Active — Not RecruitingNot Applicable

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

United States30 participantsStarted 2022-05-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent OR consent of a legally authorized representative of a cognitively impaired individual will be obtained before the cognitively impaired individual may be included in research.
✓. Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
✓. Male or female, aged 18 years of age or older listed for primary heart transplant

Exclusion criteria

✕. Prior history of cardiac transplantation
✕. Multi-organ transplant
✕. Current or planned participation in another interventional trial
✕. Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study

What they're measuring

Evaluate the safety of utilizing DCD donor hearts as compared to DBD donor hearts for transplantation.

Timeframe: 30 days post-heart transplant

Trial details

NCT IDNCT05462041

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-31

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