DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors

Last updated: April 16, 2025
Sponsor: Cedars-Sinai Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Organ Transplant

Treatment

DBD Donor Heart Transplantation

DCD Donor Heart Transplantation

Clinical Study ID

NCT05462041
STUDY00002090
  • Ages > 18
  • All Genders

Study Summary

The purpose the research is to evaluate whether patients who receive a Donation after Circulatory Death (DCD) heart for cardiac transplantation using either normothermic regional perfusion (NRP) or direct procurement and perfusion (DPP) have similar outcomes as patients who receive Donation after Brain Death (DBD) heart using standard cold storage. The study will also evaluate whether DCD procured hearts have a meaningful impact on hearts available for transplantation at our center.

Eligibility Criteria

Inclusion

Recipient Inclusion Criteria:

  1. Subjects must be willing and be capable of understanding the purpose and risks ofthe study and must sign a statement of informed consent OR consent of a legallyauthorized representative of a cognitively impaired individual will be obtainedbefore the cognitively impaired individual may be included in research.

  2. Signed: 1) written informed consent document and 2) authorization to use anddisclose protected health information

  3. Male or female, aged 18 years of age or older listed for primary heart transplant

Exclusion

Recipient Exclusion Criteria:

  1. Prior history of cardiac transplantation

  2. Multi-organ transplant

  3. Current or planned participation in another interventional trial

  4. Recipient has any condition that, in the opinion of the Investigator, would makestudy participation unsafe or would interfere with the objectives of the study

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: DBD Donor Heart Transplantation
Phase:
Study Start date:
May 24, 2022
Estimated Completion Date:
December 31, 2025

Study Description

In the U.S., heart donation occurs after a person has been declared brain dead and is called a donor after brain death (DBD). In these patients, the heart continues to beat and pump blood throughout the body. After life support is withdrawn, organs are retrieved immediately for transplantation. This study will use hearts from donors after circulatory death (DCD) donors. DCD donors are those whose hearts have stopped beating and no longer pump blood. DCD hearts are not used as often for transplantation today in the U.S. because they may be further injured during traditional cold storage. In the US, donor hearts are currently mostly obtained from donors after brain death (DBD), although DCD donors are used for other donated organs, such as: lungs, kidneys, and livers.

This study will evaluate whether patients who receive a DCD heart transplant using either NRP or DPP have similar outcomes as patients who receive DBD hearts using standard cold storage. The study will also evaluate whether DCD procured hearts have a meaningful impact on hearts available for transplantation at our center. Ten (10) DCD donor heart recipients will be enrolled into the study intervention group, and approximately 30 DBD donor heart recipients will be enrolled into the control group.

Connect with a study center

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

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