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Frozen Red Blood Cell Transfusions in Trauma Patients

Primary Purpose

Blood Loss, Anemia, Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RBC units
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring frozen, red blood cells, transfusion, trauma

Eligibility Criteria

15 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cincinnati
  • Oregon Health & Science University
  • University of Texas Southwestern Medical Center
  • University of Texas Health Science Center at Houston
  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Refrigerated RBCs 0-14 days old

Refrigerated RBCs 15-42 days old

Frozen RBCs

Arm Description

Standard, refrigerated RBC units stored up to 14 days

Standard, refrigerated RBC units stored 15-42 days

RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.

Outcomes

Primary Outcome Measures

Tissue Oxygenation
Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2009
Last Updated
January 16, 2020
Sponsor
Oregon Health and Science University
Collaborators
United States Air Force, Armed Services Blood Program
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1. Study Identification

Unique Protocol Identification Number
NCT01038557
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
United States Air Force, Armed Services Blood Program

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Anemia, Trauma
Keywords
frozen, red blood cells, transfusion, trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Refrigerated RBCs 0-14 days old
Arm Type
Active Comparator
Arm Description
Standard, refrigerated RBC units stored up to 14 days
Arm Title
Refrigerated RBCs 15-42 days old
Arm Type
Active Comparator
Arm Description
Standard, refrigerated RBC units stored 15-42 days
Arm Title
Frozen RBCs
Arm Type
Experimental
Arm Description
RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.
Intervention Type
Biological
Intervention Name(s)
RBC units
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tissue Oxygenation
Description
Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.
Time Frame
Percentage of baseline (3 hours post transfusion compared to baseline)
Secondary Outcome Measure Information:
Title
2,3 DPG Levels After Transfusion
Description
2,3 DPG levels 12 hours after transfusion
Time Frame
12 hours post transfusion
Title
Free Hemoglobin Levels After Transfusion
Description
Free hemoglobin levels 12 hours after transfusion
Time Frame
12 hours after transfusion
Title
Haptoglobin Levels 12 Hours After Transfusion
Description
Haptoglobin levels after transfusion
Time Frame
12 hours after transfusion
Title
Clinical Outcomes - Hospital Days
Description
Clinical outcomes - Number of days admitted to the hospital within a 6 month window.
Time Frame
from time of randomization through hospital discharged, assessed up to 6 months
Title
Clinical Outcomes - ICU Days
Description
Number of days admitted to the ICU during hospital admission
Time Frame
from time of randomization through hospital discharged, assessed up to 6 months
Title
Clinical Outcomes - Ventilator Days
Time Frame
from time of randomization through hospital discharged, assessed up to 6 months
Title
Number of Participants With Acute Renal Failure
Description
Number of participants who developed acute renal failure while hospitalized.
Time Frame
from time of randomization through hospital discharged, assessed up to 6 months
Title
Clinical Outcomes - Acute Respiratory Distress Syndrome
Description
Number of subjects who developed acute respiratory distress syndrome while hospitalized.
Time Frame
from time of randomization through hospital discharged, assessed up to 6 months
Title
Clinical Outcomes - Infections
Description
Number of subjects who developed infections while hospitalized.
Time Frame
from time of randomization through hospital discharged, assessed up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schreiber, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

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Frozen Red Blood Cell Transfusions in Trauma Patients

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