Clinical trial NCT03855722: Remote Ischaemic Preconditioning in Transplantation (RIPTRANS)
Official title: Remote Ischaemic Preconditioning in Transplantation (RIPTRANS) - A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transplant Dysfunction
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Finska Läkaresällskapet (funding)
name: Academy of Finland
name: Helsinki University Hospital Research Funds (funding)
First posted: 2019-02-27
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: DGF
timeFrame: 7 days
Secondary outcomes:
measure: Kidney allografts: eGFR
timeFrame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Combined Pancreas-Kidney allografts: eGFR
timeFrame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Kidney allografts: BPAR
timeFrame: within 1 year
measure: Combined Pancreas-Kidney allografts: Kidney BPAR
timeFrame: within 1 year
measure: Kidney allografts: graft survival
timeFrame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Combined Pancreas-Kidney allografts: kidney graft survival
timeFrame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Kidney allografts: death-censored graft survival
timeFrame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Combined Pancreas-Kidney allografts: death-censored kidney graft survival
timeFrame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Liver allografts: MEAF-score at 3rd POD
timeFrame: 3rd post-operative day
measure: Liver allografts: Postoperative biliary complications
timeFrame: within 1 year
measure: Liver allografts: Posttransplantation kidney injury
timeFrame: within 1 week, at 3 months, 1 year
measure: Liver allografts: BPAR
timeFrame: within 1 year
measure: Liver allografts: graft survival
timeFrame: at 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Pancreas allografts: HbA1c
timeFrame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Pancreas allografts: Acute rejection
timeFrame: within 1 year
measure: Pancreas allografts: Pancreatic allograft survival
timeFrame: at 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Pancreas allografts: Death-censored Pancreatic allograft survival
timeFrame: at 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Heart allograft: TnI at 6 hours
timeFrame: at 6 hours
measure: Heart allograft: proBNP at 1 week
timeFrame: at 1 week
measure: Heart allograft: Primary graft dysfunction
timeFrame: within 24 hours after transplantation
measure: Heart allograft: acute rejection
timeFrame: within 1 year
measure: Heart allograft: Vasculopathy-free survival
timeFrame: at 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Heart allograft: graft survival
timeFrame: at 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Lung allograft: Primary graft dysfunction
timeFrame: within 72 hours
measure: Lung allograft: Acute rejection
timeFrame: within 1 year
measure: Lung allograft: CLAD-free survival
timeFrame: at 1 year, 2 year, 5 year, 10 year, and 20 year
measure: Lung allograft: graft survival
timeFrame: at 1, 2, 5, 10 and 20 year
Other outcomes:
measure: Exploratory outcomes Kidney allograft miR-21
timeFrame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
measure: Exploratory outcomes Kidney allograft miR-24
timeFrame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
measure: Exploratory outcomes Kidney allograft NGAL
timeFrame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
measure: Exploratory outcomes Kidney allograft KIM-1
timeFrame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
measure: Exploratory outcomes Kidney allograft FABP-1
timeFrame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
measure: Exploratory outcomes Kidney allograft SLPI
timeFrame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
measure: Exploratory outcomes Liver allograft: Early allograft dysfunction
timeFrame: at 7 days
measure: Exploratory outcomes Liver allograft: Highest ALT within 7th POD
timeFrame: within 7 days
measure: Exploratory outcomes Liver allograft: Highest INR within 7th POD
timeFrame: within 7 days
measure: Exploratory outcomes Liver allograft: Highest Bil within 7th POD
timeFrame: within 7 days
measure: Exploratory outcomes heart allografts: TnI
timeFrame: at 1 hour, 12 hours and 24 hours
measure: Exploratory outcomes heart allografts: proBNP
timeFrame: at 1 day, 7 days, 14 days and 21 days
measure: Exploratory outcomes heart allografts: crea
timeFrame: at 1 day, 7 days, 14 days and 21 days
measure: Exploratory outcomes heart allografts: urea
timeFrame: at 1 day, 7 days, 14 days and 21 days
measure: Exploratory outcomes heart allografts: eGFR
timeFrame: at 1 day, 7 days, 14 days and 21 days
measure: Exploratory outcomes heart allografts: LVEF
timeFrame: at 1 day, 7 days, 14 days and 21 days
measure: Exploratory outcomes heart allografts: LV wall thickness
timeFrame: at 1 day, 7 days, 14 days and 21 days
measure: Exploratory outcomes heart allografts: tricuspidal leak
timeFrame: at 1 day, 7 days, 14 days and 21 days
measure: Exploratory outcomes heart allografts: Ischaemia-reperfusion injury
timeFrame: at 7 days, 14 days and 21 days
measure: Exploratory outcomes heart allografts: fibrosis
timeFrame: at 7 days, 14 days and 21 days
measure: Exploratory outcomes heart allografts: long time follow-up of proBNP
timeFrame: at 1 month, 3 months, 6 months, 12 months
measure: Exploratory outcomes heart allografts: long time follow-up of LVEF
timeFrame: at 1 month, 3 months, 6 months, 12 months
measure: Exploratory outcomes heart allografts: CAD at 1 year
timeFrame: at 1 year
measure: Exploratory outcomes heart allografts: MACE
timeFrame: at 1 month, 3 months, 6 months, 12 months
measure: Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury standardized P/F-ratio
timeFrame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
measure: Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: non-standardized P/F-ratio
timeFrame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
measure: Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: lactate
timeFrame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
measure: Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: CRP
timeFrame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
measure: Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: leuc
timeFrame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
measure: Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: neut
timeFrame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
measure: Exploratory outcomes lung allografts: FEV1
timeFrame: at 1 month, 3 months, 6 months, 12 months
measure: Exploratory outcomes lung allografts: FVC
timeFrame: at 1 month, 3 months, 6 months, 12 months
measure: Exploratory outcomes lung allografts: chronic rejection
timeFrame: at 1 month, 3 months, 6 months, 12 months
measure: Exploratory outcomes lung allografts: infections
timeFrame: at 1 month, 3 months, 6 months, 12 months
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Aki Uutela, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Ville Sallinen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Marko Lempinen, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.