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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03855722
Other study ID # RIPTRANS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 12, 2019
Est. completion date February 2042

Study information

Verified date March 2020
Source Helsinki University Central Hospital
Contact Ville Sallinen, MD, PhD
Phone +358-9-4711
Email ville.sallinen@helsinki.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 496
Est. completion date February 2042
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
RIPC
Remote Ischaemic Preconditioning
Sham-RIPC
Sham procedure

Locations

Country Name City State
Finland Helsinki University Hospital Helsinki

Sponsors (4)

Lead Sponsor Collaborator
Helsinki University Central Hospital Academy of Finland (funding), Finska Läkaresällskapet (funding), Helsinki University Hospital Research Funds (funding)

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory outcomes Kidney allograft miR-21 Measurement of reperfusion injury in blood and urine samples micro-RNA miR-21 peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Other Exploratory outcomes Kidney allograft miR-24 Measurement of reperfusion injury in blood and urine samples micro-RNA miR-24 peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Other Exploratory outcomes Kidney allograft NGAL Measurement of reperfusion injury in blood and urine samples neutrophil gelatinase associated lipocain NGAL peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Other Exploratory outcomes Kidney allograft KIM-1 Measurement of reperfusion injury in blood and urine samples kidney injury molecule -1 KIM-1 peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Other Exploratory outcomes Kidney allograft FABP-1 Measurement of reperfusion injury in blood and urine samples fatty acid binding protein -1 FABP-1 peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Other Exploratory outcomes Kidney allograft SLPI Measurement of reperfusion injury in blood and urine samples secretory leucocyte proteinase inhibitor SLPI peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion
Other Exploratory outcomes Liver allograft: Early allograft dysfunction Exploratory outcomes Liver allograft: Early allograft dysfunction according to Olthoff (Bil >100, INR 1.6 or more, ALT or AST > 2000 at 7th POD at 7 days
Other Exploratory outcomes Liver allograft: Highest ALT within 7th POD Exploratory outcomes Liver allograft: The highest ALT measurement within 7th POD within 7 days
Other Exploratory outcomes Liver allograft: Highest INR within 7th POD Exploratory outcomes Liver allograft: The highest INR measurement within 7th POD within 7 days
Other Exploratory outcomes Liver allograft: Highest Bil within 7th POD Exploratory outcomes Liver allograft: The highest Bil measurement within 7th POD within 7 days
Other Exploratory outcomes heart allografts: TnI Exploratory outcomes heart allografts: TnI measurement at 1 hour, 12 hours and 24 hours
Other Exploratory outcomes heart allografts: proBNP Exploratory outcomes heart allografts: (12/09/2019 BNP changed to proBNP because of changes in Helsinki University Hospital HUSlab laboratory protocols) at 1 day, 7 days, 14 days and 21 days
Other Exploratory outcomes heart allografts: crea Exploratory outcomes heart allografts: crea at 1 day, 7 days, 14 days and 21 days
Other Exploratory outcomes heart allografts: urea Exploratory outcomes heart allografts: urea at 1 day, 7 days, 14 days and 21 days
Other Exploratory outcomes heart allografts: eGFR Exploratory outcomes heart allografts: eGFR at 1 day, 7 days, 14 days and 21 days
Other Exploratory outcomes heart allografts: LVEF Exploratory outcomes heart allografts: left ventricle ejection fraction at 1 day, 7 days, 14 days and 21 days
Other Exploratory outcomes heart allografts: LV wall thickness Exploratory outcomes heart allografts: left ventricle wall thickness measurements at 1 day, 7 days, 14 days and 21 days
Other Exploratory outcomes heart allografts: tricuspidal leak Exploratory outcomes heart allografts: grading of the tricuspidal valve leak at 1 day, 7 days, 14 days and 21 days
Other Exploratory outcomes heart allografts: Ischaemia-reperfusion injury Exploratory outcomes heart allografts: The appearance of ischaemia-reperfusion injury in routine biopsies at 7 days, 14 days and 21 days
Other Exploratory outcomes heart allografts: fibrosis Exploratory outcomes heart allografts: The appearance of fibrosis associated factors in routine biopsies at 7 days, 14 days and 21 days
Other Exploratory outcomes heart allografts: long time follow-up of proBNP Exploratory outcomes heart allografts: long time follow-up of proBNP (12/09/2019 BNP changed to proBNP because of changes in Helsinki University Hospital HUSlab laboratory protocols) at 1 month, 3 months, 6 months, 12 months
Other Exploratory outcomes heart allografts: long time follow-up of LVEF Exploratory outcomes heart allografts: long time follow-up of left ventricle ejection fraction in cardiac ECHO at 1 month, 3 months, 6 months, 12 months
Other Exploratory outcomes heart allografts: CAD at 1 year Exploratory outcomes heart allografts: Coronary Artery Disease in coronary angiography at 1 year at 1 year
Other Exploratory outcomes heart allografts: MACE Exploratory outcomes heart allografts: Major Adverse Cardiac Events (including death because of cardiac cause, graft loss, primary allograft dysfunction, rejection classified as 2R or more) at 1 month, 3 months, 6 months, 12 months
