Recombinant factor VIIa is associated with an improved 24-hour survival without an improvement in inpatient survival in massively transfused civilian trauma patients

OBJECTIVE: To determine whether recombinant factor VIIa (rFVIIa) is associated with increased survival and/or thromboembolic complications. INTRODUCTION: Uncontrollable hemorrhage is the main cause of early mortality in trauma. rFVIIa has been suggested for the management of refractory hemorrhage. However, there is conflicting evidence about the survival benefit of rFVIIa in trauma. Furthermore, recent reports have raised concerns about increased thromboembolic events with rFVIIa use. METHODS: Consecutive massively transfused (> 8 units of red blood cells within 12 h) trauma patients were studied. Data on demographics, injury severity scores, baseline laboratory values and use of rFVIIa were collected. Rate of transfusion in the first 6 h was used as surrogate for bleeding. Study outcomes included 24-hour and in-hospital survival, and thromboembolic events. A multivariable logistic regression analysis was used to determine the impact of rFVIIa on 24-hour and in-hospital survival. RESULTS: Three-hundred and twenty-eight patients were massively transfused. Of these, 72 patients received rFVIIa. As expected, patients administered rFVIIa had a greater degree of shock than the non-rFVIIa group. Using logistic regression to adjust for predictors of death in the regression analysis, rFVIIa was a significant predictor of 24-hour survival (odds ratio (OR) = 2.65; confidence interval 1.26-5.59; p = 0.01) but not of in-hospital survival (OR = 1.63; confidence interval 0.79-3.37; p = 0.19). No differences were seen in clinically relevant thromboembolic events. CONCLUSIONS: Despite being associated with improved 24-hour survival, rFVIIa is not associated with a late survival to discharge in massively transfused civilian trauma patients.

Recombinant activated factor VII in controlling bleeding in non-hemophiliac patients

There have been recent reports on the successful use of recombinant factor Vila [rFVIIa] in non-hemophiliac patients who have experienced heavy blood loss due to trauma with extensive organ damage and who have received multiple blood transfusions with hemostatic changes without success. The timing of administration, dosage, mortality, units of blood transfusion saved, risk of thrombotic events, and the risk/benefit ratio are still poorly defined. We conducted a retrospective review of all medical records of patients who received rFVIIa between January 2003 and March 2008. Data collection included demographic characteristics, diagnosis, indications, comorbidities, and amount of blood products used with rFVIIa, dose of rFVIIa, mortality, and adverse events. We identified 45 patients, 27 [60%] males and 18 [40%] females, with a median age of 52 years. The median dose of rFVIIa was 40 micro g/kg [range, 20-120 micro g/kg]. Five [11.1%] patients needed a second dose of rFVIIa [dose range of 20-85 micro g/kg] whereas three patients [6.7%] needed a third dose of rFVIIa [dose range of 40-60 micro g/kg]. There was a marked and significant reduction in transfusion requirements for packed red blood cells [P=.0078]. Overall transfusion requirements significantly decreased after the infusion of rFVIIa [P=.0323]. Nineteen patients [42.2%] died and thrombosis was documented in 3 patients [6.7%].Use of rFVIIa should be based on sound clinical evidence to balance the risks, benefits, and cost if used among non-hemophiliacs. Prospective randomized studies are needed to investigate the efficacy and cost-effectiveness of rFVIIa for this indication and to allow a final assessment of the importance of this treatment

Uso de factor VII en el control de sangrados perioperatorios: evidencias actuales / Recombinant activated factor VII for perioperative bleeding

Recombinant activated factor VII (rFVIIa) is a new haemostatic drug, originally used for the treatment of patients with hemophilia A and B. At the present time it is used for other bleeding conditions such as the perioperative period. When used prophylactically there is a reduction in the number of bleeding episodes but no changes in the need for blood transfusion or other blood products. The adverse effects are arterial or venous thromboembolic events that are mostly related to the severity of the underlying disease of the patient and the concurrent administration of other haemostatic agents, rather than the use of rFVIIa. Its use is recommended when there is a persistent bleeding after the reposition of blood products and when surgical causes of bleeding have been discarded. The cost of the medication should also be considered before its use.