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

This study is ongoing, but not recruiting participants.

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: December 8, 2016

Last verified: December 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

February 26, 2010

Last Updated Date

December 8, 2016

Start Date ^ICMJE

February 2010

Estimated Primary Completion Date

October 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Incidence of Blood Stream Infection [ Time Frame: At date of discharge for acute burn admission ]

Change History

Complete list of historical versions of study NCT01079247 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Burn Injury

Intervention ^ICMJE

Other: Restrictive transfusion threshold
maintain hemoglobin at 7-8 g/dL
Other: Liberal transfusion threshold
Maintain hemoglobin at 10-11 g/dL

Study Arms

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

347

Estimated Completion Date

October 2017

Estimated Primary Completion Date

October 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada, New Zealand, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01079247

Other Study ID Numbers ^ICMJE

ABA-MCTG-0001

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

American Burn Association

Study Sponsor ^ICMJE

American Burn Association

Collaborators ^ICMJE

U.S. Army Medical Research and Materiel Command

Investigators ^ICMJE

Principal Investigator:

Tina L Palmieri, MD

University of California, Davis

PRS Account

American Burn Association

Verification Date

December 2016

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

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