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Recombinant activated factor VII for adjunctive hemorrhage control in trauma
U Martinowitz1, G Kenet, E Segal
1National Hemophilia Center, Chaim Sheba Medical Center, Tel Hashomer 52621, Israel. hemophil@trendline.co.il
The Journal of Trauma
|September 6, 2001
Summary
Recombinant activated factor VII (rFVIIa) effectively stopped severe bleeding in trauma patients when conventional methods failed. This suggests rFVIIa may be a valuable adjunctive hemostatic agent for critical trauma care.
Area of Science:
- Trauma care
- Hemostasis
- Coagulation disorders
Background:
- Recombinant activated factor VII (rFVIIa) is approved for hemophilia patients with inhibitors.
- Contraindications for rFVIIa include conditions with increased thromboembolic risk, such as trauma.
- rFVIIa's mechanism suggests localized hemostasis, making its use in trauma rational.
Purpose of the Study:
- To evaluate the efficacy and safety of rFVIIa in massively bleeding, coagulopathic trauma patients.
- To determine if rFVIIa can achieve hemostasis when conventional measures fail.
Main Methods:
- Seven massively bleeding trauma patients with coagulopathy received rFVIIa after failure of standard treatments.
- Patients received a median dose of 120 microg/kg rFVIIa.
- Median transfusion was 40 units of packed cells prior to rFVIIa administration.
Main Results:
- rFVIIa administration led to cessation of diffuse bleeding.
- Significant reduction in packed cell requirements (median 2 units) and normalization of coagulation times (PT, aPTT).
- Increased FVII levels were observed; three patients died from causes other than bleeding or thromboembolism.
Conclusions:
- rFVIIa may serve as an adjunctive hemostatic agent in trauma patients with uncontrolled hemorrhage.
- These findings support further investigation through controlled animal and clinical trials.
- rFVIIa offers a potential new option for managing life-threatening trauma-related bleeding.