Conditions: Burns
Keywords: Burns
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

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 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.

Arms:
arm 1: intravenous administration of rFVIIa (Novoseven; 90 micrograms/kg, IV push, given at start of first surgical incision and again at 1 hr after start of surgery) arm 2: intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)

Interventions: intervention 1: Recombinant Factor VIIa intervention 2: Placebo
Intervention descriptions: intervention 1: intravenous infusion of Factor VIIa intervention 2: intravenous infusion of placebo (sterile water)

Protocol document: