Remote Ischaemic Preconditioning in Transplantation (RIPTRANS)
1 other identifier
interventional
496
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2019
CompletedFirst Posted
Study publicly available on registry
February 27, 2019
CompletedStudy Start
First participant enrolled
March 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2042
ExpectedMarch 10, 2020
March 1, 2020
3 years
February 11, 2019
March 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
DGF
Delayed graft function of kidney allografts defined as postoperative dialysis within 1 week from transplantation
7 days
Secondary Outcomes (27)
Kidney allografts: eGFR
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Combined Pancreas-Kidney allografts: eGFR
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Kidney allografts: BPAR
within 1 year
Combined Pancreas-Kidney allografts: Kidney BPAR
within 1 year
Kidney allografts: graft survival
at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
- +22 more secondary outcomes
Other Outcomes (34)
Exploratory outcomes Kidney allograft miR-21
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Exploratory outcomes Kidney allograft miR-24
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Exploratory outcomes Kidney allograft NGAL
peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
- +31 more other outcomes
Study Arms (2)
RIPC
EXPERIMENTALRIPC 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.
Sham-RIPC
SHAM COMPARATORSham-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.
Interventions
Eligibility Criteria
You may qualify if:
- Brain-dead organ donor with a plan of harvesting at least one kidney
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- Finska Läkaresällskapet (funding)collaborator
- Academy of Finlandcollaborator
- Helsinki University Hospital Research Funds (funding)collaborator
Study Sites (1)
Helsinki University Hospital
Helsinki, 00029, Finland
Related Publications (1)
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: 33199419DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Aki Uutela, MD
Helsinki University Central Hospital
- STUDY DIRECTOR
Ville Sallinen, MD, PhD
Helsinki University Central Hospital
- STUDY CHAIR
Marko Lempinen, MD, PhD
Helsinki University Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Adj. Prof., Consultant
Study Record Dates
First Submitted
February 11, 2019
First Posted
February 27, 2019
Study Start
March 12, 2019
Primary Completion
March 1, 2022
Study Completion (Estimated)
February 1, 2042
Last Updated
March 10, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
After the completion of the study the depersonalized data can be requested from the authors.