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Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy

Information source: The Cleveland Clinic
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Transplantation; Kidney Transplantation

Intervention: rTPA Treatment (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: The Cleveland Clinic

Official(s) and/or principal investigator(s):
Bijan Eghtesad, MD, Principal Investigator, Affiliation: The Cleveland Clinic

Overall contact:
Bijan Eghtesad, MD, Phone: 216-444-9898, Email: eghtesb@ccf.org

Summary

The waiting list for kidney and liver transplantation continues to increase in the United States, and therefore the need grows for additional donor organs. Utilization of organs donated after cardiac death (DCD) could be one way to increase organ availability, however there are risks associated with poorer clinical outcomes, including delayed graft function and in livers specifically, ischemic-type biliary strictures (ITBS). We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

Clinical Details

Official title: Enhancing DCD Utilization With Thrombolytic Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Delayed Kidney Graft Function

Primary Liver Graft Nonfunction

Secondary outcome:

Liver Ischemic-Type Biliary Strictures

Decreased Kidney Graft Function

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults aged 18 years and older

- Subjects willing/able to provide written consent

- Subjects willing/able to comply with study requirements

- Subjects who will receive a solitary organ transplant

Exclusion Criteria:

- Subjects requiring multi-organ transplants

- Women who are pregnant

- Subjects with current severe systemic infection

- Subjects with an active infection

Locations and Contacts

Bijan Eghtesad, MD, Phone: 216-444-9898, Email: eghtesb@ccf.org

Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Bijan Eghtesad, MD, Phone: 216-444-9898, Email: eghtesb@ccf.org
Bijan Eghtesad, MD, Principal Investigator
David Goldfarb, MD, Sub-Investigator

University Hospitals / Case medical Center, Cleveland, Ohio 44106, United States; Active, not recruiting

Additional Information

Starting date: April 2010
Last updated: February 12, 2014

Page last updated: August 20, 2015

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