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A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
American Burn Association
ClinicalTrials.gov Identifier:
NCT01079247
First received: February 26, 2010
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to find out if burn injured patients do better receiving fewer blood transfusions than what is traditionally given. We traditionally provide blood transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter and is the standard measurement used to indicate the level of red blood cells in your blood). However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8 g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above, would reduce the occurrence of blood infection, duration on the respirator and length of hospital stay, yet would achieve similar survival in both groups.


Condition Intervention Phase
Burn Injury
 Other: Traditional transfusion threshold
Other: Restrictive transfusion threshold
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by American Burn Association:

Primary Outcome Measures:
  • Incidence of Blood Stream Infection [ Time Frame: 1 week after randomization and weekly thereafter through discarge from hospital ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional
Maintain hemoglobin at 10-11 g/dL
 Other: Traditional transfusion threshold
maintain hemoglobin at 10-11 g/dL
Active Comparator: Restrictive
Maintain hemoglobin at 7-8 g/dL
 Other: Restrictive transfusion threshold
maintain hemoglobin at 7-8 g/dL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >20% TBSA burn with anticipated operation need on admission as determined by attending physician
  • age >18 years
  • Admission within 96 hours of injury

Exclusion Criteria:

  • <18 years of age
  • pregnancy
  • inability or unwillingness to receive blood products
  • history of chronic anemia (hemoglobin <9.0 g/dL one month prior to enrollment)
  • preexisting need for hemodialysis
  • brain death or imminent brain death
  • non-survivable burn as determined by the attending burn surgeon
  • angina or acute myocardial infarction
  • preexisting hematologic disease
  • Length of hospital stay anticipated to be < 2 weeks
  • Transfusion administered at outside hospital before admit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079247

Locations
United States, Arizona
Maricopa Integrated Health System (Arizona Burn Center)
Phoenix, Arizona, United States, 85008-4973
United States, California
Arrowhead Regional Medical Center
Colton, California, United States, 92324
Community Regional Medical Center
Fresno, California, United States, 93721
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, United States, 95817
United States, District of Columbia
Washington Hospital Burn Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida Health Science
Gainesville, Florida, United States, 32610
United States, Georgia
Doctors Hospital-Joseph M Still Burn Center
Agusta, Georgia, United States, 30909
United States, North Carolina
University of North Carolina at Chapel Hill (Jaycee Burn Center)
Chapel Hill, North Carolina, United States, 27599
Wake Forest University
Wiston Salem, North Carolina, United States, 27157
United States, Ohio
Ohio State University Burn Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Burn Center Legacy Health System
Portland, Oregon, United States, 97232
United States, Texas
University of Texas SouthWestern Medical Center
Dallas, Texas, United States, 75390-9158
U.S. Army Institute of Surgical Research (USAISR)
Fort Sam Houston, Texas, United States, 78234
United States, Utah
University of Utah Intermountain School of Medicine
Salt Lake City, Utah, United States, 84132
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G2B 7
Canada, Ontario
Sunnybrook Health Science Center
Toronto, Ontario, Canada, M4J2N4
New Zealand
New Zealand National Burn Centre-Middlemore Hospital
Auckland, New Zealand, 1640
Sponsors and Collaborators
American Burn Association
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Tina L Palmieri, MD University of California, Davis
  More Information

No publications provided

Responsible Party: American Burn Association
ClinicalTrials.gov Identifier: NCT01079247     History of Changes
Other Study ID Numbers: ABA-MCTG-0001
Study First Received: February 26, 2010
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by American Burn Association:
Burn
Transfusion
blood
hemoglobin

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013