Frozen Red Blood Cell Transfusions in Trauma Patients

NCT ID: NCT01038557

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-05-31

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. 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

Conditions

Blood Loss; Anemia; Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Refrigerated RBCs 0-14 days old

Standard, refrigerated RBC units stored up to 14 days

Group Type: ACTIVE_COMPARATOR

RBC units

Intervention Type: BIOLOGICAL

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.

Refrigerated RBCs 15-42 days old

Standard, refrigerated RBC units stored 15-42 days

Group Type: ACTIVE_COMPARATOR

RBC units

Intervention Type: BIOLOGICAL

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.

Frozen RBCs

RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.

Group Type: EXPERIMENTAL

RBC units

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Air Force

FED

Sponsor Role: collaborator

Armed Services Blood Program

UNKNOWN

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Martin A Schreiber, MD

Professor & Chief of Trauma

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Schreiber, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

002-01

Identifier Type: -

Identifier Source: org_study_id