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

This study is currently recruiting participants.
Verified February 2013 by The Cleveland Clinic
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01197573
First received: September 8, 2010
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Liver Transplantation
Kidney Transplantation
 Drug: rTPA Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancing DCD Utilization With Thrombolytic Therapy

Resource links provided by NLM:

Drug Information available for: Alteplase
U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Delayed Kidney Graft Function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Primary Liver Graft Nonfunction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Liver Ischemic-Type Biliary Strictures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Decreased Kidney Graft Function [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: April 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197573

Contacts
Contact: Bijan Eghtesad, MD 216-444-9898 eghtesb@ccf.org
Contact: Ricki Englehaupt, BSN 216-445-0063 englehr@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Bijan Eghtesad, MD     216-444-9898     eghtesb@ccf.org    
Principal Investigator: Bijan Eghtesad, MD            
Sub-Investigator: David Goldfarb, MD            
University Hospitals / Case medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: James Schulak, MD     216-844-0307     James.Schulak@UHhospitals.org    
Principal Investigator: James Schulak, MD            
Sponsors and Collaborators
The Cleveland Clinic
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Bijan Eghtesad, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01197573     History of Changes
Other Study ID Numbers: CCIRB: 10-365, R38OT15491
Study First Received: September 8, 2010
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013