Frozen Red Blood Cell Transfusions in Trauma Patients

January 16, 2020 updated by: Martin A Schreiber, MD, Oregon Health and Science University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States
        • University of Cincinnati
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Texas
      • Dallas, Texas, United States
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States
        • University of Texas Health Science Center at Houston
      • San Antonio, Texas, United States
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Refrigerated RBCs 0-14 days old
Standard, refrigerated RBC units stored up to 14 days
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.
Active Comparator: Refrigerated RBCs 15-42 days old
Standard, refrigerated RBC units stored 15-42 days
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.
Experimental: Frozen RBCs
RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tissue Oxygenation
Time Frame: 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.
Percentage of baseline (3 hours post transfusion compared to baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
2,3 DPG Levels After Transfusion
Time Frame: 12 hours post transfusion
2,3 DPG levels 12 hours after transfusion
12 hours post transfusion
Free Hemoglobin Levels After Transfusion
Time Frame: 12 hours after transfusion
Free hemoglobin levels 12 hours after transfusion
12 hours after transfusion
Haptoglobin Levels 12 Hours After Transfusion
Time Frame: 12 hours after transfusion
Haptoglobin levels after transfusion
12 hours after transfusion
Clinical Outcomes - Hospital Days
Time Frame: 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.
from time of randomization through hospital discharged, assessed up to 6 months
Clinical Outcomes - ICU Days
Time Frame: from time of randomization through hospital discharged, assessed up to 6 months
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
Time Frame: from time of randomization through hospital discharged, assessed up to 6 months
from time of randomization through hospital discharged, assessed up to 6 months
Number of Participants With Acute Renal Failure
Time Frame: from time of randomization through hospital discharged, assessed up to 6 months
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
Time Frame: from time of randomization through hospital discharged, assessed up to 6 months
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
Time Frame: from time of randomization through hospital discharged, assessed up to 6 months
Number of subjects who developed infections while hospitalized.
from time of randomization through hospital discharged, assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Air Force
Armed Services Blood Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 002-01

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