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| Name | Class |
|---|---|
| Finska Läkaresällskapet (funding) | UNKNOWN |
| Academy of Finland | OTHER |
| Helsinki University Hospital Research Funds (funding) | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPC | Experimental | 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. |
|
| Sham-RIPC | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIPC | Procedure | Remote Ischaemic Preconditioning |
| |
| Sham-RIPC |
| Measure | Description | Time Frame |
|---|---|---|
| DGF | Delayed graft function of kidney allografts defined as postoperative dialysis within 1 week from transplantation | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney allografts: eGFR | Kidney allografts: estimated glomerular filtration rate | at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year |
| Combined Pancreas-Kidney allografts: eGFR | Combined Pancreas-Kidney allografts: estimated glomerular filtration rate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Exploratory outcomes Kidney allograft miR-24 |
Donor Inclusion Criteria:
Donor Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ville Sallinen, MD, PhD | Contact | +358-9-4711 | ville.sallinen@helsinki.fi | |
| Aki Uutela, MD | Contact | +358-9-4711 | aki.uutela@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Aki Uutela, MD | Helsinki University Central Hospital | Principal Investigator |
| Ville Sallinen, MD, PhD | Helsinki University Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Recruiting | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33199419 | Derived | 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. |
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After the completion of the study the depersonalized data can be requested from the authors.
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| Procedure |
Sham procedure |
|
| at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year |
| Kidney allografts: BPAR | Kidney allografts: Biopsy proven acute rejection | within 1 year |
| Combined Pancreas-Kidney allografts: Kidney BPAR | Combined Pancreas-Kidney allografts: Biopsy proven acute rejection in Kidney allograft | within 1 year |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Liver allografts: BPAR | Liver allografts: Biopsy proven acute rejection | within 1 year |
| 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 |
| Pancreas allografts: HbA1c | Pancreas allografts: blood HbA1c measurement | at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year |
| 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 |
| 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 |
| 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 |
| Heart allograft: TnI at 6 hours | Heart allograft: blood TnI measurement at 6 hours after transplantation | at 6 hours |
| 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 |
| Heart allograft: Primary graft dysfunction | Heart allograft: Primary graft dysfunction according to ISHLT (2014) | within 24 hours after transplantation |
| Heart allograft: acute rejection | Heart allograft: Biopsy proven or clinically treated acute rejection | within 1 year |
| 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 |
| 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 |
| Lung allograft: Primary graft dysfunction | Lung allograft: Primary graft dysfunction according to ISHLT | within 72 hours |
| Lung allograft: Acute rejection | Lung allograft: Biopsy proven or clinically treated acute rejection | within 1 year |
| 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 |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Exploratory outcomes Liver allograft: Highest ALT within 7th POD | Exploratory outcomes Liver allograft: The highest ALT measurement within 7th POD | within 7 days |
| Exploratory outcomes Liver allograft: Highest INR within 7th POD | Exploratory outcomes Liver allograft: The highest INR measurement within 7th POD | within 7 days |
| Exploratory outcomes Liver allograft: Highest Bil within 7th POD | Exploratory outcomes Liver allograft: The highest Bil measurement within 7th POD | within 7 days |
| Exploratory outcomes heart allografts: TnI | Exploratory outcomes heart allografts: TnI measurement | at 1 hour, 12 hours and 24 hours |
| 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 |
| Exploratory outcomes heart allografts: crea | Exploratory outcomes heart allografts: crea | at 1 day, 7 days, 14 days and 21 days |
| Exploratory outcomes heart allografts: urea | Exploratory outcomes heart allografts: urea | at 1 day, 7 days, 14 days and 21 days |
| Exploratory outcomes heart allografts: eGFR | Exploratory outcomes heart allografts: eGFR | at 1 day, 7 days, 14 days and 21 days |
| Exploratory outcomes heart allografts: LVEF | Exploratory outcomes heart allografts: left ventricle ejection fraction | at 1 day, 7 days, 14 days and 21 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Exploratory outcomes heart allografts: CAD at 1 year | Exploratory outcomes heart allografts: Coronary Artery Disease in coronary angiography at 1 year | at 1 year |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Exploratory outcomes lung allografts: FEV1 | Exploratory outcomes lung allografts: FEV1 | at 1 month, 3 months, 6 months, 12 months |
| Exploratory outcomes lung allografts: FVC | Exploratory outcomes lung allografts: FVC | at 1 month, 3 months, 6 months, 12 months |
| Exploratory outcomes lung allografts: chronic rejection | Exploratory outcomes lung allografts: chronic rejection | at 1 month, 3 months, 6 months, 12 months |
| Exploratory outcomes lung allografts: infections | Exploratory outcomes lung allografts: infections after transplantation | at 1 month, 3 months, 6 months, 12 months |
| Marko Lempinen, MD, PhD |
| Helsinki University Central Hospital |
| Study Chair |