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Organ Transplantation

Donor Heart Transplantation for Solid Organ Transplant

N/A

Recruiting

Led By Fardad Esmailian, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing whether hearts from people who die from circulatory death work as well as hearts from people who die from brain death, and if using them increases the number of hearts available for transplant.

Who is the study for?

This trial is for adults over 18 who need their first heart transplant and can understand the study's risks. They must sign consent forms to participate. People with a previous heart transplant, needing multiple organ transplants, or conditions that make the study unsafe are excluded.Check my eligibility

What is being tested?

The trial compares two ways of getting donor hearts: one from donors after circulatory death (DCD) using special techniques (NRP or DPP), and another from donors after brain death (DBD) with standard methods. It checks if DCD hearts work as well as DBD ones.See study design

What are the potential side effects?

While specific side effects aren't listed, receiving a donor heart involves risks like rejection, infection, and complications related to surgery and immunosuppressive medications used to prevent rejection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Assess the practical, financial and logistical viability of using NRP vs. DPP for the procurement of DCD donor hearts.

Trial Design

2Treatment groups

Experimental Treatment

Group I: DCD Donor Heart TransplantationExperimental Treatment1 Intervention

If the heart offer is from a DCD donor, the heart will be retrieved using one of two strategies: Normothermic Regional Perfusion (NRP) or Direct Procurement and Perfusion (DPP). NRP procedures will be used to procure all DCD hearts unless contraindicated or prohibited by the donor hospital. In the event the donor hospital does not allow NRP for cardiac organ procurement, or the target number of eight DCD transplants with NRP has been achieved, DPP with the Organ Care System (OCS) should be utilized.

Group II: DBD Donor Heart TransplantationExperimental Treatment1 Intervention

If the heart offer is from a DBD donor, the heart will be retrieved per standard of care.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

499 Previous Clinical Trials

164,827 Total Patients Enrolled

1 Trials studying Solid Organ Transplant

20 Patients Enrolled for Solid Organ Transplant

Fardad Esmailian, MDPrincipal InvestigatorCedars-Sinai Medical Center

1 Previous Clinical Trials

1,017 Total Patients Enrolled

Media Library

DCD Donor Heart Transplantation (Organ Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT05462041 — N/A

Solid Organ Transplant Research Study Groups: DCD Donor Heart Transplantation, DBD Donor Heart Transplantation

Solid Organ Transplant Clinical Trial 2023: DCD Donor Heart Transplantation Highlights & Side Effects. Trial Name: NCT05462041 — N/A

DCD Donor Heart Transplantation (Organ Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05462041 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in the research still available for interested subjects?

"The clinicaltrials.gov website reveals that this trial, which was initially published on September 19th 2022, is no longer in search of patients. Nonetheless, there are 97 other trials that are still open for enrollment at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Fardad Esmailian 2022. "DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05462041.