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Active Not Recruiting NCT05462041

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

Conditions: Organ Transplant

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Cedars-Sinai Medical Center

Location: Cedars Sinai Medical Center Los Angeles California

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

Recipient Inclusion Criteria: 1. 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. 2. Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information 3. Male or female, aged 18 years of age or older listed for primary heart transplant 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 make study participation unsafe or would interfere with the objectives of the study

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05462041). StuddyBuddy aggregates publicly available trial information.