Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass
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.
Conditions:
🦠 Cardiac Disease 🦠 Bleeding Postoperative
🗓️ Study Start (Actual) 24 January 2022
🗓️ Primary Completion (Estimated) August 2025
✅ Study Completion (Estimated) September 2026
👥 Enrollment (Estimated) 70
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Aurora, Colorado, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Adult subjects aged 18 to 90
    • 2. Able to provide informed consent
    • 3. Willing to accept autologous or allogenic blood transfusion
    • 4. Scheduled for elective cardiac surgery with cardiopulmonary bypass

    Exclusion Criteria:

    • 1. Pre-operative administration of allogenic blood bank products in the previous 3 months
    • 2. Hemodynamically unstable defined as a systolic blood pressure less than 90 mmHg with a heart rate greater 100 or requiring intravenous vasopressor medications
    • 3. Significant active infection or sepsis defined by positive blood culture or positive wound culture
    • 4. Hemoglobin less than 7 g/dl
Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 27 June 2017
  • First Submitted that Met QC Criteria 29 June 2017
  • First Posted 2 July 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 March 2024
  • Last Update Posted 21 March 2024
  • Last Verified March 2024