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Thrombosomes are trehalose-stabilized, freeze-dried group O platelets with a 3-year shelf life. They can be stockpiled, rapidly reconstituted, and infused regardless of the recipient's blood type. Thrombosomes thus represent a potential alternative platelet transfusion strategy. The present study assessed the safety and potential early signals of efficacy of Thrombosomes in bleeding thrombocytopenic patients. We performed an open-label, phase 1 study of single doses of allogeneic Thrombosomes at three dose levels in three cohorts, each consisting of eight patients who had hematologic malignancies, thrombocytopenia, and bleeding. Adverse events, dose-limiting toxicities (DLTs), World Health Organization (WHO) bleeding scores, and hematology values were assessed. No DLTs were reported. The median age was 59 years (24-71). Most patients had AML (58%) or ALL (29%), followed by MDS (8%) and myeloproliferative neoplasm (4%). The WHO scores of 22 patients who were actively bleeding at a total of 27 sites at baseline either improved (n = 17 [63%]) or stabilized (n = 10 [37%]) through day 6. Twenty-four hours after infusion, 12 patients (50%) had a clinically significant platelet count increase. Of eight patients who received no platelet transfusions for 6 days after Thrombosomes infusion, 5 had a clinically significant increase in platelet count of ≥5000 platelets/μL and 2 had platelet count normalization. Thrombosomes doses up to 3.78 × 10 8 particles/kg demonstrated safety in 24 bleeding, thrombocytopenic patients with hematological malignancies. Thrombosomes may represent an alternative to conventional platelets to treat bleeding. A phase 2 clinical trial in a similar patient population is underway., (© 2021 Wiley Periodicals LLC.)

Civilian and military guidelines recommend balanced transfusion to patients with life-threatening bleeding. Early start of transfusion has shown improved survival. Thus, a balanced blood inventory must be available in all levels of health care to ensure early stabilization and damage control resuscitation of patients with bleeding. Whole blood has been reintroduced as a blood product for massive bleeding situations because it affords plasma, red blood cells, and platelets in a balanced ratio in a logistically advantageous way. In this article, we describe how to establish a whole blood-based blood preparedness program in a small rural hospital with limited resources. We present an implementation tool kit, which includes discussions on whole blood program strategies and the process of developing detailed procedures on donor selection, collection, storage, and transfusion management of whole blood. The importance of training and audit of the routines is highlighted, and establishment of an emergency walking blood bank is discussed. We conclude that implementation of a whole blood program is achievable in small rural hospitals and recommend that rural health care facilities at all treatment levels enable early balanced transfusion for patients with life-threatening bleeding by establishing protocols for whole blood-based preparedness., (© 2020 The Authors. Transfusion published by Wiley Periodicals LLC. on behalf of AABB.)

