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

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.

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.

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