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OpenTrials
Completed

NCT Number: NCT01197573

Enhancing Donated After Cardiac Death (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.

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Key information

Conditions

Liver Transplantation Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTPA Treatment

Drug

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

Other names: Alteplase

No TPA Treatment

Other

Standard of Care

Primary outcomes

  1. Delayed Kidney Graft Function

    Time frame: 3 months

  2. Number of Participants With Primary Liver Graft Nonfunction

    Time frame: 1 month

Secondary outcomes

  1. Number of Participants With Liver Ischemic-Type Biliary Strictures

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Official study title

Enhancing DCD Utilization With Thrombolytic Therapy

Important dates

Study start
2010
Primary completion
2015
Study completion
2018
First posted
Sep 9, 2010
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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