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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2018-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Donor Simvastatin Treatment in Organ Transplantation

NCT01160978

Heart Failure Respiratory Failure Liver Failure +2 more

COMPLETED PHASE2/PHASE3

Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients

NCT06043531

Liver Transplant

RECRUITING NA

Home-Care Needs in Liver or Renal Transplantation Recipients and Their Spouses

NCT01380002

Liver Transplant Renal Transplant

UNKNOWN

Dexmedetomidine and Liver Transplantation

NCT03770130

Dexmedetomidine, Liver Transplantation, Allograft Function, Survival

COMPLETED EARLY_PHASE1

Effects of Dexmedetomidine on Microcirculation of Kidney Transplant Recipient

NCT02707809

Kidney Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Transplantation Kidney Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard DCD liver transplant

Standard method of liver transplant utilizing a DCD organ

Group Type ACTIVE_COMPARATOR

No TPA Treatment

Intervention Type OTHER

Standard of Care

rTPA Treatment Liver Transplant

Ex-vivo treatment of liver donated after cardiac death (DCD) with rTPA

Group Type ACTIVE_COMPARATOR

rTPA Treatment

Intervention Type DRUG

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

Standard DCD kidney transplant

Standard method of kidney transplant utilizing a DCD organ

Group Type ACTIVE_COMPARATOR

No TPA Treatment

Intervention Type OTHER

Standard of Care

rTPA Treatment Kidney Transplant

Ex-vivo treatment of kidney donated after cardiac death (DCD) with rTPA

Group Type ACTIVE_COMPARATOR

rTPA Treatment

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rTPA Treatment

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

Intervention Type DRUG

No TPA Treatment

Standard of Care

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Alteplase

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No