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

Overview

  • Study type

    Interventional
  • Study phase

    I/II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 13-005965
    NCT ID: NCT02094118
    Sponsor Protocol Number: 13-005965

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Daryl Kor, M.D.

Open for enrollment

Contact information:

Laurie Meade R.N.

(507)255-1829

Meade.Laurie@mayo.edu

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CLS-20118031

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