Frozen Red Blood Cell Transfusions in Trauma Patients

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:

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

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

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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