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

United States Army Institute of Surgical Research

Status and phase: Completed; Phase 3

Conditions: Burns

Treatments: Drug: Placebo; Drug: Recombinant Factor VIIa

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00243243

H-05-027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

rFVIIa

Experimental group

Description:

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)

Treatment:

Drug: Recombinant Factor VIIa

Control

Placebo Comparator group

Description:

intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)

Treatment:

Drug: Placebo