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Completed

NCT Number: NCT02094118

Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications

This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.

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Key information

Conditions

Blood Transfusion Complications Acute Lung Injury Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Transfusion Reaction Transfusion-Related Acute Lung Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age equal to or greater than 18 years of age.
  • Scheduled to have cardiac bypass surgery at Mayo Clinic in Rochester, Minnesota or Duke University Medical Center in Durham, North Carolina
  • At risk for needing at least 4 units of blood during/after surgery

Exclusion criteria

  • Emergency surgery
  • Immunoglobulin A (IgA) deficiency
  • History of severe recurrent transfusion reactions
  • Refusal to receive allogeneic blood products
  • Refusal to provide informed consent
  • Prevalent lung injury prior to randomization
  • Prevalent congestive heart failure prior to randomization
  • Expected hospital stay < 48 hours
  • Not anticipated to survive > 48 hours
  • Previously enrolled in this trial
  • No plan for placement of a pulmonary artery catheter
  • Use of home oxygen therapy
  • Complex RBC antibody profiles
  • Need for the use of irradiated RBCs

Treatment and study plan

Point-of-care washed red blood cell transfusion.

Biological

Standard of care red blood cell transfusion.

Biological

Primary outcomes

  1. Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.

    Time frame: 18 hours after the initiation of the first red blood cell transfusion.

    This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.

  2. Number of "Off-protocol" Transfusions

    Time frame: Day of surgery. Approximately 1 day.

    The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion.

  3. Change in Recipient Hemoglobin

    Time frame: Pre to 6 hours post transfusion

    Change in Hemoglobin from pre-transfusion to post-transfusion

  4. Change in Recipient Cell Free Hemoglobin(CFH)

    Time frame: Pre transfusion until study day 5 or hospital discharge, approximately 5 days

    Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion

  5. Change in Haptoglobin

    Time frame: Pre transfusion to study day 5 or hospital discharge, approximately 5 days

    Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion

Secondary outcomes

  1. Duration of Mechanical Ventilation

    Time frame: Up to hospital day 28, or discharge, whichever comes first

    Number of hours subject received mechanical ventilation.

  2. Duration of Oxygen Supplementation

    Time frame: Up to day 28, or hospital discharge, whichever comes first

    Number of hours subjects received supplemental oxygen.

  3. Sequential Organ Failure Assessment (SOFA) Score

    Time frame: Through postoperative day 5.

    Worst SOFA score between Day 1 and Day 5. SOFA scores range from 0-24 with 0 meaning no organ dysfunction and 24 means severe dysfunction of all organ systems evaluated. Each of 6 organ systems are scored on a 0-4 scale with the cumulative score being the total SOFA score.

  4. Hospital Length of Stay

    Time frame: Up to day 28

    Number of days subject remained in the hospital following their surgical procedure. If the number of days the subject remained in the hospital exceeded 28, a value of 28 is assigned.

  5. Post Transfusion Respiratory Complications.

    Time frame: Up to day 28

    Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Duke University
  • Vitalant Research Institute

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2014
Registry last updated
Apr 6, 2021

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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