Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: Two parallel randomized, placebo-controlled, double-blind clinical trials

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dc.contributor.authorBoffard K.D.
dc.contributor.authorRiou B.
dc.contributor.authorWarren B.
dc.contributor.authorChoong P.I.T.
dc.contributor.authorRizoli S.
dc.contributor.authorRossaint R.
dc.contributor.authorAxelsen M.
dc.contributor.authorKluger Y.
dc.contributor.authorChampion H.R.
dc.contributor.authorLucas C.
dc.contributor.authorThompson E.
dc.contributor.authorRoss S.
dc.contributor.authorJurkovich G.J.
dc.contributor.authorLynn M.
dc.contributor.authorPitts L.
dc.contributor.authorCroce M.A.
dc.date.accessioned2011-05-15T16:17:11Z
dc.date.available2011-05-15T16:17:11Z
dc.date.issued2005
dc.description.abstractBackground: 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. Methodsd: Severely bleeding trauma patients were randomized to rFVIIa (200, 100, and 100 μg/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. The primary endpoint for bleeding control in patients alive at 48 hours was units of RBCs transfused within 48 hours of the first dose. Results: Among 301 patients randomized, 143 blunt trauma patients and 134 penetrating trauma patients were eligible for analysis. In blunt trauma, RBC transfusion was significantly reduced with rFVIIa relative to placebo (estimated reduction of 2.6 RBC units, p = 0.02), and the need for massive transfusion (>20 units of RBCs) was reduced (14% vs. 33% of patients; p = 0.03). In penetrating trauma, similar analyses showed trends toward rFVIIa reducing RBC transfusion (estimated reduction of 1.0 RBC units, p = 0.10) and massive transfusion (7% vs. 19%; p = 0.08). Trends toward a reduction in mortality and critical complications were observed. Adverse events including thromboembolic events were evenly distributed between treatment groups. Recombinant FVIIa resulted in a significant reduction in RBC transfusion in severe blunt trauma. Similar trends were observed in penetrating trauma. The safety of rFVIIa was established in these trauma populations within the investigated dose range. Copyright © 2005 by Lippincott Williams & Wilkins, Inc.
dc.description.versionArticle
dc.identifier.citationJournal of Trauma - Injury, Infection and Critical Care
dc.identifier.citation59
dc.identifier.citation1
dc.identifier.issn00225282
dc.identifier.other10.1097/01.TA.0000171453.37949.B7
dc.identifier.urihttp://hdl.handle.net/10019.1/14109
dc.subjectplacebo
dc.subjectrecombinant blood clotting factor 7a
dc.subjectadolescent
dc.subjectadult
dc.subjectarticle
dc.subjectbleeding
dc.subjectblunt trauma
dc.subjectbrain infarction
dc.subjectcause of death
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdeep vein thrombosis
dc.subjectdose response
dc.subjectdouble blind procedure
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjecterythrocyte transfusion
dc.subjectfemale
dc.subjecthuman
dc.subjectinjury
dc.subjectintestine infarction
dc.subjectlung embolism
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmesenteric vein thrombosis
dc.subjectmortality
dc.subjectpenetrating trauma
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjectthromboembolism
dc.subjectvein thrombosis
dc.subjectAdult
dc.subjectChi-Square Distribution
dc.subjectDouble-Blind Method
dc.subjectErythrocyte Transfusion
dc.subjectFactor VIIa
dc.subjectFemale
dc.subjectHemorrhage
dc.subjectHemostasis
dc.subjectHumans
dc.subjectMale
dc.subjectStatistics, Nonparametric
dc.subjectTreatment Outcome
dc.subjectWounds and Injuries
dc.titleRecombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: Two parallel randomized, placebo-controlled, double-blind clinical trials
dc.typeArticle
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