Other Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury standardized P/F-ratio Severity of ischemia/reperfusion injury after transplantation: standardized P/F-ratio during mechanical ventilation at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Other Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: non-standardized P/F-ratio Severity of ischemia/reperfusion injury after transplantation: non-standardized P/F-ratio during mechanical ventilation at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Other Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: lactate Severity of ischemia/reperfusion injury after transplantation , plasma lactate, at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Other Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: CRP Severity of ischemia/reperfusion injury after transplantation: serum highly sensitive C-reactive protein at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Other Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: leuc Severity of ischemia/reperfusion injury after transplantation blood leukocyte count at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Other Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: neut Severity of ischemia/reperfusion injury after transplantation neutrophil count at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours
Other Exploratory outcomes lung allografts: FEV1 Exploratory outcomes lung allografts: FEV1 at 1 month, 3 months, 6 months, 12 months
Other Exploratory outcomes lung allografts: FVC Exploratory outcomes lung allografts: FVC at 1 month, 3 months, 6 months, 12 months
Other Exploratory outcomes lung allografts: chronic rejection Exploratory outcomes lung allografts: chronic rejection at 1 month, 3 months, 6 months, 12 months
Other Exploratory outcomes lung allografts: infections Exploratory outcomes lung allografts: infections after transplantation at 1 month, 3 months, 6 months, 12 months
Primary DGF Delayed graft function of kidney allografts defined as postoperative dialysis within 1 week from transplantation 7 days
Secondary Kidney allografts: eGFR Kidney allografts: estimated glomerular filtration rate at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Combined Pancreas-Kidney allografts: eGFR Combined Pancreas-Kidney allografts: estimated glomerular filtration rate at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Kidney allografts: BPAR Kidney allografts: Biopsy proven acute rejection within 1 year
Secondary Combined Pancreas-Kidney allografts: Kidney BPAR Combined Pancreas-Kidney allografts: Biopsy proven acute rejection in Kidney allograft within 1 year
Secondary Kidney allografts: graft survival Kidney allografts: time from transplantation to death, retransplantation or permanent dialysis at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Combined Pancreas-Kidney allografts: kidney graft survival Combined Pancreas-Kidney allografts: time from transplantation to death, retransplantation of the kidney or permanent dialysis at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Kidney allografts: death-censored graft survival Kidney allografts: time from transplantation to retransplantation or permanent dialysis, death-censored at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Combined Pancreas-Kidney allografts: death-censored kidney graft survival Combined Pancreas-Kidney allografts: time from transplantation to retransplantation of the kidney or permanent dialysis, death-censored at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Liver allografts: MEAF-score at 3rd POD 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) 3rd post-operative day
Secondary Liver allografts: Postoperative biliary complications Liver allografts: Amount and type of postoperative biliary complications: stricture at anastomosis, bile leak, ischaemic type biliary lesions (ITBL) within 1 year
Secondary Liver allografts: Posttransplantation kidney injury Liver allografts: Posttransplantation kidney injury (acute kidney injury) according to ADQI (2010) criteria within 1 week, at 3 months, 1 year
Secondary Liver allografts: BPAR Liver allografts: Biopsy proven acute rejection within 1 year
Secondary Liver allografts: graft survival Liver allografts: graft survival: time from transplantation to death, retransplantation or explantation at 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Pancreas allografts: HbA1c Pancreas allografts: blood HbA1c measurement at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Pancreas allografts: Acute rejection Pancreas allografts: Either biopsy proven (allograft pancreas or duodenal biopsy) acute rejection or clinically treated suspected acute rejection within 1 year
Secondary Pancreas allografts: Pancreatic allograft survival Pancreas allografts: Time from transplantation to death, retransplantation, explantation or daily insulin dependance at 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Pancreas allografts: Death-censored Pancreatic allograft survival Pancreas allografts: Time from transplantation to retransplantation, explantation or daily insulin dependance, death-censored at 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Heart allograft: TnI at 6 hours Heart allograft: blood TnI measurement at 6 hours after transplantation at 6 hours
Secondary Heart allograft: proBNP 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) at 1 week
Secondary Heart allograft: Primary graft dysfunction Heart allograft: Primary graft dysfunction according to ISHLT (2014) within 24 hours after transplantation
Secondary Heart allograft: acute rejection Heart allograft: Biopsy proven or clinically treated acute rejection within 1 year
Secondary Heart allograft: Vasculopathy-free survival Heart allograft: Vasculopathy-free survival according to Mehra (2010) at 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Heart allograft: graft survival Heart allograft: time from transplantation to death, retransplantation or explantation at 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Lung allograft: Primary graft dysfunction Lung allograft: Primary graft dysfunction according to ISHLT within 72 hours
Secondary Lung allograft: Acute rejection Lung allograft: Biopsy proven or clinically treated acute rejection within 1 year
Secondary Lung allograft: CLAD-free survival Lung allograft: Chronic Lung Allograft Dysfunction (CLAD) free survival according to Verleden (2014) at 1 year, 2 year, 5 year, 10 year, and 20 year
Secondary Lung allograft: graft survival 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.) at 1, 2, 5, 10 and 20 year
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