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

NCT01197573 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2018-08-28

Study results available
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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.

Conditions

  • Liver Transplantation
  • Kidney Transplantation

Interventions

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

Sponsors & Collaborators

  • Health Resources and Services Administration (HRSA)

    collaborator FED

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Bijan Eghtesad, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-10-31
Completion
2018-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197573 on ClinicalTrials.gov