Frozen Red Blood Cell Transfusions in Trauma Patients

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status

Completed

Conditions

Anemia
Trauma
Blood Loss

Treatments

Biological: RBC units

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01038557
002-01

Details and patient eligibility

About

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: the transfused red blood cells' ability to delivery oxygen to the tissues differences in biochemical markers in subjects and units transfused, and how the subject's internal organs are working and if they develop any infections

Enrollment

254 patients

Sex

All

Ages

15 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

254 participants in 3 patient groups

Refrigerated RBCs 0-14 days old
Active Comparator group
Description:
Standard, refrigerated RBC units stored up to 14 days
Treatment:
Biological: RBC units
Refrigerated RBCs 15-42 days old
Active Comparator group
Description:
Standard, refrigerated RBC units stored 15-42 days
Treatment:
Biological: RBC units
Frozen RBCs
Experimental group
Description:
RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.
Treatment:
Biological: RBC units

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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