Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05462041
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2022-07-14
Brief Title:
DCD IIT Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death DCD Donors
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death DCD Donors Compared to Donor Hearts From Donation After Brain Death DBD Donors A Single Center Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
In the US 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brain death DBD In these patients the heart continues to beat and pump blood throughout the body After life support is withdrawn organs are retrieved immediately for transplantation This study will use hearts from donors after circulatory death DCD donors DCD donors are those whose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 US 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None