RECRUITING

Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.

Quick Facts

Study Start:2022-01-24
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03204357

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult subjects aged 18 to 90
  2. 2. Able to provide informed consent
  3. 3. Willing to accept autologous or allogenic blood transfusion
  4. 4. Scheduled for elective cardiac surgery with cardiopulmonary bypass
  1. 1. Pre-operative administration of allogenic blood bank products in the previous 3 months
  2. 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. 3. Significant active infection or sepsis defined by positive blood culture or positive wound culture
  4. 4. Hemoglobin less than 7 g/dl

Contacts and Locations

Study Contact

Nathan J Clendenen, M.D.
CONTACT
720-848-6709
nathan.clendenen@cuanschutz.edu
Nick Naughton, B.A
CONTACT
720-848-6709
nick.naughton@cuanschutz.edu

Principal Investigator

Nathan Clendenen, M.D.
PRINCIPAL_INVESTIGATOR
University of Colorado - School of Medicine

Study Locations (Sites)

University of Colorado Hospital
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Nathan Clendenen, M.D., PRINCIPAL_INVESTIGATOR, University of Colorado - School of Medicine

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

Study Start Date2022-01-24
Study Completion Date2026-09

Study Record Updates

Study Start Date2022-01-24
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Cardiac surgery

Additional Relevant MeSH Terms

  • Cardiac Disease
  • Bleeding Postoperative