Status:
COMPLETED
Remote Ischemic Preconditioning In Abdominal Organ Transplantation
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Conditions:
Kidney Disease
Liver Disease
Eligibility:
All Genders
5+ years
Phase:
PHASE3
Brief Summary
Does remote ischemic preconditioning (RIPC) induced by a brief period of occlusion of blood flow to the lower extremity prior to organ recovery in deceased donors, improve short and long term outcomes...
Detailed Description
Deceased organ donors and recipients of kidneys, livers and pancreata from the study donors comprise the study subjects. I. DONORS I. A. Inclusion Criteria All deceased organ donors aged \> 5 years ...
Eligibility Criteria
Inclusion
- All deceased organ donors aged \> 5 years in acute care hospitals in the donor service area of the New Jersey Organ and Tissue Sharing Network (NJTO).
- DONORS
Exclusion
- Tissue only donors
- Age \< 5 years
- When it is known before organ recovery that both kidneys will be leaving New Jersey. This may happen in a few instances either because of excellent tissue match with recipients outside New Jersey or in high risk behavior donors where all NJ kidney transplant centers have declined donor kidneys before organ recovery
- Deceased donors in whom a decision is made not to recover both kidneys (severe kidney disease, renal failure, etc)
- Severe trauma to both lower extremities precluding induction of RIPC
- RECIPIENTS - KIDNEY
- Inclusion Criteria:
- Patients who receive a kidney from an enrolled donor at one of the five kidney transplant centers in New Jersey, HUH, NBIMC, SBMC, RWJUH and OLMC. No kidney recipients will be enrolled at UH because UH does not perform isolated kidney transplantation.
- Exclusion Criteria :
- All live donor kidney transplants performed at participating kidney transplant centers
- Recipients of deceased donor kidneys imported from outside NJTO
- Recipients of kidneys from deceased donors \< 5 years of age
- Recipients of combined liver and kidney transplantation, which are performed only at UH and OLMC. The numbers of such transplants are very few per year (\<5). Also, the clinical and pathophysiological issues are different from those requiring isolated kidney transplantation
- Recipients of en bloc (both kidneys together into one recipient) kidney transplantation from study donors. It is anticipated that such instances will be very few per year (\<5)
- Recipients of kidneys from deceased donors not enrolled in the study due to logistical reasons.
- RECIPIENTS - LIVER
- Inclusion Criteria:
- All recipients of livers from deceased donors enrolled in this study and who receive their transplants at either of the two liver transplant centers in New Jersey, UH or OLMC.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00975702
Start Date
April 1 2009
End Date
June 1 2014
Last Update
January 14 2015
Active Locations (1)
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1
University Hospital
Newark, New Jersey, United States, 07101