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Frozen Red Blood Cell Transfusions in Trauma Patients

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ClinicalTrials.gov Identifier: NCT01038557
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
United States Air Force
Armed Services Blood Program
Information provided by (Responsible Party):
Martin A Schreiber, MD, Oregon Health and Science University

Brief Summary:

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. differences in biochemical markers in subjects and units transfused, and
  3. how the subject's internal organs are working and if they develop any infections

Condition or disease Intervention/treatment Phase
Blood Loss Anemia Trauma Biological: RBC units Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Frozen Red Blood Cells for Transfusion in Trauma Patients
Study Start Date : January 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Refrigerated RBCs 0-14 days old
Standard, refrigerated RBC units stored up to 14 days
Biological: RBC units
When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.

Active Comparator: Refrigerated RBCs 15-42 days old
Standard, refrigerated RBC units stored 15-42 days
Biological: RBC units
When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.

Experimental: Frozen RBCs
RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.
Biological: RBC units
When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.




Primary Outcome Measures :
  1. Tissue Oxygenation [ Time Frame: from baseline through 12 hours post transfusion ]
    Assessment of tissue oxygenation by NIRS in subjects before, during, and up to 12 hours after PRBC transfusion.


Secondary Outcome Measures :
  1. Biochemical changes in the red blood cells [ Time Frame: up to 24 hours ]
    Assessment of changes in 2,3-DPG, free hemoglobin, haptoglobin, and inflammatory markers in subject pre and post transfusions and in each PRBC unit transfused.

  2. Clinical outcomes [ Time Frame: from time of randomization through hospital discharged, assessed up to 6 months ]
    Overall clinical outcomes (LOS, Ventilator days, MOF, renal failure, infections, etc) from time of study transfusion through hospital discharge



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Ages Eligible for Study:   15 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Trauma Service with an Injury Severity Score > 4
  • Require a blood (PRBC) transfusion
  • 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
  • Massive transfusion (=/> 10 units in 24 hours) in last 3 months
  • Hemodynamically unstable or need for transfusion in < 3 hours

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): NCT01038557


Locations
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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Sponsors and Collaborators
Oregon Health and Science University
United States Air Force
Armed Services Blood Program
Investigators
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Principal Investigator: Martin Schreiber, MD Oregon Health and Science University

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Responsible Party: Martin A Schreiber, MD, Professor & Chief of Trauma, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01038557     History of Changes
Other Study ID Numbers: 002-01
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Keywords provided by Martin A Schreiber, MD, Oregon Health and Science University:
frozen
red blood cells
transfusion
trauma
Additional relevant MeSH terms:
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Wounds and Injuries