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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: July 16, 2013
Last verified: July 2013

February 26, 2010
July 16, 2013
February 2010
October 2014   (final data collection date for primary outcome measure)
Incidence of Blood Stream Infection [ Time Frame: 1 week after randomization and weekly thereafter through discarge from hospital ] [ Designated as safety issue: No ]
Incidence of Blood Stream Infection [ Time Frame: At date of discharge for acute burn admission ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01079247 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients
A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burn Injury
  • Other: Restrictive transfusion threshold
    maintain hemoglobin at 7-8 g/dL
  • Other: Liberal transfusion threshold
    Maintain hemoglobin at 10-11 g/dL
  • Active Comparator: Liberal
    Maintain hemoglobin at 10-11 g/dL
    Intervention: Other: Liberal transfusion threshold
  • Active Comparator: Restrictive
    Maintain hemoglobin at 7-8 g/dL
    Intervention: Other: Restrictive transfusion threshold
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   New Zealand
 
NCT01079247
ABA-MCTG-0001
Yes
American Burn Association
American Burn Association
U.S. Army Medical Research and Materiel Command
Principal Investigator: Tina L Palmieri, MD University of California, Davis
American Burn Association
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP