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Introduction: We tested the efficacy and safety of fixed doses of Low-Molecular Weight Heparin (LMWH) in patients requiring interruption of Vitamin-k Antagonist (VKA) because of invasive procedures Methodology: Pre-operatively, patients discontinued VKA 5 +/- 1days; in those at low-risk for thrombosis, LMWH was given at a prophylactic dosage of 3.800 U.I. (nadroparin) or 4.000 U.I. (enoxaparin) anti-FXa once daily the night before the procedure. In patients at high-risk for thrombosis, LMWH was started early after VKA cessation and given at fixed sub-therapeutic doses (3.800 or 4.000 UI anti-FXa twice daily) until surgery. Post-operatively, LMWH was reinitiated 12 hours after procedure while VKA the day after. Heparin was continued until a therapeutic INR value was reached. The primary efficacy endpoints were the incidence of thromboembolism and major bleeding from VKA suspension (because of surgery) to 30 +/- 2 days post-procedure. Results: A total of 328 patients (55.4% at low-risk and 44.6% at high-risk for thrombosis) were enrolled; 103 (31.4%) underwent major surgery and 225 (68.6%) non major invasive procedures. Overall, thromboembolic events occurred in 6 patients (1.8%, 95% confidence intervals 0.4 to 3.2), 5 belonging to high-risk and 1 to low-risk group. Overall, major bleeding occurred in 7 patients (2.1%, 95 CI 0.6 to 3.6), 6 patients belonged to high-risk and 1 to low-risk group; most of events occurred in high-risk group during major surgery. Conclusion: LMWH given at fixed sub-therapeutic doses appears to be a feasible and safe approach for bridging therapy in chronic anticoagulated patients. Summary. Introduction: We tested the efficacy and safety of fixed doses of low-molecular-weight heparin (LMWH) in patients requiring interruption of vitamin-K antagonist (VKA) because of invasive procedures. Methodology: Preoperatively, patients discontinued VKA for 5 +/- 1 days; in those at low risk for thrombosis, LMWH was given at a prophylactic dosage of 3800 UI (nadroparin) or 4000 UI (enoxaparin) anti-factor (F) Xa once daily the night before the procedure. In patients at high risk for thrombosis, LMWH was started early after VKA cessation and given at fixed sub-therapeutic doses (3800 or 4000 UI anti-FXa twice daily) until surgery. Postoperatively, LMWH was reinitiated 12 h after procedure while VKA was reinitiated the day after. Heparin was continued until a therapeutic INR value was reached. The primary efficacy endpoints were the incidence of thromboembolism and major bleeding from VKA suspension (because of surgery) up to 30 +/- 2 days postprocedure. Results: A total of 328 patients (55.4% at low risk and 44.6% at high risk for thrombosis) were enrolled; 103 (31.4%) underwent major surgery and 225 (68.6%) non-major invasive procedures. Overall, thromboembolic events occurred in six patients (1.8%, 95% confidence interval 0.4-3.2), five belonging to the high-risk group and one belonging to the low-risk group. Overall, major bleeding occurred in seven patients (2.1%, 95 confidence interval 0.6-3.6), six patients belonged to the high-risk group and one belonged to the low-risk group; most of the events occurred in the high-risk group during major surgery. Conclusion: LMWH given at fixed sub-therapeutic doses appears to be a feasible and safe approach for bridging therapy in chronic anticoagulated patients

Hemostatic disorders can often complicate transplantation procedures. Moreover, antihemmorhagic drugs may not efficiently control bleeding that occurs in such cases. We report on a patient who underwent kidney transplantation complicated by bone marrow aplasia and gastric bleeding who was succesfully treated with recombinant activated FVII (Novoseven). In May 2005, a 53-year-old man affected by chronic renal insufficiency underwent kidney transplantation. At the beginning of June, laboratory tests showed progressive reduction in the blood cell count with anemia, granulocytopenia, and thrombocytopenia related to the development of marrow insufficiency. We commenced transfusion therapy and administered hematologic growth factors. On June 3, 2005, the patient underwent surgical procedure to repair the abdominal wall. Two days thereafter, the postsurgical period was complicated by an episode of melena. The patient received additional treatment with packed red cells, platelets, and fresh-frozen plasma. The gastrointestinal bleeding continued until June 9, 2005, when therapy with recombinant activated FVII (Novoseven) was commenced at an initial dose of 90 μgr/kg. The first bolus did not significantly reduce the blood loss; it was therefore administered as a successive bolus at the same dosage that was able to stop bleeding. Endoscopic examination performed the day after showed the absence of the hemorrhagic lesion in the gastric mucosa. In the subsequent days, the need for transfusion was dramatically reduced with no episode of bleeding. At the same time, the laboratory and clinical findings of marrow insufficiency disappeared. Our case report showed that the use of a global antihemorrhagic factor, such as Novoseven, can successfully control gastrointestinal bleeding even in complicated patients despite failure of traditional antihemostatic therapy.

