NCT03758352

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

November 25, 2018

Last Update Submit

October 5, 2020

Conditions

Liver Transplant; ComplicationsIschemia Reperfusion Injury

Keywords

ischemia reperfusion injuryremote ischemic preconditioningliver transplantation

Outcome Measures

Primary Outcomes (1)

  • Post-operative change in ALT

    Extent of liver injury measured as change in ALT postoperative from day zero to day four .

    Day 0-4

Secondary Outcomes (4)

  • Post-operative change in Aspartate Amonitransferase

    Day 0-4

  • Post-operative change in Bilirubin

    Day 0-4

  • Post-operative change in Alkaline Phosphatase

    Day 0-4

  • Post-operative change in International Normalised Ratio

    Day 0-4

Other Outcomes (3)

  • Complication rate

    Follow-up on day 30

  • Days in ICU (Intensive Care Unit)

    Follow-up on day 30

  • Total length of hospital-stay

    Follow-up on day 30

Study Arms (2)

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)

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.

Other: non remote ischemic preconditioning (non-rIC)

Interventions

remote ischemic preconditioning (rIC)PROCEDURE

Short intermittent peripheral occlusions and reperfusions of the blood flow in the right lower extremity with the help of a tourniquet.

intervention group (rIC)
non remote ischemic preconditioning (non-rIC)OTHER

Retrospective group who have not undergone intervention.

control group (non-rIC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28637593BACKGROUND

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Waqas Farooqui, MD

    Doctor

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients will be allocated to an intervention group (rIC) and compared to a retrospective control group. Data assessment will be blinded to the assessor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 29, 2018

Study Start

April 1, 2020

Primary Completion

June 1, 2022

Study Completion

November 1, 2022

Last Updated

October 8, 2020

Record last verified: 2020-10