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NCT Number: NCT03855722

Remote Ischaemic Preconditioning in Transplantation (RIPTRANS)

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.

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Key information

Conditions

Transplant Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RIPC

Procedure

Remote Ischaemic Preconditioning

Sham-RIPC

Procedure

Sham procedure

Primary outcomes

  1. DGF

    Time frame: 7 days

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

Secondary outcomes

  1. Kidney allografts: eGFR

    Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year

    Kidney allografts: estimated glomerular filtration rate

  2. Combined Pancreas-Kidney allografts: eGFR

    Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year

    Combined Pancreas-Kidney allografts: estimated glomerular filtration rate

  3. Kidney allografts: BPAR

    Time frame: within 1 year

    Kidney allografts: Biopsy proven acute rejection

  4. Combined Pancreas-Kidney allografts: Kidney BPAR

    Time frame: within 1 year

    Combined Pancreas-Kidney allografts: Biopsy proven acute rejection in Kidney allograft

  5. Kidney allografts: graft survival

    Time frame: 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

  6. Combined Pancreas-Kidney allografts: kidney graft survival

    Time frame: 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

  7. Kidney allografts: death-censored graft survival

    Time frame: 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

  8. Combined Pancreas-Kidney allografts: death-censored kidney graft survival

    Time frame: 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

  9. Liver allografts: MEAF-score at 3rd POD

    Time frame: 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)

  10. Liver allografts: Postoperative biliary complications

    Time frame: within 1 year

    Liver allografts: Amount and type of postoperative biliary complications: stricture at anastomosis, bile leak, ischaemic type biliary lesions (ITBL)

  11. Liver allografts: Posttransplantation kidney injury

    Time frame: within 1 week, at 3 months, 1 year

    Liver allografts: Posttransplantation kidney injury (acute kidney injury) according to ADQI (2010) criteria

  12. Liver allografts: BPAR

    Time frame: within 1 year

    Liver allografts: Biopsy proven acute rejection

  13. Liver allografts: graft survival

    Time frame: at 1 year, 2 year, 5 year, 10 year, and 20 year

    Liver allografts: graft survival: time from transplantation to death, retransplantation or explantation

  14. Pancreas allografts: HbA1c

    Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year

    Pancreas allografts: blood HbA1c measurement

  15. Pancreas allografts: Acute rejection

    Time frame: within 1 year

    Pancreas allografts: Either biopsy proven (allograft pancreas or duodenal biopsy) acute rejection or clinically treated suspected acute rejection

  16. Pancreas allografts: Pancreatic allograft survival

    Time frame: 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

  17. Pancreas allografts: Death-censored Pancreatic allograft survival

    Time frame: 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

  18. Heart allograft: TnI at 6 hours

    Time frame: at 6 hours

    Heart allograft: blood TnI measurement at 6 hours after transplantation

  19. Heart allograft: proBNP at 1 week

    Time frame: 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)

  20. Heart allograft: Primary graft dysfunction

    Time frame: within 24 hours after transplantation

    Heart allograft: Primary graft dysfunction according to ISHLT (2014)

  21. Heart allograft: acute rejection

    Time frame: within 1 year

    Heart allograft: Biopsy proven or clinically treated acute rejection

  22. Heart allograft: Vasculopathy-free survival

    Time frame: at 1 year, 2 year, 5 year, 10 year, and 20 year

    Heart allograft: Vasculopathy-free survival according to Mehra (2010)

  23. Heart allograft: graft survival

    Time frame: at 1 year, 2 year, 5 year, 10 year, and 20 year

    Heart allograft: time from transplantation to death, retransplantation or explantation

  24. Lung allograft: Primary graft dysfunction

    Time frame: within 72 hours

    Lung allograft: Primary graft dysfunction according to ISHLT

  25. Lung allograft: Acute rejection

    Time frame: within 1 year

    Lung allograft: Biopsy proven or clinically treated acute rejection

  26. Lung allograft: CLAD-free survival

    Time frame: 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)

  27. Lung allograft: graft survival

    Time frame: 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.)

Other outcomes

  1. Exploratory outcomes Kidney allograft miR-21

    Time frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion

    Measurement of reperfusion injury in blood and urine samples micro-RNA miR-21

  2. Exploratory outcomes Kidney allograft miR-24

    Time frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion

    Measurement of reperfusion injury in blood and urine samples micro-RNA miR-24

  3. Exploratory outcomes Kidney allograft NGAL

    Time frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion

    Measurement of reperfusion injury in blood and urine samples neutrophil gelatinase associated lipocain NGAL

  4. Exploratory outcomes Kidney allograft KIM-1

    Time frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion

    Measurement of reperfusion injury in blood and urine samples kidney injury molecule -1 KIM-1

  5. Exploratory outcomes Kidney allograft FABP-1

    Time frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion

    Measurement of reperfusion injury in blood and urine samples fatty acid binding protein -1 FABP-1

  6. Exploratory outcomes Kidney allograft SLPI

    Time frame: peroperative blood samples before and after graft perfusion and urinary sample 6 hours after transplantion

    Measurement of reperfusion injury in blood and urine samples secretory leucocyte proteinase inhibitor SLPI

  7. Exploratory outcomes Liver allograft: Early allograft dysfunction

    Time frame: at 7 days

    Exploratory outcomes Liver allograft: Early allograft dysfunction according to Olthoff (Bil >100, INR 1.6 or more, ALT or AST > 2000 at 7th POD

