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The Effect of Remote Ischemic Preconditioning on Ischemia/Reperfusion Injury in a Liver Transplant Recipient

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ClinicalTrials.gov Identifier: NCT03758352
Recruitment Status : Withdrawn (Large sample size)
First Posted : November 29, 2018
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Waqas Farooqui, Rigshospitalet, Denmark

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Liver Transplant; Complications Ischemia Reperfusion Injury Procedure: remote ischemic preconditioning (rIC) Other: non remote ischemic preconditioning (non-rIC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: The patient enrolment will be done by the on-call doctor and intervention will be performed by unblinded research personnel who won't be involved in sample collection or data analysis.
Primary Purpose: Prevention
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.
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention group (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)
Procedure: 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.

control group (non-rIC)
The control group will be a retrospective group, who have undergone a liver transplantation and meet the inclusion criteria.
Other: non remote ischemic preconditioning (non-rIC)
Retrospective group who have not undergone intervention.




Primary Outcome Measures :
  1. 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 .


Secondary Outcome Measures :
  1. Post-operative change in Aspartate Amonitransferase [ Time Frame: Day 0-4 ]
    Serological markers of liver function

  2. Post-operative change in Bilirubin [ Time Frame: Day 0-4 ]
    Serological markers of liver function

  3. Post-operative change in Alkaline Phosphatase [ Time Frame: Day 0-4 ]
    Serological markers of liver function

  4. Post-operative change in International Normalised Ratio [ Time Frame: Day 0-4 ]
    Serological markers of liver function


Other Outcome Measures:
  1. Complication rate [ Time Frame: Follow-up on day 30 ]
    Rate of post-operative complications

  2. Days in ICU (Intensive Care Unit) [ Time Frame: Follow-up on day 30 ]
    Length of post-operative stay in ICU

  3. Total length of hospital-stay [ Time Frame: Follow-up on day 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing liver transplantation
  • Patients aged 18 or above
  • Patients who have given an informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758352


Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Waqas Farooqui, MD Doctor
Publications:
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Responsible Party: Waqas Farooqui, MD, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03758352    
Other Study ID Numbers: TRSPLNT001
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Waqas Farooqui, Rigshospitalet, Denmark:
ischemia reperfusion injury
remote ischemic preconditioning
liver transplantation
Additional relevant MeSH terms:
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Reperfusion Injury
Ischemia
Wounds and Injuries
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications