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Frozen Red Blood Cell Transfusions in Trauma Patients

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ClinicalTrials.gov Identifier: NCT01038557
Recruitment Status : Unknown
Verified December 2009 by Oregon Health and Science University.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2009
Last Update Posted : March 12, 2010
Sponsor:
Collaborators:
United States Air Force
Armed Services Blood Program
Information provided by:
Oregon Health and Science University

December 23, 2009
December 24, 2009
March 12, 2010
January 2010
August 2010   (Final data collection date for primary outcome measure)
Tissue Oxygenation [ Time Frame: Daily ]
Same as current
Complete list of historical versions of study NCT01038557 on ClinicalTrials.gov Archive Site
  • Biochemical changes in the red blood cells
  • Clinical outcomes
Same as current
Not Provided
Not Provided
 
Frozen Red Blood Cell Transfusions in Trauma Patients
Efficacy and Safety of Frozen Red Blood Cells for Transfusion in Trauma Patients

The purpose of this study is to look at red blood cell(RBC)transfusions in trauma patients and evaluate for any differences between the age of the RBCs and how they were stored. The investigators will specifically look for the following differences between study groups:

  1. the transfused red blood cells' ability to delivery oxygen to the tissues
  2. changes in the how the RBCs' look or act under a microscope and
  3. how the subject's internal organs are working and if they develop any infections
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Transfusion
Biological: Red Blood Cells
  • Active Comparator: Refrigerated RBCs 0-14 days old
    Intervention: Biological: Red Blood Cells
  • Active Comparator: Regrigerated RBCs 15-42 days old
    Intervention: Biological: Red Blood Cells
  • Experimental: Frozen RBCs
    Intervention: Biological: Red Blood Cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
350
Same as current
February 2011
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients admitted to the OHSU Trauma Service
  • Injury Severity Score > 4
  • Transfusion of PRBCs is ordered
  • Transfusion is not emergent
  • Able to obtain consent from patient or appropriate 3rd party prior to 1st transfusion

Exclusion Criteria:

  • Inability to adhere to blood age randomization due to limitations of the blood bank inventory
  • Bilateral hand injuries that prevent StO2 measurements
  • Age < 15
  • Pregnancy
  • Presence of oral mucosa lacerations preventing sidestream dark field imaging
  • Transfusion of PRBCs or whole blood in last 3 months
  • Hemodynamically unstable or need for transfusion in < 3 hours
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01038557
002-01
Yes
Not Provided
Not Provided
Martin Schreiber, MD, OHSU
Oregon Health and Science University
  • United States Air Force
  • Armed Services Blood Program
Principal Investigator: Martin Schreiber, MD Oregon Health and Science University
Oregon Health and Science University
December 2009

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