Background. We have recently demonstrated that the presence of Residual Vein Thrombosis (RVT), UltraSonography (US)-detected at the 3rd month after an episode of Deep Vein Thrombosis (DVT) of the lower limbs, is an independent risk factor for developing recurrent Venous Thromboembolism (VTE). The management of DVT patients by detection of RVT may, therefore, represent a simple and reproducible method for establishing the individual risk of recurrence and for tailoring the optimal duration of Oral Anticoagulants (OA) (Siragusa S et al. Blood 2003;102(11):OC183a). At the present, it is unknown whether RVT may also identify patients at increased risk for cancer and/or cardiovascular disease (CD). Objective of the study. In patients with DVT of the lower limbs, we conducted a prospective study for evaluating the correlation between RVT and the risk of new overt cancer and/or CD. Materials and methods. Consecutive patients, with an episode of idiopathic or provoked DVT, were evaluated after 3 months from the index DVT; presence/absence of RVT was detected and patients managed consequently (table). The incidence of VTE recurrence, overt cancer and new CD was evaluated over a period of 3 years after the index DVT. Survival curves (Kaplan-Mayer) and related Breslow test have been used for statistics. Results. Three-hundred fourty-five patients were included in the analysis. The results are listed in the table and figures. The incidence of recurrent VTE and new overt cancer was statistically lower in patients without RVT than in those with RVT; no significant differences were found in the incidence of new CD. These data are applicable in patients with idiopathic or provoked index DVT. In patients with RVT, the advantage of prolonging anticoagulation for 12 months was lost at the end of the treatment. Conclusions. This is the first study evaluating the relationship between US-detected RVT and the risk of developing cancer and CD; RVT presence, at 3rd month from the index DVT, is an independent risk factor for recurrent VTE and indicates patients at risk for new overt cancer. This risk remains over a period of 3 years, independently whether index DVT was idiopathic or provoked. In these patients, the advantage of indefinite anticoagulation should be assessed in properly designed study. | Group | Number of patients | Presence of RVT at the 3rd months of OA from the index DVT | Duration of OA from the index DVT | Incidence of recurrent VTE | Incidence of new cancer | Incidence of new CD | |:----------------------------------------------------------------------------------:| ------------------ | ---------------------------------------------------------- | --------------------------------- | -------------------------- | ----------------------- | ------------------- | | *Part of these patients were originally randomized to receive 3 or 12 months of OA | | Group *A1 | 142 | yes | 12 months | 11 (7.7%) | 8 (5.6%) | 7 (4.9%) | | Group *A2 | 91 | yes | 3 months | 16 (17.5%) | 9 (9.9%) | 7 (7.7%) | | Group B | 112 | no | 3 months | 1 (0.9%) | 3 (2.6%) | 4 (3.5%) | Incidence of events over a period of 3 years accordingly to RVT findings ![Figure 1: ][1] Figure 1: Relationship between RVT and subsequent Cancer ![Figure 2: ][1] Figure 2: Relationship between RVT and subsequent Cardiovascular Event [1]: pending:yes