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Completed

NCT Number: NCT00243243

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

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.

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

United States Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant Factor VIIa

Drug

intravenous infusion of Factor VIIa

Placebo

Drug

intravenous infusion of placebo (sterile water)

Primary outcomes

  1. Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

United States Army Institute of Surgical Research

Fed

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Oct 21, 2005
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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