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

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. Identifier: NCT01079247
Recruitment Status : Active, not recruiting
First Posted : March 3, 2010
Last Update Posted : December 12, 2016
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
American Burn Association

Brief Summary:
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 or disease Intervention/treatment Phase
Burn Injury Other: Restrictive transfusion threshold Other: Liberal transfusion threshold Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
Study Start Date : February 2010
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Liberal
Maintain hemoglobin at 10-11 g/dL
Other: Liberal 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

Primary Outcome Measures :
  1. Incidence of Blood Stream Infection [ Time Frame: 1 week after randomization and weekly thereafter through discarge from hospital ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01079247

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
University of California, San Diego
San Diego, California, United States, 92103
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, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
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, 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
Principal Investigator: Tina L Palmieri, MD University of California, Davis

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: American Burn Association Identifier: NCT01079247     History of Changes
Other Study ID Numbers: ABA-MCTG-0001
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016

Keywords provided by American Burn Association:

Additional relevant MeSH terms:
Wounds and Injuries
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents