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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00243243
First Posted: October 21, 2005
Last Update Posted: May 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
  Purpose
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.

Condition Intervention Phase
Burns Drug: Recombinant Factor VIIa Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Recombinant Coagulation Factor VIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn Excision and Grafting

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively [ Time Frame: 24 hours ]

Enrollment: 20
Study Start Date: January 2006
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243243


Locations
United States, Texas
United States Army Institute of Surgical Research
Ft Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: Myung S Park, MD United States Army Institute of Surgical Research
  More Information

Publications:
Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00243243     History of Changes
Other Study ID Numbers: H-05-027
First Submitted: October 19, 2005
First Posted: October 21, 2005
Results First Submitted: August 28, 2012
Results First Posted: March 6, 2013
Last Update Posted: May 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by United States Army Institute of Surgical Research:
Burns

Additional relevant MeSH terms:
Burns
Wounds and Injuries