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 FunctionPrimary Liver Graft Nonfunction
Secondary outcome: Liver Ischemic-Type Biliary StricturesDecreased 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
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