Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy
Enhancing DCD Utilization With Thrombolytic Therapy
2 other identifiers
interventional
103
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2010
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedResults Posted
Study results publicly available
August 28, 2018
CompletedAugust 28, 2018
July 1, 2018
5.5 years
September 8, 2010
June 12, 2018
July 31, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Delayed Kidney Graft Function
3 months
Number of Participants With Primary Liver Graft Nonfunction
1 month
Secondary Outcomes (1)
Number of Participants With Liver Ischemic-Type Biliary Strictures
1 year
Study Arms (4)
Standard DCD liver transplant
ACTIVE COMPARATORStandard method of liver transplant utilizing a DCD organ
rTPA Treatment Liver Transplant
ACTIVE COMPARATOREx-vivo treatment of liver donated after cardiac death (DCD) with rTPA
Standard DCD kidney transplant
ACTIVE COMPARATORStandard method of kidney transplant utilizing a DCD organ
rTPA Treatment Kidney Transplant
ACTIVE COMPARATOREx-vivo treatment of kidney donated after cardiac death (DCD) with rTPA
Interventions
Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects requiring multi-organ transplants
- Women who are pregnant
- Subjects with current severe systemic infection
- Subjects with an active infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospitals / Case medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bijan Eghtesad, MD
- Organization
- Cleveland Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Bijan Eghtesad, MD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- HPBT Staff Surgeon
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 9, 2010
Study Start
April 1, 2010
Primary Completion
October 1, 2015
Study Completion
May 1, 2018
Last Updated
August 28, 2018
Results First Posted
August 28, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share