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NCT05462041 · ClinicalTrials.gov registry record · NA
DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors
A NA study of Organ Transplant, sponsored by Cedars-Sinai Medical Center.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05462041: Active NA study of Organ Transplant, sponsored by Cedars-Sinai Medical Center.
NCT05462041 is a NA study of Organ Transplant that is active but no longer recruiting, run by Cedars-Sinai Medical Center. The registered enrollment target is 30 participants, below the 147-participant average among 3 other Organ Transplant trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05462041, a NA study of Organ Transplant, is active but no longer recruiting, sponsored by Cedars-Sinai Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary objective of this proposed research is to evaluate the safety of utilizing DCD donor hearts as compared to DBD donor hearts for transplantation HGRSAE (Heart Graft Related Serious Adverse Event) in the first 30 days post-transplan
Conditions Studied
Interventions
- OTHER DBD Donor Heart Transplantation
- DEVICE DCD Donor Heart Transplantation
Study Locations (1)
California
- Cedars Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-05-24 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the registry record for NCT05462041 still lists
NCT05462041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 147-participant average among 3 other Organ Transplant trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Organ Transplant appearing as the primary indexed condition, and to 2 interventions - of which DBD Donor Heart Transplantation is the first listed.
NCT05462041 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05462041 about?
NCT05462041 is a clinical study titled "DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors". 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 Br...
What is the current status of trial NCT05462041?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-05-24. Estimated completion is 2025-12-31.
What conditions does trial NCT05462041 study?
This clinical trial studies the following conditions: Organ Transplant.
What interventions are being tested in trial NCT05462041?
The interventions under investigation include: DBD Donor Heart Transplantation (OTHER), DCD Donor Heart Transplantation (DEVICE).
Who is sponsoring clinical trial NCT05462041?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05462041 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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