Frozen Red Blood Cell Transfusions in Trauma Patients

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038557
• Other study ID #: 002-01
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: May 2014

Study information

• Verified date: January 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 100 Years

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

Related Conditions & MeSH terms

• Anemia
• Blood Loss
• Trauma
• Wounds and Injuries

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	Armed Services Blood Program, United States Air Force

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2,3 DPG Levels After Transfusion	2,3 DPG levels 12 hours after transfusion	12 hours post transfusion
Secondary	Free Hemoglobin Levels After Transfusion	Free hemoglobin levels 12 hours after transfusion	12 hours after transfusion
Secondary	Haptoglobin Levels 12 Hours After Transfusion	Haptoglobin levels after transfusion	12 hours after transfusion
Secondary	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
Secondary	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
Secondary	Clinical Outcomes - Ventilator Days		from time of randomization through hospital discharged, assessed up to 6 months
Secondary	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
Secondary	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
Secondary	Clinical Outcomes - Infections	Number of subjects who developed infections while hospitalized.	from time of randomization through hospital discharged, assessed up to 6 months