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. 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

Study Overview

• Status: Completed
• Conditions: Anemia; Trauma; Blood Loss
• Intervention / Treatment: Biological: RBC units

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States
      • University of Cincinnati
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Texas
    • Dallas, Texas, United States
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States
      • University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue Oxygenation	Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.	Percentage of baseline (3 hours post transfusion compared to baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2,3 DPG Levels After Transfusion	2,3 DPG levels 12 hours after transfusion	12 hours post transfusion
Free Hemoglobin Levels After Transfusion	Free hemoglobin levels 12 hours after transfusion	12 hours after transfusion
Haptoglobin Levels 12 Hours After Transfusion	Haptoglobin levels after transfusion	12 hours after transfusion
Clinical Outcomes - Hospital Days	Clinical outcomes - Number of days admitted to the hospital within a 6 month window.	from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - ICU Days	Number of days admitted to the ICU during hospital admission	from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - Ventilator Days		from time of randomization through hospital discharged, assessed up to 6 months
Number of Participants With Acute Renal Failure	Number of participants who developed acute renal failure while hospitalized.	from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - Acute Respiratory Distress Syndrome	Number of subjects who developed acute respiratory distress syndrome while hospitalized.	from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - Infections	Number of subjects who developed infections while hospitalized.	from time of randomization through hospital discharged, assessed up to 6 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: United States Air Force; Armed Services Blood Program

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: December 23, 2009
• First Posted (Estimate): December 24, 2009

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: trauma; transfusion; red blood cells; frozen
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 002-01