Viewing Study NCT01197573



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Last Modification Date: 2024-10-26 @ 10:24 AM
Study NCT ID: NCT01197573
Status: COMPLETED
Last Update Posted: 2018-08-28
First Post: 2010-09-08

Brief Title: Enhancing Donated After Cardiac Death DCD Utilization With Thrombolytic Therapy
Sponsor: The Cleveland Clinic
Organization: The Cleveland Clinic

Study Overview

Official Title: Enhancing DCD Utilization With Thrombolytic Therapy
Status: COMPLETED
Status Verified Date: 2018-07
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: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R38OT15491 OTHER_GRANT HRSA None