TAILIEUCHUNG - Recombinant factor VIIa in severe trauma: further study needed

Citation Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y: Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebocontrolled, double-blind clinical trials. J | Available online at http content 10 3 308 University of Pittsburgh Department of Critical Care Medicine Evidence-Based Medicine Journal Club EBM Journal Club Section Editor Eric B. Milbrandt MD MPH Journal club critique Recombinant factor Vila in severe trauma further study needed Dan A. Galvan1 and Mitchell P. Fink2 1 Clinical Fellow Department of Critical Care Medicine University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA 2 Professor and Chair Departments of Critical Care Medicine University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA Published online 2 May 2006 This article is online at http content 10 3 308 2006 BioMed Central Ltd Crit Care 10 308 DOI cc4931 Expanded Abstract Citation Boffard KD Riou B Warren B Choong PI Rizoli S Rossaint R Axelsen M Kluger Y Recombinant factor Vila as adjunctive therapy for bleeding control in severely injured trauma patients two parallel randomized placebo-controlled double-blind clinical trials. J Trauma 2005 59 815 1 . Background Uncontrolled bleeding is a leading cause of death in trauma. Two randomized placebo-controlled double-blind trials one in blunt trauma and one in penetrating trauma were conducted simultaneously to evaluate the efficacy and safety of recombinant factor VIIa rFVIIa as adjunctive therapy for control of bleeding in patients with severe blunt or penetrating trauma. Methods Design Two parallel randomized placebo-controlled double-blind clinical trials. Setting Thirty-two hospitals throughout Australia Canada France Germany Israel Singapore South Africa and the United Kingdom. intervention Severely bleeding trauma patients were randomized to rFVIla 200 100 and 100 g kg or placebo in addition to standard treatment. The first dose followed transfusion of the eighth red blood cell RBC unit with additional doses 1 and 3 hours later. Outcomes The primary endpoint for bleeding control in patients alive at 48 hours was units of RBCs transfused .

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