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

July 31, 2018 updated by: Bijan Eghtesad, MD, The Cleveland Clinic

Enhancing DCD Utilization With Thrombolytic Therapy

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospitals / Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard DCD liver transplant
Standard method of liver transplant utilizing a DCD organ
Other: No TPA Treatment
Standard of Care
Active Comparator: rTPA Treatment Liver Transplant
Ex-vivo treatment of liver 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 Names:
  • Alteplase
Active Comparator: Standard DCD kidney transplant
Standard method of kidney transplant utilizing a DCD organ
Other: No TPA Treatment
Standard of Care
Active Comparator: rTPA Treatment Kidney Transplant
Ex-vivo treatment of 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 Names:
  • Alteplase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Delayed Kidney Graft Function
Time Frame: 3 months
3 months
Number of Participants With Primary Liver Graft Nonfunction
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Liver Ischemic-Type Biliary Strictures
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Health Resources and Services Administration (HRSA)

Investigators

  • Principal Investigator: Bijan Eghtesad, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCIRB: 10-365
  • R38OT15491 (Other Grant/Funding Number: HRSA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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