Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 After life support is withdrawn, organs are retrieved immediately for transplantation.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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05462041
Study type Interventional
Source Cedars-Sinai Medical Center
Contact Shruti Shantharam
Phone 5627873255
Email shruti.shantharam@csmns.org
Status Recruiting
Phase N/A
Start date October 10, 2022
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03938324 - Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions N/A
Active, not recruiting NCT05194514 - Trial to Compare the SherpaPak™ Device vs Cold Storage N/A
Completed NCT02729142 - Bone Microarchitecture in the Transplant Patient N/A
Completed NCT00213265 - Safety and Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Children Receiving Solid Organ Transplants Phase 3
Withdrawn NCT05157997 - Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail Phase 1
Not yet recruiting NCT05732922 - ORCHARD- Optimising Home Assessment of Rural Patients N/A
Recruiting NCT05595837 - Immune Registry for Organ Transplantation From COVID Positive Donors.
Completed NCT05194306 - PERTRIAL - Perla® Preservation Solution N/A
Completed NCT00367809 - Wellness Interventions After Transplant Study Phase 3
Recruiting NCT05884736 - Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant