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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01079247




Registration number
NCT01079247
Ethics application status
Date submitted
26/02/2010
Date registered
3/03/2010
Date last updated
4/08/2023

Titles & IDs
Public title
A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients
Scientific title
A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
Secondary ID [1] 0 0
ABA-MCTG-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Restrictive transfusion threshold
Other interventions - Liberal transfusion threshold

Active comparator: Liberal - Maintain hemoglobin at 10-11 g/dL

Active comparator: Restrictive - Maintain hemoglobin at 7-8 g/dL


Other interventions: Restrictive transfusion threshold
maintain hemoglobin at 7-8 g/dL

Other interventions: Liberal transfusion threshold
Maintain hemoglobin at 10-11 g/dL
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Blood Stream Infection
Timepoint [1] 0 0
1 week after randomization and weekly thereafter through discarge from hospital

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2016
Sample size
Target
Accrual to date
Final
347
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
American Burn Association
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
U.S. Army Medical Research and Development Command
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tina L Palmieri, MD
Address 0 0
University of California, Davis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01079247