Remote Ischaemic Preconditioning in Transplantation (RIPTRANS)

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Transplant Dysfunction

Treatments: Procedure: Sham-RIPC; Procedure: RIPC

Study type: Interventional

Funder types: Other

Identifiers

NCT03855722

RIPTRANS

Details and patient eligibility

About

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.

Enrollment: 496 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Donor Inclusion Criteria:

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

Donor 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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496 participants in 2 patient groups

RIPC

Experimental group

Description:

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.

Treatment:

Procedure: RIPC

Sham-RIPC

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham-RIPC