Thromboelastography (TEG) has been part of the assessment of patients receiving massive transfusion (MT) at Haukeland university hospital (HUH) since 2007. However, the test has been used inconsistently, and in general, the value of the test in evaluation of patients with critical bleeding is still debated, although it has been suggested that the TEG-guided treatment decreases blood usage. This single-centre retrospective study examines the use of TEG and discusses its place as part of assessing MT patients. The study focuses on the amount of blood product transfused in TEG-tested and non-TEG tested patients and whether TEG assisted coagulation therapy has affected mortality compared to conventional coagulation tests (CCTs). The study is based on the data from the massive transfusion study (MTS) 2002-15. 241 MT patients were identified, and they were grouped into patients assessed with TEG and patients who did not get this evaluation. In a sub-analysis, the patients with the initially (first TEG-test) 30 best and 30 worst TEG curves were defined based on normal ranges for the parameters R-time, α-angle, Maximal Amplitude (MA) and lysis after 30 min (LY). Survival rate and blood product usage were compared between these groups and between TEG and non-TEG patients. 111 patients were tested with TEG and 130 were not. The patients with highly pathological TEG curves (worst) have significantly higher mortality than the 30 normal-TEG patients (best) after 24 h (p < 0.001), 5 days (p < 0.05) and 30 days (p < 0.05). The best group had significantly lower mortality than the non TEG-group (p < 0.001). The difference in mortality between TEG and non-TEG patients overall was not statistically significant (p = 0.679). The TEG patients received more blood transfusions than non-TEG patients, (p < 0.001) and the patients with the worst TEG curves received the highest number of blood components. The use of TEG is debated in patients with critical bleeding. This study shows that TEG-testing is variably used in the assessment of massively bleeding patients at Haukeland University Hospital. 43.2% of 241 patients receiving massive transfusion packs were tested by TEG. When we compared the patients with the 30 best TEG curves with the 30 worst curves, there was a significantly better survival in the "best" group - without any significant difference in blood component usage. This study was not designed to provide causal information, but despite the limitations, the study indicates that the role of TEG in this patient group should be further evaluated., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objectives: To describe the change in massive transfusion (MT) practice in a single Norwegian centre throughout the period 2002-2015., Background: MT support for traumatic haemorrhage has changed since the mid-2000s. However, life-threatening haemorrhage may occur in other clinical specialties. In 2007, Haukeland University Hospital (HUS) introduced a universal MT programme including education, Acute Transfusion Packages (ATPs) and thromboelastography., Methods/materials: A retrospective review was performed of all MT episodes defined as ≥10 red cell concentrates (RCC) in 24 h. Episodes were identified using the laboratory information system. Patient records were reviewed manually for demographics, transfusion indication, haemostatic drugs and mortality. The ATPs contained six units RCC, six units Octaplas and two platelet concentrates (four buffy coats/apheresis in platelet additive solution (PAS))., Results: A total of 410 episodes were identified in 410 patients. The mean patient age was 60 years (9-94), with a male predominance (64%); 87·1% of MT episodes were in support of surgery (cardiac services 42·7%; trauma 17·6%), and 29·8% of MTs involved platelet inhibitors, with 82·6% of these undergoing cardiac procedures. MT accounted for 2·8% of all RCCs and 3·4% of platelets issued. The mean ratio of blood components RCC: plasma: platelets changed from 1·0 : 0·37 : 0·39 in 2002-2006 (n = 149) to 1·0 : 0·79 : 0·85 in 2008-2015 (n = 241, P < 0·001). A sub-analysis showed that cardiac specialities used proportionally more plasma and platelets., Conclusion: The MT programme changed transfusion practice, resulting in greater use of plasma and platelets. MT was primarily used in major surgery. The practice in cardiac surgery may reflect changes in antiplatelet medication., (© 2018 British Blood Transfusion Society.)

Background and Objectives: Platelet count is used as a prophylactic platelet transfusion trigger, although evidence suggests that it is a poor predictor of bleeding. Thus, alternative tests are required. The primary objective of this study was to compare thromboelastography (TEG) parameters on days with and without bleeding symptoms. The secondary objectives were to investigate the relationship between TEG parameters and haematological variables, fever, C-reactive protein (CRP) and platelet transfusion., Materials and Methods: This is a prospective, observational pilot study of 13 thrombocytopenic, haemato-oncologic patients, over 17 cycles of chemotherapy. Bleeding assessment was performed daily together with a total platelet count (TPC), reticulated platelet per cent (RPP) and count (RPC), haemoglobin, mean platelet volume, white blood cell count (WBC), CRP and temperature. TEG analyses were performed on weekdays., Results: TEG alpha angle was significantly lower on days with World Health Organization (WHO) grade 2 bleeding than on days without bleeding. Haematologic variables, CRP and platelet transfusion the previous day were associated with the outcome of TEG analysis, but fever was not., Conclusion: We found a highly significant correlation between the TEG alpha angle and WHO grade 2 bleeding. This finding suggests that fibrinogen-platelet interactions may affect the bleeding risk in thrombocytopenic patients., (© 2017 International Society of Blood Transfusion.)

Recent combat experience reignited interest in transfusing whole blood (WB) for patients with life-threatening bleeding. US Army data indicate that WB transfusion is associated with improved or comparable survival compared to resuscitation with blood components. These data complement randomized controlled trials that indicate that platelet (PLT)-containing blood products stored at 4°C have superior hemostatic function, based on reduced bleeding and improved functional measures of hemostasis, compared to PLT-containing blood products at 22°C. WB is rarely available in civilian hospitals and as a result is rarely transfused for patients with hemorrhagic shock. Recent developments suggest that impediments to WB availability can be overcome, specifically the misconceptions that WB must be ABO specific, that WB cannot be leukoreduced and maintain PLTs, and finally that cold storage causes loss of PLT function. Data indicate that the use of low anti-A and anti-B titer group O WB is safe as a universal donor, WB can be leukoreduced with PLT-sparing filters, and WB stored at 4°C retains PLT function during 15 days of storage. The understanding that these perceived barriers are not insurmountable will improve the availability of WB and facilitate its use. In addition, there are logistic and economic advantages of WB-based resuscitation compared to component therapy for hemorrhagic shock. The use of low-titer group O WB stored for up to 15 days at 4°C merits further study to compare its efficacy and safety with current resuscitation approaches for all patients with life-threatening bleeding., (© 2016 AABB.)

This review is a synopsis of the decisions that shaped global policy on platelet (PLT) storage temperature and a focused appraisal of the literature on which those discussions were based. We hypothesize that choices were centered on optimization of preventive PLT transfusion strategies, possibly to the detriment of the therapeutic needs of acutely bleeding patients. Refrigerated PLTs are a better hemostatic product, and they are safer in that they are less prone to bacterial contamination. They were abandoned during the 1970s because of the belief that clinically effective PLTs should both be hemostatically functional and survive in circulation for several days as indicated for prophylactic transfusion; however, clinical practice may be changing. Data from two randomized controlled trials bring into question the concept that stable autologous stem cell transplant patients with hypoproliferative thrombocytopenia should continue to receive prophylactic transfusions. At the same time, new findings regarding the efficacy of cold PLTs and their potential role in treating acute bleeding have revived the debate regarding optimal PLT storage temperature. In summary, a "one-size-fits-all" strategy for PLT storage may not be adequate, and a reexamination of whether cold-stored PLTs should be offered as a widely available therapeutic product may be indicated.

The Blood Far Forward (BFF) research program was established to conduct blood product efficacy and safety studies, donor performance studies, and research on optimal training methods to improve the safety of blood collection and transfusion performed by Norwegian Naval Special Operation Commando soldiers. The use of intravenous fluids for volume replacement during hemorrhagic shock is controversial, but it is currently the standard of care. In the far-forward environment, large volume resuscitation for massive bleeding is a great challenge. Crystalloid and colloid solutions add weight and bulk to the medic's kit, require temperature sensitive storage, and should be warmed before infusion to prevent hypothermia. Excessive use of these solutions causes a dilutional coagulopathy, acidosis, and potentially increased inflammatory injury compared with blood products. Type-specific whole blood from an uninjured combat companion on the other hand is almost always available. It is warm, replaces intravascular volume, and provides oxygen delivery and hemostatic capacity to prevent or treat shock and coagulopathy. Whole blood may be ideal for the resuscitation of combat casualties with hemorrhagic shock. BFF program pilot studies on use of platelet-sparing leukoreduction filters, whole blood transport tolerance, donor performance, and autologous reinfusion of 24-hour ambient temperature stored whole blood have been performed and suggest the feasibility of expanding whole blood use in resuscitation. If successful, the BFF program will change tactics, techniques, and procedures with a new lifesaving capability., (© 2013 American Association of Blood Banks.)