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

Helsinki University Central Hospital1 site in 1 country496 target enrollmentMarch 12, 2019

ConditionsTransplant Dysfunction

Overview

Phase: N/A
Intervention: Not specified
Conditions: Transplant Dysfunction
Sponsor: Helsinki University Central Hospital
Enrollment: 496
Locations: 1
Primary Endpoint: DGF
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 12, 2019

End Date

February 2042

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Helsinki University Central Hospital

Responsible Party

Principal Investigator

Ville Sallinen

MD, PhD, Adj. Prof., Consultant

Helsinki University Central Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

DGF

Time Frame: 7 days

Delayed graft function of kidney allografts defined as postoperative dialysis within 1 week from transplantation

Secondary Outcomes

Combined Pancreas-Kidney allografts: kidney graft survival(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
Kidney allografts: BPAR(within 1 year)
Liver allografts: MEAF-score at 3rd POD(3rd post-operative day)
Pancreas allografts: Acute rejection(within 1 year)
Lung allograft: CLAD-free survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
Liver allografts: graft survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
Pancreas allografts: Death-censored Pancreatic allograft survival(at 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)
Pancreas allografts: HbA1c(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
Pancreas allografts: Pancreatic allograft survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
Heart allograft: proBNP at 1 week(at 1 week)
Heart allograft: Primary graft dysfunction(within 24 hours after transplantation)
Heart allograft: acute rejection(within 1 year)
Heart allograft: graft survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
Lung allograft: Primary graft dysfunction(within 72 hours)
Lung allograft: graft survival(at 1, 2, 5, 10 and 20 year)
Heart allograft: TnI at 6 hours(at 6 hours)
Kidney allografts: death-censored graft survival(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
Combined Pancreas-Kidney allografts: death-censored kidney graft survival(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year)
Liver allografts: Postoperative biliary complications(within 1 year)
Liver allografts: Posttransplantation kidney injury(within 1 week, at 3 months, 1 year)
Liver allografts: BPAR(within 1 year)
Kidney allografts: eGFR(at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 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)
Heart allograft: Vasculopathy-free survival(at 1 year, 2 year, 5 year, 10 year, and 20 year)
Lung allograft: Acute rejection(within 1 year)