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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Bijan Eghtesad, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01197573
First received: September 8, 2010
Last updated: March 25, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Liver Transplantation Kidney Transplantation Drug: rTPA Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing DCD Utilization With Thrombolytic Therapy

Resource links provided by NLM:


Further study details as provided by Bijan Eghtesad, MD, The Cleveland Clinic:

Primary Outcome Measures:
  • Delayed Kidney Graft Function [ Time Frame: 3 months ]
  • Primary Liver Graft Nonfunction [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Liver Ischemic-Type Biliary Strictures [ Time Frame: 1 year ]
  • Decreased Kidney Graft Function [ Time Frame: 1 year ]

Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard DCD liver or kidney transplant
Standard method of liver or kidney transplant utilizing a DCD organ
Active Comparator: rTPA Treatment
Ex-vivo treatment of liver or kidney donated after cardiac death (DCD)with rTPA
Drug: rTPA Treatment
Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation
Other Name: Alteplase

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197573

Locations
United States, Ohio
University Hospitals / Case medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Bijan Eghtesad, MD The Cleveland Clinic
  More Information

Responsible Party: Bijan Eghtesad, MD, HPBT Staff Surgeon, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01197573     History of Changes
Other Study ID Numbers: CCIRB: 10-365
R38OT15491 ( Other Grant/Funding Number: HRSA )
Study First Received: September 8, 2010
Last Updated: March 25, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2017