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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.
 
ClinicalTrials.gov Identifier: NCT01079247
Recruitment Status : Active, not recruiting
First Posted : March 3, 2010
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
U.S. Army Medical Research and Development 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 Not Applicable

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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 : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01079247


Locations
Show Show 18 study locations
Sponsors and Collaborators
American Burn Association
U.S. Army Medical Research and Development Command
Investigators
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Principal Investigator: Tina L Palmieri, MD University of California, Davis
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: American Burn Association
ClinicalTrials.gov Identifier: NCT01079247    
Other Study ID Numbers: ABA-MCTG-0001
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Keywords provided by American Burn Association:
Burn
Transfusion
blood
hemoglobin
Additional relevant MeSH terms:
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Burns
Wounds and Injuries