrolled in this observational cohort study, and 189 healthy neonates served as the control group. Participation in the study was voluntary and parents signed informed consent prior to recruitment. Demographic and clinical data were recorded on admission, and the NATEM method was performed on cord blood samples. The following NATEM values were evaluated: clotting time (CT), alpha angle (α-angle), clot formation time (CFT), clot amplitude at 5 and 10 min. (A5, A10), maximum clot firmness (MCF), clot lysis index at 60 min. after CT (LI60), and maximum clot elasticity (MCE). Statistical analysis was conducted utilizing the SAS for Windows 9.4 software platform. Results: Neonates with perinatal hypoxia exhibited decreased fibrinolytic potential in comparison to healthy neonates, as indicated by increased LI60, and this difference was statistically significant (LΙ60: 94 (92–96) Vs 93 (91–95), p value = 0.0001). There were no statistically significant differences noted among the remaining NATEM variables. Conclusion: Our findings indicate decreased fibrinolytic potential in hypoxic neonates in comparison to healthy neonates, suggesting that NATEM could serve as an effective tool for promptly identifying hemostasis dysfunction in this group of neonates. [ABSTRACT FROM AUTHOR]

Aims: During intraoperative bleeding in endoscopic submucosal dissection (ESD), switching to spray coagulation may be beneficial compared with the continuous use of swift coagulation and can reduce the need for hemostatic forceps. We retrospectively assessed the effectiveness of spray modes on intraoperative bleeding during gastric ESD. Methods and Results: A total of 316 bleeding events (156 in the Swift group and 160 in the Spray group) were consecutively recorded. In the Swift group, hemostasis was performed using the swift mode with a retracted tip of the needle‐type knife, followed by the hemostatic forceps. In the Spray group, bleeding was treated in a stepwise manner: the swift mode, the spray mode, and the hemostatic forceps. All bleeding events were assigned to one of two groups by an endoscopist who retrospectively reviewed the videos. We compared the use of hemostatic forceps, the total hemostatic time, and the cumulative hemostasis rate between the two groups. The use of hemostatic forceps was significantly lower in the Spray group than in the Swift group (32.7% vs. 13.8%, P < 0.001). There was no significant difference in the total hemostatic time (Swift group, 20 s.; Spray group, 16 s.; P = 0.42), whereas the cumulative hemostasis rate with the knife was significantly higher in the Spray group (P = 0.007). Conclusion: The results suggested that spray coagulation from the tip of the needle‐type knife could reduce the use of hemostatic forceps. In gastric ESD, spray coagulation may facilitate the hemostasis of intraoperative bleeding. [ABSTRACT FROM AUTHOR]

Abstract Background Excessive intraoperative bleeding remains a challenge in limb surgeries. The exsanguination tourniquet ring has emerged as a potential solution for effective exsanguination and hemostasis. This study aims to evaluate its efficacy and safety compared to the conventional exsanguination and hemostasis approach (pneumatic tourniquet combined with Esmarch bandage). Methods This randomized controlled trial evaluates the exsanguination tourniquet ring’s effectiveness and safety versus the conventional approach in 220 participants undergoing various limb surgeries. Allocation included experimental and control groups, assesses through efficacy (including intraoperative and total blood loss, hemoglobin levels, and exsanguination and hemostasis effectiveness) and safety (adverse event occurrence) indicators. Results The experimental group (n = 110) utilizes the exsanguination tourniquet ring, while the control group (n = 110) employs the conventional approach. As for intraoperative blood loss, the experimental group is non-inferior to the control group (p-value

Abstract To explore preoperative and operative risk factors for red blood cell (RBC) transfusion requirements during liver transplantation (LT) and up to 24 h afterwards. We evaluated the associations between risk factors and units of RBC transfused in 176 LT patients using a log-binomial regression model. Relative risk was adjusted for age, sex, and the model for end-stage liver disease score (MELD) (adjustment 1) and baseline hemoglobin concentration (adjustment 2). Forty-six patients (26.14%) did not receive transfusion. Grafts from cardiac-death donors were used in 32.61% and 31.54% of non-transfused and transfused patients, respectively. The transfused group required more reoperation for bleeding (P = 0.035), longer mechanical ventilation after LT (P

Abstract Immune thrombocytopenia (ITP) is the most common acquired primary hemostatic disorder in dogs. Immune thrombocytopenia less commonly affects cats but is an important cause of mortality and treatment‐associated morbidity in both species. Immune thrombocytopenia remains a diagnosis of exclusion for which diagnostic guidelines are lacking. Primary, or non‐associative, ITP refers to autoimmune platelet destruction. Secondary, or associative, ITP arises in response to an underlying disease trigger. However, evidence for which comorbidities serve as ITP triggers has not been systematically evaluated. To identify key diagnostic steps for ITP and important comorbidities associated with secondary ITP, we developed 12 Population Evaluation/Exposure Comparison Outcome (PECO) format questions. These questions were addressed by evidence evaluators utilizing a literature pool of 287 articles identified by the panelists using a structured search strategy. Evidence evaluators, using panel‐designed templates and data extraction tools, summarized evidence and created guideline recommendations that then were integrated by diagnosis and comorbidity domain chairs. The revised PECO responses underwent a Delphi survey process to reach consensus on final guidelines. A combination of panel expertise and PECO responses were employed to develop algorithms for diagnosis of ITP in dogs and cats, which also underwent 4 iterations of Delphi review. Comorbidity evidence evaluators employed an integrated measure of evidence (IME) tool to determine evidence quality for each comorbidity; IME values combined with evidence summaries for each comorbidity were integrated to develop ITP screening recommendations, which also were subjected to Delphi review. Commentary was solicited from multiple relevant professional organizations before finalizing the consensus. The final consensus statement provides clinical guidelines for the diagnosis of, and underlying disease screening for, ITP in dogs and cats. The systematic consensus process identified numerous knowledge gaps that should guide future studies. This statement is a companion manuscript to the ACVIM Consensus Statement on the Treatment of Immune Thrombocytopenia.

Abstract Rapid and safe hemostasis is crucial for the survival of bleeding patients in prehospital care. It is urgent to develop high performance hemostatic material to control the massive hemorrhage in the military field and accidental trauma. In this work, an efficient protein hemostat of thrombin was immobilized onto commercial gauze, which was mediated by self-polymerization and anchoring of tannic acid (TA). Through TA treatment, the efficient immobilization of thrombin was achieved, preserving both the biological activity of thrombin and the physical properties of the dressing, including absorbency, breathability, and mechanical performance. Moreover, in the presence of TA coating and thrombin, Gau@TA/Thr could obviously shortened clotting time and enriched blood components such as plasma proteins, platelets, and red blood cells, thereby exhibiting an enhanced in vitro coagulation effect. In SD rat liver volume defect and artery transection hemorrhage models, Gau@TA/Thr still had outstanding hemostatic performance. Besides, the Gau@TA/Thr gauze had inherent antibacterial property and demonstrated excellent biocompatibility. All results suggested that Gau@TA/Thr would be a potential candidate for treating uncontrollable hemorrhage in prehospital care.

Worldwide, burns are the fourth most frequent type of injury. The treatment of burn wounds requires a lot of experience and an interdisciplinary approach including both surgical treatment and pharmacological wound care. The most common management of burn wounds is debridement and wound closure through the use of skin grafts. The purpose of the study was to evaluate the hemostatic and antibacterial effects of the commercially available Tromboguard® foam dressing with an active layer containing alginates and chitosan. The site of application of the product was the donor fields for skin grafts. Findings proved that a polyurethane foam dressing with an active chitosan-alginate layer is a useful option for achieving rapid hemostasis, antimicrobial protection and effective healing at split-thickness skin graft donor sites. Substances present in the active layer promote clot formation and the wound healing process.

AbstractFabrication of haemostatic materials with excellent antimicrobial, biocompatible and biodegradable properties remains as a major challenge in the field of medicine. Haemostatic agents play vital role in protecting patients and military individuals during emergency situations. Natural polymers serve as promising materials for fabricating haemostatic compounds due to their efficacy in promoting hemostasis and wound healing. In the present work, sodium alginate/aloe vera/sericin (SA/AV/S) scaffold has been fabricated using a simple cost-effective casting method. The prepared SA/AV/S scaffolds were characterised for their physicochemical properties such as scanning electron microscope, UV–visible spectroscopy and Fourier transform infra-red spectroscopy. SA/AV/S scaffold showed good mechanical strength, swelling behaviour and antibacterial activity. In vitro experiments using erythrocytes proved the hemocompatible and biocompatible features of SA/AV/S scaffold. In vitro blood clotting assay performed using human blood demonstrated the haemostatic and blood absorption properties of SA/AV/S scaffold. Scratch wound assay was performed to study the wound healing efficacy of prepared scaffolds. Chick embryo chorioallantoic membrane assay carried out using fertilised embryos proved the angiogenic property of SA/AV/S scaffold. Thus, SA/AV/S scaffold could serve as a potential haemostatic healthcare product due to its outstanding haemostatic, antimicrobial, hemocompatible, biocompatible and angiogenic properties.

Wounds, characterized by the disruption of the continuity of body tissues resulting from external trauma, manifest in diverse types and locations. Although numerous wound dressings are available for various wound scenarios, it remains challenging to find an integrative wound dressing capable of addressing diverse wound situations. We focused on utilizing sulfated hyaluronan (sHA), known for its anti-inflammatory properties and capacity to load cationic drugs. By conjugating catechol groups to sHA (sHA-CA), we achieved several advantages in wound healing: 1) Fabrication of patches through crosslinking with catechol-modified high-molecular-weight hyaluronan (HA(HMW)-CA), 2) Adhesiveness that enabled stable localization, 3) Radical scavenging that could synergize with the immunomodulation of sHA. The sHA-CA patches demonstrated therapeutic efficacy in three distinct murine wound models: diabetic wound, hepatic hemorrhage, and post-surgical adhesion. Collectively, these findings underscore the potential of the sHA-CA patch as a promising candidate for the next-generation wound dressing.

[Display omitted] Multifunctional bioactive biomaterials with integrated bone and soft tissue regenerability hold great promise for the regeneration of trauma-affected skin and bone defects. The aim of this research was to fabricate aerogel scaffolds (GD-BF) by blending the appropriate proportions of short bioactive glass fiber (BGF), gelatin (Gel), and dopamine (DA). Electrospun polyvinyl pyrrolidone (PVP)-BGF fibers were converted into short BGF through calcination and homogenization. Microporous GD-BF scaffolds displayed good elastic deformation recovery and promoted neo-tissue formation. The DA could enable thermal crosslinking and enhance the mechanical properties and structural stability of the GD-BF scaffolds. The BGF-mediated release of therapeutic ions shorten hemostatic time (<30 s) in a rat tail amputation model and a rabbit artery injury model alongside inducing the regeneration of skin appendages (e.g., blood vessels, glands, etc.) in a full-thickness excisional defect model in rats (percentage wound closure: GD-BF2, 98 % vs. control group, 83 %) at day 14 in vitro. Taken together, these aerogel scaffolds may have significant promise for soft and hard tissue repair, which may also be worthy for the other related disciplines. [ABSTRACT FROM AUTHOR]

Abstract Background Platelets stored at 1–6 °C are hypothesized to be more hemostatically active than standard room temperature platelets (RTP) stored at 20–24 °C. Recent studies suggest converting RTP to cold-stored platelets (Delayed Cold-Stored Platelets, DCSP) may be an important way of extending platelet lifespan and increasing platelet supply while also activating and priming platelets for the treatment of acute bleeding. However, there is little clinical trial data supporting the efficacy and safety of DCSP compared to standard RTP. Methods This protocol details the design of a multicentre, two-arm, parallel-group, randomized, active-control, blinded, internal pilot trial to be conducted at two cardiac surgery centers in Canada. The study will randomize 50 adult (≥ 18 years old) patients undergoing at least moderately complex cardiac surgery with cardiopulmonary bypass and requiring platelet transfusion to receive either RTP as per standard of care (control group) or DCSP (intervention group). Patients randomized to the intervention group will receive ABO-identical, buffy-coat, pathogen-reduced, platelets in platelet additive solution maintained at 22 °C for up to 4 days then placed at 4 °C for a minimum of 24 h, with expiration at 14 days after collection. The duration of the intervention is from the termination of cardiopulmonary bypass to 24 h after, with a maximum of two doses of DCSP. Thereafter, all patients will receive RTP. The aim of this pilot is to assess the feasibility of a future RCT comparing the hemostatic effectiveness of DCSP to RTP (defined as the total number of allogeneic blood products transfused within 24 h after CPB) as well as safety. Specifically, the feasibility objectives of this pilot study are to determine (1) recruitment of ≥ 15% eligible patients per center per month); (2) appropriate platelet product available for ≥ 90% of patients randomized to the cold-stored platelet group; (3) Adherence to randomization assignment (> 90% of patients administered assigned product). Discussion DCSP represents a promising logistical solution to address platelet supply shortages and a potentially more efficacious option for the management of active bleeding. No prospective clinical studies on this topic have been conducted. This proposed internal pilot study will assess the feasibility of a larger definitive study. Trial registration NCT 06147531 (clinicaltrials.gov).