NCT00243243

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: United States Army Institute of Surgical Research · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Burns

Interventions

Type	Name	Description
DRUG	Recombinant Factor VIIa	intravenous infusion of Factor VIIa
DRUG	Placebo	intravenous infusion of placebo (sterile water)

Timeline

• Start date: 2006-01-01
• Primary completion: 2011-06-01
• Completion: 2011-07-01
• First posted: 2005-10-21
• Last updated: 2016-05-26
• Results posted: 2013-03-06

Locations

1 site across 1 country: United States