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Completed

NCT Number: NCT01038557

Frozen Red Blood Cell Transfusions 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

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Key information

Conditions

Blood Loss Anemia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma Wounds and Injuries

Age range

15 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati, Cincinnati, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RBC units

Biological

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 outcomes

  1. 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.

Secondary outcomes

  1. 2,3 DPG Levels After Transfusion

    Time frame: 12 hours post transfusion

    2,3 DPG levels 12 hours after transfusion

  2. Free Hemoglobin Levels After Transfusion

    Time frame: 12 hours after transfusion

    Free hemoglobin levels 12 hours after transfusion

  3. Haptoglobin Levels 12 Hours After Transfusion

    Time frame: 12 hours after transfusion

    Haptoglobin levels after transfusion

  4. 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.

  5. 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

  6. Clinical Outcomes - Ventilator Days

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

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Armed Services Blood Program
  • United States Air Force

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 24, 2009
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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