Liver Transplant; ComplicationsNCT03758352
The Effect of Remote Ischemic Preconditioning on Ischemia/Reperfusion Injury in a Liver Transplant Recipient
A study testing remote ischemic preconditioning (rIC) and non remote ischemic preconditioning (non-rIC) in people with Liver Transplant; Complications and Ischemia Reperfusion Injury, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Ischemia Reperfusion Injury
- What is being tested?
- remote ischemic preconditioning (rIC) and non remote ischemic preconditioning (non-rIC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients undergoing liver transplantation
- Patients aged 18 or above
- Patients who have given an informed consent
Who cannot join
- Patients undergoing re-transplantation.
- Patients who do not or cannot give an informed consent.
- Patients who have undergone surgery six weeks prior to liver transplantation.
- Patients with known peripheral vascular disease.
- Patients with an infection localized to the area of rIC-intervention
- Patients with at a high risk or with previous history of multiple thrombo-embolic diseases.
- Patients undergoing active immunosuppressive therapy
About this study
Official title: The Effect of Remote Ischemic Preconditioning on Ischemia/Reperfusion Injury in a Liver Transplant Recipient (TRSPLNT) - A Randomized, Controlled, Double-blinded Clinical Trial.
Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. However, preconditioning of the recipient may be a better approach due to the mechanisms by which ischemic preconditioning protects against ischemia and reperfusion injury.
The aim of this randomised, double-blinded clinical trial is to biochemically assess the liver function after application of remote ischemic preconditioning on the recipient.
Read the detailed description
Background The use of solid organ transplantation, including liver transplantation, is the golden standard for many end-stage solid organ diseases. Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. This may have a similar effect in a liver transplantation setting. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. However, preconditioning of the recipient may be a better approach due to the mechanisms by which ischemic preconditioning protects against ischemia and reperfusion injury.
The aim of this randomised, double-blinded clinical trial is to biochemically assess the liver function after application of remote ischemic preconditioning on the recipient.
Methods 52 patients undergoing a liver transplantation, included in accordance to the inclusion criteria, will be allocated to an intervention group (rIC-group) and compared to a retrospective non-intervention control group (non-rIC group) consisting of 52 patients. Patients in the non-intervention group will also be included in accordance to the inclusion criteria. Within two hours before surgery, patients in the intervention group will be subjected to four rounds of five-minute inflations and five-minute deflations of a pneumatic tourniquet applied on the right leg.
Follow-up time will be 30 days.
Measurements The aim of this trial is to assess the effect of remote ischemic preconditioning on the extent of liver injury and inflammation as a result of ischemia and reperfusion injury. Assessment will be done by measurement of biomarkers relevant to liver function and liver injury.
- Being tested
- remote ischemic preconditioning (rIC), non remote ischemic preconditioning (non-rIC)
- Keywords
- ischemia reperfusion injury, remote ischemic preconditioning, liver transplantation
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioning (rIC)Procedure or surgery
Short intermittent peripheral occlusions and reperfusions of the blood flow in the right lower extremity with the help of a tourniquet.
non remote ischemic preconditioning (non-rIC)Other
Retrospective group who have not undergone intervention.
| Study group | Role | What they receive |
|---|---|---|
| intervention group (rIC) | Experimental | The rIC procedure will be applied on seated patients, who have been resting for at least five minutes. The active rIC procedure consists of four five-minute inflations of a pneumatic tourniquet to 100 mmHg above the patient's systolic blood pressure separated by five-minute periods of complete deflation. Placement of the pneumatic tourniquet will be unilaterally on a lower limb (right thigh) Receives: Procedure: remote ischemic preconditioning (rIC) |
| control group (non-rIC) | Other | The control group will be a retrospective group, who have undergone a liver transplantation and meet the inclusion criteria. Receives: Other: non remote ischemic preconditioning (non-rIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative change in ALT
Extent of liver injury measured as change in ALT postoperative from day zero to day four .
Measured: Day 0-4
Secondary outcomes (4)
Post-operative change in Aspartate Amonitransferase
Serological markers of liver function
Measured: Day 0-4
Post-operative change in Bilirubin
Serological markers of liver function
Measured: Day 0-4
Post-operative change in Alkaline Phosphatase
Serological markers of liver function
Measured: Day 0-4
Post-operative change in International Normalised Ratio
Serological markers of liver function
Measured: Day 0-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study startApr 2020 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Large sample size
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 Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be allocated to an intervention group (rIC) and compared to a retrospective control group. Data assessment will be blinded to the assessor.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waqas Farooqui, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Waqas Farooqui, MD, Principal investigator, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758352
- Sponsor's protocol ID
- TRSPLNT001
- Status last verified
- Oct 2020
- First submitted
- 25 Nov 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Farooqui W, Pommergaard HC, Rasmussen A. Remote ischemic preconditioning of transplant recipients to reduce graft ischemia and reperfusion injuries: A systematic review. Transplant Rev (Orlando). 2018 Jan;32(1):10-15. doi: 10.1016/j.trre.2017.06.001. Epub 2017 Jun 15.
