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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United States Army Institute of Surgical Research

Criteria

Inclusion Criteria:

• Male or female

• Burn wounds

• 18-65 years of age

• Scheduled excision of burn wound of at least 20 percent TBSA

Exclusion Criteria:

• Age greater than 65 years

• History of blood coagulation disorders

• Taking anti-coagulation medication

• Contraindication for heparin therapy

• Pregnant or nursing females

• Unstable angina

• MI within the last 6 months

• Recent of diagnosis of DVT, stroke within the last 6 months

• Renal failure requiring dialysis or creatinine clearance less than 25 ml/min

• Religious prohibition to blood transfusion

• Have received rFVIIa during current hospitalization

• Previous enrollment in this study