The treatment of bleeding is to stop the bleeding! Treatment of trauma-related hemorrhage
Date
2009
Authors
Boffard K.D.
Choong P.I.T.
Kluger Y.
Riou B.
Rizoli S.B.
Rossaint R.
Warren B.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
The secret with any alternative to transfusion is to minimize the need for transfusion in the first place. This can be done by reducing the volume of blood loss. The volume of blood being lost can be reduced by direct methods where possible (i.e., hemostasis at the point of bleeding), or by improving the coagulation profile of the patient, thereby improving the extrinsic coagulation. Recombinant activated factor VII (rFVIIa) offers theoretical possibilities of improving the coagulation profile. STUDY DESIGN AND METHODS: The efficacy and safety of rFVIIa for the treatment of bleeding in patients with severe blunt and penetrating trauma has been investigated in two double-blind, placebo-controlled studies within a single trial - one on patients with blunt injury and the other in similar patients with penetrating injury. RESULTS: In patients with blunt trauma alive at 48 hours, treatment with rFVIIa effected a significant reduction in the primary endpoint of 48-hour red blood cell (RBC) transfusion requirement (p = 0.02), and the safety of the dosing regimen was established. Similar trends were observed in patients with penetrating injuries. Across both studies and treatment arms, the 48-hour mortality rate ranged from 16 to 19 percent. In the blunt trauma study, this equated to 13 patients from each arm who died before the benefits of treatment could be adequately assessed. Analysis of data for the 117 blunt trauma patients who survived at least 48 hours after receiving study treatment shows that, in addition to reducing RBC requirement, rFVIIa significantly reduced the need for massive transfusion over 48 hours (>20 RBC units) (relative risk reduction of 56% [95% confidence interval: 9%-79%]; p = 0.03), and the fresh-frozen plasma (p = 0.036), platelet (p = 0.023), and cryoprecipitate (p = 0.053) requirements within 48 hours, and was associated with a significant reduction in the 30-day risk of acute respiratory distress syndrome (ARDS) (p = 0.05) and multiple organ failure and/or ARDS (p = 0.05). CONCLUSION: Treatment with adjunctive rFVIIa significantly reduces transfusion requirements in the 48 hours after severe injury and these procoagulant effects may improve clinical outcome at 30 days. © 2009 American Association of Blood Banks.
Description
Keywords
fresh frozen plasma, placebo, recombinant blood clotting factor 7a, adult respiratory distress syndrome, bleeding, blood transfusion, blunt trauma, clinical trial, controlled clinical trial, controlled study, cryoprecipitate, double blind procedure, drug efficacy, drug safety, erythrocyte transfusion, hemostasis, human, injury severity, major clinical study, mortality, multiple organ failure, penetrating trauma, randomized controlled trial, review, risk reduction, statistical analysis, thrombocyte transfusion, thromboembolism, trauma related hemorrhage, Adolescent, Adult, Aged, Blood Transfusion, Double-Blind Method, Drug Toxicity, Factor VIIa, Hemorrhage, Humans, Incidence, Middle Aged, Multiple Organ Failure, Placebos, Recombinant Proteins, Respiratory Distress Syndrome, Adult, Survival Rate, Treatment Outcome, Wounds and Injuries, Wounds, Nonpenetrating, Wounds, Penetrating, Young Adult
Citation
Transfusion
49
SUPPL.5
49
SUPPL.5