PubMed 28637593
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Preconditioning on Ischemia/Reperfusion Injury in a Liver Transplant Recipient (TRSPLNT) - A Randomized, Controlled, Double-blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT03758352
- Acronym / sponsor ID
- TRSPLNT001
- Keywords
- ischemia reperfusion injury, remote ischemic preconditioning, liver transplantation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Large sample size
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 29 Nov 2018 (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.
Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. However, preconditioning of the recipient may be a better approach due to the mechanisms by which ischemic preconditioning protects against ischemia and reperfusion injury.
The aim of this randomised, double-blinded clinical trial is to biochemically assess the liver function after application of remote ischemic preconditioning on the recipient.
Detailed description
Background The use of solid organ transplantation, including liver transplantation, is the golden standard for many end-stage solid organ diseases. Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. This may have a similar effect in a liver transplantation setting. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. However, preconditioning of the recipient may be a better approach due to the mechanisms by which ischemic preconditioning protects against ischemia and reperfusion injury.
The aim of this randomised, double-blinded clinical trial is to biochemically assess the liver function after application of remote ischemic preconditioning on the recipient.
Methods 52 patients undergoing a liver transplantation, included in accordance to the inclusion criteria, will be allocated to an intervention group (rIC-group) and compared to a retrospective non-intervention control group (non-rIC group) consisting of 52 patients. Patients in the non-intervention group will also be included in accordance to the inclusion criteria. Within two hours before surgery, patients in the intervention group will be subjected to four rounds of five-minute inflations and five-minute deflations of a pneumatic tourniquet applied on the right leg.
Follow-up time will be 30 days.
Measurements The aim of this trial is to assess the effect of remote ischemic preconditioning on the extent of liver injury and inflammation as a result of ischemia and reperfusion injury. Assessment will be done by measurement of biomarkers relevant to liver function and liver injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be allocated to an intervention group (rIC) and compared to a retrospective control group. Data assessment will be blinded to the assessor.
| Arm | Type | Receives |
|---|---|---|
| intervention group (rIC) | Experimental | Procedure: remote ischemic preconditioning (rIC)The rIC procedure will be applied on seated patients, who have been resting for at least five minutes. The active rIC procedure consists of four five-minute inflations of a pneumatic tourniquet to 100 mmHg above the patient's systolic blood pressure separated by five-minute periods of complete deflation. Placement of the pneumatic tourniquet will be unilaterally on a lower limb (right thigh) |
| control group (non-rIC) | Other | Other: non remote ischemic preconditioning (non-rIC)The control group will be a retrospective group, who have undergone a liver transplantation and meet the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing liver transplantation
- Patients aged 18 or above
- Patients who have given an informed consent
Key exclusion criteria (7 listed)
- Patients undergoing re-transplantation.
- Patients who do not or cannot give an informed consent.
- Patients who have undergone surgery six weeks prior to liver transplantation.
- Patients with known peripheral vascular disease.
- Patients with an infection localized to the area of rIC-intervention
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 |
|---|---|---|
| remote ischemic preconditioning (rIC)Short intermittent peripheral occlusions and reperfusions of the blood flow in the right lower extremity with the help of a tourniquet. | Procedure or surgery | intervention group (rIC) |
| non remote ischemic preconditioning (non-rIC)Retrospective group who have not undergone intervention. | Other | control group (non-rIC) |
Primary outcome
Post-operative change in ALT
Time frame: Day 0-4
Extent of liver injury measured as change in ALT postoperative from day zero to day four .
4 secondary outcomes
Post-operative change in Aspartate Amonitransferase
Time frame: Day 0-4
Post-operative change in Bilirubin
Time frame: Day 0-4
Post-operative change in Alkaline Phosphatase
Time frame: Day 0-4
Post-operative change in International Normalised Ratio
Time frame: Day 0-4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 28637593Farooqui W, Pommergaard HC, Rasmussen A. Remote ischemic preconditioning of transplant recipients to reduce graft ischemia and reperfusion injuries: A systematic review. Transplant Rev (Orlando). 2018 Jan;32(1):10-15. doi: 10.1016/j.trre.2017.06.001. Epub 2017 Jun 15.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Waqas Farooqui, MD principal investigator
Doctor
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic preconditioning (rIC) and non remote ischemic preconditioning (non-rIC) in people with Liver Transplant; Complications and Ischemia Reperfusion Injury, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative change in ALT (time frame: Day 0-4). 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 NCT03758352, 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 8 Oct 2020.