Frozen Red Blood Cell Transfusions in Trauma Patients

Study Overview
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Brief Summary
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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

Official Title
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Efficacy and Safety of Frozen Red Blood Cells for Transfusion in Trauma Patients

Conditions
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Blood Loss, Anemia, Trauma

Intervention / Treatment
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* Biological: RBC units


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Refrigerated RBCs 0-14 days old<br>Standard, refrigerated RBC units stored up to 14 days | Biological: RBC units<br>* 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.<br>|
| Active Comparator: Refrigerated RBCs 15-42 days old<br>Standard, refrigerated RBC units stored 15-42 days | Biological: RBC units<br>* 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.<br>|
| Experimental: Frozen RBCs<br>RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. | Biological: RBC units<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frozen, red blood cells, transfusion, trauma