Remote Ischaemic Preconditioning in Transplantation (RIPTRANS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

496 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-12

Study Completion Date

2042-02-28

Brief Summary

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Remote ischemic preconditioning (RIPC) is a concept where remotely induced ischemia produces protection against ischemia-reperfusion injury in a remote organ. RIPC has been studied extensively in animal models and heart surgery, but it's benefit in transplantation has been studied less. The primary aim of this study is to find out whether RIPC performed in a donor in donation after brain-death (DBD) could improve delayed graft function rate of kidney transplants.

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Detailed Description

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Conditions

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Transplant Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RIPC

RIPC will consist of setting a tourniquet to donor thigh and inflating it to 300mmHg four times 5 minutes with 5 minutes deflating in between each. RIPC-intervention will be performed twice: First after brain death and second time before procurement procedure.

Group Type EXPERIMENTAL

RIPC

Intervention Type PROCEDURE

Remote Ischaemic Preconditioning

Sham-RIPC

Sham-RIPC will consist of setting a tourniquet to donor thigh without inflating it and keeping it in place for 35 min. Sham-RIPC-intervention will be performed twice: First after brain death and second time before procurement procedure.

Group Type SHAM_COMPARATOR

Sham-RIPC

Intervention Type PROCEDURE

Sham procedure

Interventions

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RIPC

Remote Ischaemic Preconditioning

Intervention Type PROCEDURE

Sham-RIPC

Sham procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Brain-dead organ donor with a plan of harvesting at least one kidney

Exclusion Criteria

* Haemodynamically unstable donor
* Age below 18 years
* Planned organ recipients are recruited to another prospective trial, which prevents participation in this trial.

All organ recipients receiving organs (kidney, liver, pancreas-kidney, heart, lungs) from a randomized donor will be recruited providing that the recipient surgery is performed at Helsinki University Hospital, recipient is over 18 years old, and recipient gives written informed consent to participate in the trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No