Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn

Phase 3 Completed 20 enrolled United States Army Institute of Surgical Research

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower the amount of blood lost during burn surgery.

Timeline

Start: 2006-01
Primary completion: 2011-06
Completion: 2011-07

Publications

Background Deveras RA, Kessler CM. Reversal of warfarin-induced excessive anticoagulation with recombinant human factor VIIa concentrate. Ann Intern Med. 2002 Dec 3;137(11):884-8. doi: 10.7326/0003-4819-137-11-200212030-00009.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Recombinant Factor VIIa	Protein / enzyme biologic	90 ug/kg	Intravenous

Indications

No indication recorded.