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Recruiting NCT03855722

Remote Ischaemic Preconditioning in Transplantation (RIPTRANS)

No phase Interventional Transplant Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RIPC, Sham-RIPC.
Who it may be relevant to
Registry conditions: Transplant Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Remote Ischaemic Preconditioning in Transplantation (RIPTRANS) - A Prospective Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure RIPC
    Remote Ischaemic Preconditioning
  • Procedure Sham-RIPC
    Sham procedure

Primary outcome measures

  • DGF [Time frame: 7 days]
Secondary outcome measures (12)
  • Kidney allografts: eGFR [Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year]
  • Combined Pancreas-Kidney allografts: eGFR [Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year]
  • Kidney allografts: BPAR [Time frame: within 1 year]
  • Combined Pancreas-Kidney allografts: Kidney BPAR [Time frame: within 1 year]
  • Kidney allografts: graft survival [Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year]
  • Combined Pancreas-Kidney allografts: kidney graft survival [Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year]
  • Kidney allografts: death-censored graft survival [Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year]
  • Combined Pancreas-Kidney allografts: death-censored kidney graft survival [Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year]
  • Liver allografts: MEAF-score at 3rd POD [Time frame: 3rd post-operative day]
  • Liver allografts: Postoperative biliary complications [Time frame: within 1 year]
  • Liver allografts: Posttransplantation kidney injury [Time frame: within 1 week, at 3 months, 1 year]
  • Liver allografts: BPAR [Time frame: within 1 year]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Finland · 1 center
  • Helsinki University Hospital — Helsinki

Publications

  • Uutela A, Helantera I, Lemstrom K, Passov A, Syrjala S, Aberg F, Makisalo H, Nordin A, Lempinen M, Sallinen V; RIPTRANS Study Group collaborators. Randomised sham-controlled double-blind trial evaluating remote ischaemic preconditioning in solid organ transplantation: a study protocol for the RIPTRANS trial. BMJ Open. 2020 Nov 16;10(11):e038340. doi: 10.1136/bmjopen-2020-038340. PMID 33199419

Identifiers

NCT: NCT03855722 · RIPTRANS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