  8. Exploratory outcomes Liver allograft: Highest ALT within 7th POD

    Time frame: within 7 days

    Exploratory outcomes Liver allograft: The highest ALT measurement within 7th POD

  9. Exploratory outcomes Liver allograft: Highest INR within 7th POD

    Time frame: within 7 days

    Exploratory outcomes Liver allograft: The highest INR measurement within 7th POD

  10. Exploratory outcomes Liver allograft: Highest Bil within 7th POD

    Time frame: within 7 days

    Exploratory outcomes Liver allograft: The highest Bil measurement within 7th POD

  11. Exploratory outcomes heart allografts: TnI

    Time frame: at 1 hour, 12 hours and 24 hours

    Exploratory outcomes heart allografts: TnI measurement

  12. Exploratory outcomes heart allografts: proBNP

    Time frame: at 1 day, 7 days, 14 days and 21 days

    Exploratory outcomes heart allografts: (12/09/2019 BNP changed to proBNP because of changes in Helsinki University Hospital HUSlab laboratory protocols)

  13. Exploratory outcomes heart allografts: crea

    Time frame: at 1 day, 7 days, 14 days and 21 days

    Exploratory outcomes heart allografts: crea

  14. Exploratory outcomes heart allografts: urea

    Time frame: at 1 day, 7 days, 14 days and 21 days

    Exploratory outcomes heart allografts: urea

  15. Exploratory outcomes heart allografts: eGFR

    Time frame: at 1 day, 7 days, 14 days and 21 days

    Exploratory outcomes heart allografts: eGFR

  16. Exploratory outcomes heart allografts: LVEF

    Time frame: at 1 day, 7 days, 14 days and 21 days

    Exploratory outcomes heart allografts: left ventricle ejection fraction

  17. Exploratory outcomes heart allografts: LV wall thickness

    Time frame: at 1 day, 7 days, 14 days and 21 days

    Exploratory outcomes heart allografts: left ventricle wall thickness measurements

  18. Exploratory outcomes heart allografts: tricuspidal leak

    Time frame: at 1 day, 7 days, 14 days and 21 days

    Exploratory outcomes heart allografts: grading of the tricuspidal valve leak

  19. Exploratory outcomes heart allografts: Ischaemia-reperfusion injury

    Time frame: at 7 days, 14 days and 21 days

    Exploratory outcomes heart allografts: The appearance of ischaemia-reperfusion injury in routine biopsies

  20. Exploratory outcomes heart allografts: fibrosis

    Time frame: at 7 days, 14 days and 21 days

    Exploratory outcomes heart allografts: The appearance of fibrosis associated factors in routine biopsies

  21. Exploratory outcomes heart allografts: long time follow-up of proBNP

    Time frame: at 1 month, 3 months, 6 months, 12 months

    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)

  22. Exploratory outcomes heart allografts: long time follow-up of LVEF

    Time frame: at 1 month, 3 months, 6 months, 12 months

    Exploratory outcomes heart allografts: long time follow-up of left ventricle ejection fraction in cardiac ECHO

  23. Exploratory outcomes heart allografts: CAD at 1 year

    Time frame: at 1 year

    Exploratory outcomes heart allografts: Coronary Artery Disease in coronary angiography at 1 year

  24. Exploratory outcomes heart allografts: MACE

    Time frame: at 1 month, 3 months, 6 months, 12 months

    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)

  25. Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury standardized P/F-ratio

    Time frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours

    Severity of ischemia/reperfusion injury after transplantation: standardized P/F-ratio during mechanical ventilation

  26. Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: non-standardized P/F-ratio

    Time frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours

    Severity of ischemia/reperfusion injury after transplantation: non-standardized P/F-ratio during mechanical ventilation

  27. Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: lactate

    Time frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours

    Severity of ischemia/reperfusion injury after transplantation , plasma lactate,

  28. Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: CRP

    Time frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours

    Severity of ischemia/reperfusion injury after transplantation: serum highly sensitive C-reactive protein

  29. Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: leuc

    Time frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours

    Severity of ischemia/reperfusion injury after transplantation blood leukocyte count

  30. Exploratory outcomes lung allografts: Severity of ischaemia/reperfusion injury: neut

    Time frame: at 0 hours, 1 hour, 6 hours, 12 hours and 24 hours

    Severity of ischemia/reperfusion injury after transplantation neutrophil count

  31. Exploratory outcomes lung allografts: FEV1

    Time frame: at 1 month, 3 months, 6 months, 12 months

    Exploratory outcomes lung allografts: FEV1

  32. Exploratory outcomes lung allografts: FVC

    Time frame: at 1 month, 3 months, 6 months, 12 months

    Exploratory outcomes lung allografts: FVC

  33. Exploratory outcomes lung allografts: chronic rejection

    Time frame: at 1 month, 3 months, 6 months, 12 months

    Exploratory outcomes lung allografts: chronic rejection

  34. Exploratory outcomes lung allografts: infections

    Time frame: at 1 month, 3 months, 6 months, 12 months

    Exploratory outcomes lung allografts: infections after transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Aki Uutela, MD

CONTACT

[email protected]

+358-9-4711

Ville Sallinen, MD, PhD

CONTACT

[email protected]

+358-9-4711

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Academy of Finland
  • Finska Läkaresällskapet (funding)
  • Helsinki University Hospital Research Funds (funding)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2042
First posted
Feb 27, 2019
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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