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

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ClinicalTrials.gov Identifier: NCT01197573
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Bijan Eghtesad, MD, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Kidney Transplantation Drug: rTPA Treatment Other: No TPA Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing DCD Utilization With Thrombolytic Therapy
Study Start Date : April 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

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 Name: 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 Name: Alteplase




Primary Outcome Measures :
  1. Delayed Kidney Graft Function [ Time Frame: 3 months ]
  2. Number of Participants With Primary Liver Graft Nonfunction [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Number of Participants With Liver Ischemic-Type Biliary Strictures [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197573


Locations
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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
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Principal Investigator: Bijan Eghtesad, MD The Cleveland Clinic
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Responsible Party: Bijan Eghtesad, MD, HPBT Staff Surgeon, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01197573    
Other Study ID Numbers: CCIRB: 10-365
R38OT15491 ( Other Grant/Funding Number: HRSA )
First Posted: September 9, 2010    Key Record Dates
Results First Posted: August 28, 2018
Last Update Posted: August 28, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action