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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:
Information provided by:

Study Description
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. 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

Condition or disease Intervention/treatment
Transfusion Biological: Red Blood Cells

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Frozen Red Blood Cells for Transfusion in Trauma Patients
Study Start Date : January 2010
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Refrigerated RBCs 0-14 days old Biological: Red Blood Cells
Active Comparator: Regrigerated RBCs 15-42 days old Biological: Red Blood Cells
Experimental: Frozen RBCs Biological: Red Blood Cells


Outcome Measures

Primary Outcome Measures :
  1. Tissue Oxygenation [ Time Frame: Daily ]

Secondary Outcome Measures :
  1. Biochemical changes in the red blood cells
  2. Clinical outcomes

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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


Contacts
Contact: Jodie Curren, BSN 503 418-2101 currenjo@ohsu.edu
Contact: Samantha Underwood, MS 503 494-8481 underwos@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Jodie Curren, BSN    503-418-2101    currenjo@ohsu.edu   
Sub-Investigator: Jennifer Watters, MD         
Sub-Investigator: Susan Rowell, MD         
Sub-Investigator: Laszlo Kiraly, MD         
Sub-Investigator: Jerome Differding, MPH         
Sub-Investigator: Samantha Underwood, MS         
Sub-Investigator: Kim Simmons, BSN         
Principal Investigator: Martin Schreiber, MD         
Sub-Investigator: Jodie Curren, BSN         
Sponsors and Collaborators
Oregon Health and Science University
United States Air Force
Armed Services Blood Program
Investigators
Principal Investigator: Martin Schreiber, MD Oregon Health and Science University
More Information

Responsible Party: Martin Schreiber, MD, OHSU
ClinicalTrials.gov Identifier: NCT01038557     History of Changes
Other Study ID Numbers: 002-01
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: March 12, 2010
Last Verified: December 2009

Keywords provided by Oregon Health and Science University:
frozen
red blood cells
transfusion
trauma