Frozen Red Blood Cell Transfusions in Trauma Patients

Not Applicable

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Refrigerated RBCs 15-42 days old	RBC units	Standard, refrigerated RBC units stored 15-42 days
Refrigerated RBCs 0-14 days old	RBC units	Standard, refrigerated RBC units stored up to 14 days
Frozen RBCs	RBC units	RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (5): University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, 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
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States