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

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ClinicalTrials.gov Identifier: NCT00243243
Recruitment Status : Completed
First Posted : October 21, 2005
Results First Posted : March 6, 2013
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Burns Drug: Recombinant Factor VIIa Drug: Placebo Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : January 2006
Primary Completion Date : June 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

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

Eligibility Criteria

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 Posted: October 21, 2005    Key Record Dates
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