Remote Ischemic Preconditioning In Abdominal Organ Transplantation (RIPCOT)

January 13, 2015 updated by: University of Medicine and Dentistry of New Jersey

Phase III Study of Efficacy of Remote Ischemic Preconditioning in Improving Outcomes in Organ Transplantation

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 after transplantation of kidneys, livers and pancreas? To test this hypothesis deceased organ donors will be randomized to receive either RIPC or No RIPC before organ recovery. RIPC will be induced in the operating room after commencement of procurement surgery. RIPC will be induced by tourniquet-induced occlusion of blood flow to the lower extremity for 10 minutes in each side, for a total duration of 20 minutes. The remainder of the organ recovery and organ preservation will be as per standard of practice. Recovered livers, kidneys and pancreas will be transplanted into allocated recipients. Transplantation and patient management after transplantation will be as per standard of practice.

Organ-specific function and cell injury parameters will be utilized to assess the early postoperative outcomes of individual organs and recipients. Long term outcomes will be assessed by graft and recipient survival.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 in acute care hospitals in the donor service area of the New Jersey Organ and Tissue Sharing Network (NJTO).

I.B. Exclusion criteria

  1. Tissue only donors
  2. Age < 5 years

  3. When it is known before organ recovery that both kidneys will be leaving New JerseyIntervention: RIPC will be induced by inflation of a tourniquet around the upper thigh to 200 mm of Hg for a period of 10 minutes. After tourniquet deflation on one side, a similar procedure will be followed immediately on the opposite side. Thus, a total period of 20 minutes of lower extremity vascular occlusion will be utilized to induce RIPC. In instances of severe trauma to one lower extremity precluding tourniquet use, we will employ two cycles of 10 minutes of tourniquet occlusion in the non-traumatized lower extremity with 10 min of reperfusion in between. RIPC will be induced after commencement of procurement surgery but completed 30-45 min before circulatory arrest and initiation of organ perfusion.

    Additionally, liver biopsies (a wedge measuring 0.75 x 0.75 cm and a Tru-cut needle biopsy from the right lobe) are performed in as soon as the abdomen is opened. A wedge (1 x 0.3 cm) kidney biopsy is performed in all donors after kidney recovery but before packing the organs. All biopsies except kidney biopsies in donors aged < 50 years, are as per standard of care. The remainder of organ recovery, organ packaging and preservation are as per standard of practice. All kidneys recovered from donors classified as Extended Criteria Donors (donor age > 60 years or age 50-59 years with two of the following three criteria- cerebrovascular cause of death, a history of hypertension, terminal serum creatinine > 1.5 mg/dL) are routinely perfused ex-vivo in a pulsatile hypothermic perfusion apparatus until transplantation.

    . 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

  4. Deceased donors in whom a decision is made not to recover both kidneys (severe kidney disease, renal failure, etc)
  5. Severe trauma to both lower extremities precluding induction of RIPC

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07101
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Exclusion Criteria:

  • Live donor recipients
  • Recipients of livers imported from outside NJTO
  • Recipients of deceased donor livers from donors < 5 years of age
  • Recipients of livers from deceased donors not enrolled in the study due to logistical reasons

RECIPIENTS - PANCREAS

Inclusion Criteria:

  • All recipients of solid organ pancreas (isolated pancreas transplant or combined kidney pancreas transplant) from deceased donors enrolled in this study and who receive their transplants at one of the four pancreas transplant centers in New Jersey, HUH, SBMC, RWJUH and OLMC. NBIMC and UH do not perform pancreas transplantation

Exclusion Criteria

  • Islet cell transplant recipients
  • Recipients of deceased donor whole organ pancreas imported from outside NJ
  • Recipients of pancreas from deceased donors < 5 years of age
  • Recipients of pancreata from deceased donors not enrolled in the study due to logistical reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No RIPC Group
This group is the control group or the comparator group with RIPC
Experimental: RIPC Group
In this group deceased donors will receive Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet of the lower limb prior to organ recovery.
Procedure: RIPC by Inflation of Pneumatic Tourniquet
Pneumatic tourniquets will be placed on both lower extremities in all deceased donor subjects. In the RIPC group the tourniquets will be inflated sequentially for 10 min each followed by deflation, approximately, 30-60 min prior to aortic crossclamping and organ perfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organ Recovery
Time Frame: 1 week
Organs Recovered and Transplanted per donor
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Investigators

  • Principal Investigator: Baburao Koneru, M.D., UMDNJ-New Jersey Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120080212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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