Remote Ischaemic Preconditioning in Transplantation (RIPTRANS)
- Conditions
- Transplant Dysfunction
- Interventions
- Procedure: Sham-RIPCProcedure: RIPC
- Registration Number
- NCT03855722
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 496
- Brain-dead organ donor with a plan of harvesting at least one kidney
Donor
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham-RIPC Sham-RIPC 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. RIPC RIPC 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.
- Primary Outcome Measures
Name Time Method DGF 7 days Delayed graft function of kidney allografts defined as postoperative dialysis within 1 week from transplantation
- Secondary Outcome Measures
Name Time Method Kidney allografts: BPAR within 1 year Kidney allografts: Biopsy proven acute rejection
Combined Pancreas-Kidney allografts: kidney graft survival at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year Combined Pancreas-Kidney allografts: time from transplantation to death, retransplantation of the kidney or permanent dialysis
Liver allografts: MEAF-score at 3rd POD 3rd post-operative day Liver allografts: Model for Early Allograft Function Scoring (MEAF) (MEAF = (score ALTmax:3POD+ score INRmax:3POD+ score bilirubin3POD), score range 0 - 10, higher score indicates worse outcome)
Pancreas allografts: Acute rejection within 1 year Pancreas allografts: Either biopsy proven (allograft pancreas or duodenal biopsy) acute rejection or clinically treated suspected acute rejection
Lung allograft: CLAD-free survival at 1 year, 2 year, 5 year, 10 year, and 20 year Lung allograft: Chronic Lung Allograft Dysfunction (CLAD) free survival according to Verleden (2014)
Liver allografts: graft survival at 1 year, 2 year, 5 year, 10 year, and 20 year Liver allografts: graft survival: time from transplantation to death, retransplantation or explantation
Pancreas allografts: Death-censored Pancreatic allograft survival at 1 year, 2 year, 5 year, 10 year, and 20 year Pancreas allografts: Time from transplantation to retransplantation, explantation or daily insulin dependance, death-censored
Combined Pancreas-Kidney allografts: eGFR at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year Combined Pancreas-Kidney allografts: estimated glomerular filtration rate
Pancreas allografts: HbA1c at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year Pancreas allografts: blood HbA1c measurement
Pancreas allografts: Pancreatic allograft survival at 1 year, 2 year, 5 year, 10 year, and 20 year Pancreas allografts: Time from transplantation to death, retransplantation, explantation or daily insulin dependance
Heart allograft: proBNP at 1 week at 1 week Heart allograft: blood proBNP measurement at 1 week after transplantation (12/09/2019 BNP changed to proBNP because of changes in Helsinki University Hospital HUSlab laboratory protocols)
Heart allograft: Primary graft dysfunction within 24 hours after transplantation Heart allograft: Primary graft dysfunction according to ISHLT (2014)
Heart allograft: acute rejection within 1 year Heart allograft: Biopsy proven or clinically treated acute rejection
Heart allograft: graft survival at 1 year, 2 year, 5 year, 10 year, and 20 year Heart allograft: time from transplantation to death, retransplantation or explantation
Lung allograft: Primary graft dysfunction within 72 hours Lung allograft: Primary graft dysfunction according to ISHLT
Lung allograft: graft survival at 1, 2, 5, 10 and 20 year Lung allograft: time from transplantation to death, retransplantation or explantation (12/16/2019 secondary outcome measures for lung recipients redifined. Lung recipients recruitment started later than for other organs because of a conflicting trial which now has completed recruiting. Only four lung patients have thus far been included in the study and no results for lung recipients have been analyzed.)
Heart allograft: TnI at 6 hours at 6 hours Heart allograft: blood TnI measurement at 6 hours after transplantation
Kidney allografts: death-censored graft survival at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year Kidney allografts: time from transplantation to retransplantation or permanent dialysis, death-censored
Combined Pancreas-Kidney allografts: death-censored kidney graft survival at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year Combined Pancreas-Kidney allografts: time from transplantation to retransplantation of the kidney or permanent dialysis, death-censored
Liver allografts: Postoperative biliary complications within 1 year Liver allografts: Amount and type of postoperative biliary complications: stricture at anastomosis, bile leak, ischaemic type biliary lesions (ITBL)
Liver allografts: Posttransplantation kidney injury within 1 week, at 3 months, 1 year Liver allografts: Posttransplantation kidney injury (acute kidney injury) according to ADQI (2010) criteria
Liver allografts: BPAR within 1 year Liver allografts: Biopsy proven acute rejection
Kidney allografts: eGFR at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year Kidney allografts: estimated glomerular filtration rate
Combined Pancreas-Kidney allografts: Kidney BPAR within 1 year Combined Pancreas-Kidney allografts: Biopsy proven acute rejection in Kidney allograft
Kidney allografts: graft survival at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year Kidney allografts: time from transplantation to death, retransplantation or permanent dialysis
Heart allograft: Vasculopathy-free survival at 1 year, 2 year, 5 year, 10 year, and 20 year Heart allograft: Vasculopathy-free survival according to Mehra (2010)
Lung allograft: Acute rejection within 1 year Lung allograft: Biopsy proven or clinically treated acute rejection
Trial Locations
- Locations (1)
Helsinki University Hospital
🇫🇮Helsinki, Finland