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Frozen Red Blood Cell Transfusions in Trauma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Oregon Health and Science University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
United States Air Force
Armed Services Blood Program
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01038557
First received: December 23, 2009
Last updated: March 11, 2010
Last verified: December 2009
History of Changes
  Purpose

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 Intervention
Transfusion
 Biological: Red Blood Cells

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Frozen Red Blood Cells for Transfusion in Trauma Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Tissue Oxygenation [ Time Frame: Daily ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biochemical changes in the red blood cells [ Designated as safety issue: Yes ]
  • Clinical outcomes [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: January 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Martin Schreiber, MD, OHSU
ClinicalTrials.gov Identifier: NCT01038557     History of Changes
Other Study ID Numbers: 002-01
Study First Received: December 23, 2009
Last Updated: March 11, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013