Transplant DysfunctionNCT03855722
Remote Ischaemic Preconditioning in Transplantation (RIPTRANS)
A study testing RIPC in people with Transplant Dysfunction, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Dysfunction
- What is being tested?
- RIPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 496 participants
- Where
- 1 siteFinland
- Study dates
- 12 Mar 2019to Feb 2042
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, 00029
Ville Sallinen, MD, PhD, +358-9-4711, ville.sallinen@helsinki.fi
Aki Uutela, MD, +358-9-4711, aki.uutela@hus.fi
About this study
Official title: Remote Ischaemic Preconditioning in Transplantation (RIPTRANS) - A Prospective Randomized Controlled Trial
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.
- Conditions
- Transplant Dysfunction
- Being tested
- RIPC, Sham-RIPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPCProcedure or surgery
Remote Ischaemic Preconditioning
Sham-RIPCProcedure or surgery
Sham procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: RIPC |
| 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. Receives: Procedure: Sham-RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
DGF
Delayed graft function of kidney allografts defined as postoperative dialysis within 1 week from transplantation
Measured: 7 days
Secondary outcomes (27)
Kidney allografts: eGFR
Kidney allografts: estimated glomerular filtration rate
Measured: 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
Measured: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Kidney allografts: BPAR
Kidney allografts: Biopsy proven acute rejection
Measured: within 1 year
Combined Pancreas-Kidney allografts: Kidney BPAR
Combined Pancreas-Kidney allografts: Biopsy proven acute rejection in Kidney allograft
Measured: within 1 year
Kidney allografts: graft survival
Kidney allografts: time from transplantation to death, retransplantation or permanent dialysis
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: within 1 year
Liver allografts: Posttransplantation kidney injury
Liver allografts: Posttransplantation kidney injury (acute kidney injury) according to ADQI (2010) criteria
Measured: within 1 week, at 3 months, 1 year
Liver allografts: BPAR
Liver allografts: Biopsy proven acute rejection
Measured: within 1 year
Liver allografts: graft survival
Liver allografts: graft survival: time from transplantation to death, retransplantation or explantation
Measured: at 1 year, 2 year, 5 year, 10 year, and 20 year
Pancreas allografts: HbA1c
Pancreas allografts: blood HbA1c measurement
Measured: 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
Measured: within 1 year
Pancreas allografts: Pancreatic allograft survival
Pancreas allografts: Time from transplantation to death, retransplantation, explantation or daily insulin dependance
Measured: 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
Measured: 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
Measured: 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)
Measured: at 1 week
Heart allograft: Primary graft dysfunction
Heart allograft: Primary graft dysfunction according to ISHLT (2014)
Measured: within 24 hours after transplantation
Heart allograft: acute rejection
Heart allograft: Biopsy proven or clinically treated acute rejection
Measured: within 1 year
Heart allograft: Vasculopathy-free survival
Heart allograft: Vasculopathy-free survival according to Mehra (2010)
Measured: 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
Measured: 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
Measured: within 72 hours
Lung allograft: Acute rejection
Lung allograft: Biopsy proven or clinically treated acute rejection
Measured: within 1 year
Lung allograft: CLAD-free survival
Lung allograft: Chronic Lung Allograft Dysfunction (CLAD) free survival according to Verleden (2014)
Measured: 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.)
Measured: at 1, 2, 5, 10 and 20 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start12 Mar 2019
- Primary completionMar 2022 (estimated)
- Study completionFeb 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transplant DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Finska Läkaresällskapet (funding), Academy of Finland, Helsinki University Hospital Research Funds (funding)
- Responsible party
- Principal investigator, Ville Sallinen, Helsinki University Central Hospital
- Investigators
- Aki Uutela, MD, Principal investigator, Helsinki University Central HospitalVille Sallinen, MD, PhD, Study director, Helsinki University Central HospitalMarko Lempinen, MD, PhD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855722
- Sponsor's protocol ID
- RIPTRANS
- Status last verified
- Mar 2020
- First submitted
- 11 Feb 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the completion of the study the depersonalized data can be requested from the authors.
Publications
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.
PubMed 33199419
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischaemic Preconditioning in Transplantation (RIPTRANS) - A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03855722
- Acronym / sponsor ID
- RIPTRANS
- Conditions
- Transplant Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Finska Läkaresällskapet (funding), Academy of Finland, Helsinki University Hospital Research Funds (funding)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Feb 2042 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC | Experimental | Procedure: RIPCRIPC 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 | Procedure: Sham-RIPCSham-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIPCRemote Ischaemic Preconditioning | Procedure or surgery | RIPC |
| Sham-RIPCSham procedure | Procedure or surgery | Sham-RIPC |
Primary outcome
DGF
Time frame: 7 days
Delayed graft function of kidney allografts defined as postoperative dialysis within 1 week from transplantation
27 secondary outcomes
Kidney allografts: eGFR
Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Combined Pancreas-Kidney allografts: eGFR
Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Kidney allografts: BPAR
Time frame: within 1 year
Combined Pancreas-Kidney allografts: Kidney BPAR
Time frame: within 1 year
Kidney allografts: graft survival
Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Combined Pancreas-Kidney allografts: kidney graft survival
Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Kidney allografts: death-censored graft survival
Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
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
Liver allografts: MEAF-score at 3rd POD
Time frame: 3rd post-operative day
Liver allografts: Postoperative biliary complications
Time frame: within 1 year
Liver allografts: Posttransplantation kidney injury
Time frame: within 1 week, at 3 months, 1 year
Liver allografts: BPAR
Time frame: within 1 year
Liver allografts: graft survival
Time frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Pancreas allografts: HbA1c
Time frame: at 3 months, 1 year, 2 year, 5 year, 10 year, and 20 year
Pancreas allografts: Acute rejection
Time frame: within 1 year
Pancreas allografts: Pancreatic allograft survival
Time frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Pancreas allografts: Death-censored Pancreatic allograft survival
Time frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Heart allograft: TnI at 6 hours
Time frame: at 6 hours
Heart allograft: proBNP at 1 week
Time frame: at 1 week
Heart allograft: Primary graft dysfunction
Time frame: within 24 hours after transplantation
Heart allograft: acute rejection
Time frame: within 1 year
Heart allograft: Vasculopathy-free survival
Time frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Heart allograft: graft survival
Time frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Lung allograft: Primary graft dysfunction
Time frame: within 72 hours
Lung allograft: Acute rejection
Time frame: within 1 year
Lung allograft: CLAD-free survival
Time frame: at 1 year, 2 year, 5 year, 10 year, and 20 year
Lung allograft: graft survival
Time frame: at 1, 2, 5, 10 and 20 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 33199419Uutela 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.
- Individual participant dataSharing planned: No. After the completion of the study the depersonalized data can be requested from the authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aki Uutela, MD principal investigator
Helsinki University Central Hospital
Ville Sallinen, MD, PhD study director
Helsinki University Central Hospital
Marko Lempinen, MD, PhD study chair
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPC in people with Transplant Dysfunction, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ville Sallinen, MD, PhD (+358-9-4711, ville.sallinen@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DGF (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03855722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.