Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy : subgroup analysis from two randomized trials

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dc.contributor.authorRizoli, Sandro B.
dc.contributor.authorBoffard, Kenneth D.
dc.contributor.authorRiou, Bruno
dc.contributor.authorWarren, Brian
dc.contributor.authorIau, Philip
dc.contributor.authorKluger, Yoram
dc.contributor.authorRossaint, Rolf
dc.contributor.authorTillinger, Michael
dc.contributor.authorNovoSeven Trauma Study Group
dc.date.accessioned2010-12-14T08:58:28Z
dc.date.available2010-12-14T08:58:28Z
dc.date.issued2006-12
dc.date.updated2010-11-09T12:53:05Z
dc.description.abstractIntroduction: We conducted a post-hoc analysis on the effect of recombinant factor VIIa (rFVIIa) on coagulopathic patients from two randomized, placebo-controlled, double-blind trials of rFVIIa as an adjunctive therapy for bleeding in patients with severe trauma. Methods: Blunt and penetrating trauma patients were randomly assigned to rFVIIa (200 + 100 + 100 μg/kg) at 0, 1, and 3 hours after transfusion of 8 units of red blood cells (RBCs) or to placebo. Subjects were monitored for 48 hours post-dosing and followed for 30 days. Coagulopathy was retrospectively defined as transfusion of fresh frozen plasma (FFP) (>1 unit of FFP per 4 units of RBCs), FFP in addition to whole blood, and transfusion of platelets and/or cryoprecipitate. Results: Sixty rFVIIa-treated and 76 placebo subjects were retrospectively identified as being coagulopathic. No significant differences were noted in baseline characteristics. The rFVIIa-treated coagulopathic subgroup consumed significantly less blood product: RBC transfusion decreased by 2.6 units for the whole study population (P = 0.02) and by 3.5 units among patients surviving more than 48 hours (P < 0.001). Transfusion of FFP (1,400 versus 660 ml, P < 0.01), platelet (300 versus 100 ml, P = 0.01), and massive transfusions (29% versus 6%, P < 0.01) also dropped significantly. rFVIIa reduced multi-organ failure and/or acute respiratory distress syndrome in the coagulopathic patients (3% versus 20%, P = 0.004), whereas thromboembolic events were equally present in both groups (3% versus 4%, P = 1.00). Conclusion: Coagulopathic trauma patients appear to derive particular benefit from early adjunctive rFVIIa therapy.en_ZA
dc.description.versionPeer Reviewed
dc.format.extent11 p. : ill.
dc.identifier.citationRizoli, SB, Boffard, KD, Riou, B, Warren, B, Lau, P, Kluger, Y, Rossaint, R, Tillinger, M & NovoSeven® Trauma Study Group 2006, 'Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials', Critical Care, 10(6):R178.en_ZA
dc.identifier.issn1364-8535
dc.identifier.otherhttp://dx.doi.org/10.1186/cc5133
dc.identifier.urihttp://hdl.handle.net/10019.1/5088
dc.language.isoen_ZAen_ZA
dc.publisherBioMed Centralen_ZA
dc.rights.holderRizoli et al.; licensee BioMed Central Ltd.en_ZA
dc.subjectRecombinant factor VIIa (rFVIIa)en_ZA
dc.subjectBleeding in patients with severe traumaen_ZA
dc.subjectHemorrhagic shocken
dc.titleRecombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy : subgroup analysis from two randomized trialsen_ZA
dc.typeArticleen_ZA
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