Clinical trial NCT01038557: Frozen Red Blood Cell Transfusions in Trauma Patients
Official title: Efficacy and Safety of Frozen Red Blood Cells for Transfusion in Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss
Anemia
Trauma
Keywords: frozen
red blood cells
transfusion
trauma
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: United States Air Force
name: Armed Services Blood Program
First posted: 2009-12-24
Enrollment: 254
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Tissue Oxygenation
timeFrame: Percentage of baseline (3 hours post transfusion compared to baseline)
Secondary outcomes:
measure: 2,3 DPG Levels After Transfusion
timeFrame: 12 hours post transfusion
measure: Free Hemoglobin Levels After Transfusion
timeFrame: 12 hours after transfusion
measure: Haptoglobin Levels 12 Hours After Transfusion
timeFrame: 12 hours after transfusion
measure: Clinical Outcomes - Hospital Days
timeFrame: from time of randomization through hospital discharged, assessed up to 6 months
measure: Clinical Outcomes - ICU Days
timeFrame: from time of randomization through hospital discharged, assessed up to 6 months
measure: Clinical Outcomes - Ventilator Days
timeFrame: from time of randomization through hospital discharged, assessed up to 6 months
measure: Number of Participants With Acute Renal Failure
timeFrame: from time of randomization through hospital discharged, assessed up to 6 months
measure: Clinical Outcomes - Acute Respiratory Distress Syndrome
timeFrame: from time of randomization through hospital discharged, assessed up to 6 months
measure: Clinical Outcomes - Infections
timeFrame: from time of randomization through hospital discharged, assessed up to 6 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Oregon Health and Science University
name: Martin Schreiber, MD
role: PRINCIPAL_INVESTIGATOR
References: