Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03204357
Status
Recruiting
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Conditions

  • Bleeding Postoperative
  • Cardiac Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Fresh Autologous whole Blood — OTHER
    Subjects randomized this arm will receive fresh autologous whole blood
  • Standard of Care Expectant management of bleeding — OTHER
    the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products

Study Details

Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate levels. The study design is a prospective randomized interventional trial of transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery.

Key Dates

Start date
Jan 24, 2022
Status verified
Nov 2024
Primary completion
Aug 31, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fresh Autologous whole blood transfusion
    The experimental group will have 15% of the estimated blood volume of autologous blood collected. This transfusion will be given at the end of the procedure.
  • Active Comparator: Standard of Care Expectant Management of bleeding
    the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products

Primary Outcome Measure

Estimated Blood Loss [ Time Frame: Within 24 hours after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Nathan Clendenen, MD MS
Nathan J Clendenen, MD MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Hospital· Aurora, CO

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