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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
September 8, 2010
March 25, 2017
April 2010
December 2017   (Final data collection date for primary outcome measure)
  • Delayed Kidney Graft Function [ Time Frame: 3 months ]
  • Primary Liver Graft Nonfunction [ Time Frame: 1 month ]
Same as current
Complete list of historical versions of study NCT01197573 on ClinicalTrials.gov Archive Site
  • Liver Ischemic-Type Biliary Strictures [ Time Frame: 1 year ]
  • Decreased Kidney Graft Function [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Liver Transplantation
  • Kidney Transplantation
Drug: rTPA Treatment
Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation
Other Name: Alteplase
  • 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
    Intervention: Drug: rTPA Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2017
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01197573
CCIRB: 10-365
R38OT15491 ( Other Grant/Funding Number: HRSA )
Yes
Not Provided
Plan to Share IPD: No
Bijan Eghtesad, MD, The Cleveland Clinic
The Cleveland Clinic
Health Resources and Services Administration (HRSA)
Principal Investigator: Bijan Eghtesad, MD The Cleveland Clinic
The Cleveland Clinic
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP