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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Recombinant Coagulation Factor VIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn Excision and Grafting

Brief 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.

Detailed Summary: To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned patients, determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area, determine the efficacy of the drug in burned patients undergoing excision of burn wounds.
Sponsor: United States Army Institute of Surgical Research

Current Primary Outcome: Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively [ Time Frame: 24 hours ]

Original Primary Outcome: Reduce peri-operative blood loss and transfusion requirements

Current Secondary Outcome:

Original Secondary Outcome:

Information By: United States Army Institute of Surgical Research

Dates:
Date Received: October 19, 2005
Date Started: January 2006
Date Completion:
Last Updated: April 26, 2016
Last Verified: April 2016