Frozen Red Blood Cell Transfusions in Trauma Patients

Not Applicable

Completed

• Conditions: Blood Loss; Anemia; Trauma

• Registration Number: NCT01038557
• Lead Sponsor: Oregon Health and Science University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Study Start: 2010-01
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2019-07-02
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-16
• Last Update Submitted: 2020-01-16
• Results First Posted: 2020-01-28
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (5)

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