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

This study is currently recruiting participants. (see Contacts and Locations)
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, 2014
Last verified: February 2013

September 8, 2010
February 12, 2014
April 2010
May 2014   (final data collection date for primary outcome measure)
  • 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 ]
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 ] [ Designated as safety issue: No ]
  • Decreased Kidney Graft Function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy
Enhancing DCD Utilization With Thrombolytic Therapy

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
135
May 2014
May 2014   (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
Both
18 Years and older
No
Contact: Bijan Eghtesad, MD 216-444-9898 eghtesb@ccf.org
Contact: Mary Oldenburgh, BSN 216-444-8562 oldenbm@ccf.org
United States
 
NCT01197573
CCIRB: 10-365, R38OT15491
Yes
The Cleveland Clinic
The Cleveland Clinic
Health Resources and Services Administration (HRSA)
Principal Investigator: Bijan Eghtesad, MD The Cleveland Clinic
The Cleveland Clinic
February 2013

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