NCT01038557

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. 1.the transfused red blood cells' ability to delivery oxygen to the tissues
  2. 2.differences in biochemical markers in subjects and units transfused, and
  3. 3.how the subject's internal organs are working and if they develop any infections

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

January 28, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

4.3 years

First QC Date

December 23, 2009

Results QC Date

July 2, 2019

Last Update Submit

January 16, 2020

Conditions

Blood LossAnemiaTrauma

Keywords

frozenred blood cellstransfusiontrauma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 2,3 DPG Levels After Transfusion

    12 hours post transfusion

  • Free Hemoglobin Levels After Transfusion

    12 hours after transfusion

  • Haptoglobin Levels 12 Hours After Transfusion

    12 hours after transfusion

  • Clinical Outcomes - Hospital Days

    from time of randomization through hospital discharged, assessed up to 6 months

  • Clinical Outcomes - ICU Days

    from time of randomization through hospital discharged, assessed up to 6 months

  • +4 more secondary outcomes

Study Arms (3)

Refrigerated RBCs 0-14 days old

ACTIVE COMPARATOR

Standard, refrigerated RBC units stored up to 14 days

Biological: RBC units

Refrigerated RBCs 15-42 days old

ACTIVE COMPARATOR

Standard, refrigerated RBC units stored 15-42 days

Biological: RBC units

Frozen RBCs

EXPERIMENTAL

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

Biological: RBC units

Interventions

RBC unitsBIOLOGICAL

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.

Frozen RBCsRefrigerated RBCs 0-14 days oldRefrigerated RBCs 15-42 days old

Eligibility Criteria

Age15 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Cincinnati

Cincinnati, Ohio, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

HemorrhageAnemiaWounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Dr. Martin A. Schreiber
Organization
Oregon Health & Science University
schreibm@ohsu.edu
503-494-8324

Study Officials

  • Martin Schreiber, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Chief of Trauma

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 24, 2009

Study Start

January 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 28, 2020

Results First Posted

January 28, 2020

Record last verified: 2020-01

Locations

US(5)