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

Kidney Transplantation Clinical Trial

Official title:

Enhancing DCD Utilization With Thrombolytic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197573
• Other study ID #: CCIRB: 10-365
• Secondary ID: R38OT15491
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 2018
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation
• Liver Transplantation

Intervention

Drug:
• rTPA Treatment
Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation

Other:
• No TPA Treatment
Standard of Care

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals / Case medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed Kidney Graft Function		3 months
Primary	Number of Participants With Primary Liver Graft Nonfunction		1 month
Secondary	Number of Participants With Liver Ischemic-Type Biliary Strictures		1 year