RECRUITING

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

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

TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.

Official Title

An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery

Quick Facts

Study Start:2021-11-01
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04754022

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥18 and ≤65 years of age
  2. 2. Planned cardiac surgery using cardiopulmonary bypass
  3. 3. Informed consent obtained
  4. 4. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more
  1. 1. Patients who refuse participation
  2. 2. Patients who are unable to receive or who refuse blood products
  3. 3. Patients who are involved in a preoperative autologous pre-donation program
  4. 4. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
  5. 5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)

Contacts and Locations

Study Contact

David Mazer, MD
CONTACT
416-864-5825
David.Mazer@unityhealth.to

Principal Investigator

David Mazer, MD
PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Nadine Shehata, MD
PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL

Study Locations (Sites)

Maine Medical Center
Portland, Maine, 04102
United States
The Cooper Health System
Camden, New Jersey, 08103
United States
Columbia University
New York, New York, 10032
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Unity Health Toronto

  • David Mazer, MD, PRINCIPAL_INVESTIGATOR, Unity Health Toronto
  • Nadine Shehata, MD, PRINCIPAL_INVESTIGATOR, MOUNT SINAI HOSPITAL

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 Date2021-11-01
Study Completion Date2026-06

Study Record Updates

Study Start Date2021-11-01
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Cardiac Surgery
  • Transfusion

Additional Relevant MeSH Terms

  • Disorder
  • Heart
  • Postoperative
  • Cardiac Surgery