N/A
N=103
Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy
Liver Transplantation · Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT01197573 ↗Enrolled (actual)
103
Serious AEs
8.7%
Results posted
Aug 2018
Primary outcome: Primary: Delayed Kidney Graft Function — 5; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rTPA Treatment (Drug); No TPA Treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delayed Kidney Graft Function |
5; 7 | — |
| PRIMARY Number of Participants With Primary Liver Graft Nonfunction |
2; 1 | — |
| SECONDARY Number of Participants With Liver Ischemic-Type Biliary Strictures |
0; 3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01197573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.