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

April 26, 2016 updated by: United States Army Institute of Surgical Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Ft Sam Houston, Texas, United States, 78234
        • United States Army Institute of Surgical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rFVIIa
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)
Drug: Recombinant Factor VIIa
intravenous infusion of Factor VIIa
Placebo Comparator: Control
intravenous administration of placebo (sterile water, IV push, given at first surgical incision and again at 1 hr after start of surgery)
Drug: Placebo
intravenous infusion of placebo (sterile water)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Army Institute of Surgical Research

Investigators

  • Principal Investigator: Myung S Park, MD, United States Army Institute of Surgical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-05-027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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