Clinical trial NCT03758352: The Effect of Remote Ischemic Preconditioning on Ischemia/Reperfusion Injury in a Liver Transplant Recipient
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Liver Transplant; Complications
Ischemia Reperfusion Injury
Keywords: ischemia reperfusion injury
remote ischemic preconditioning
liver transplantation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Post-operative change in ALT
timeFrame: Day 0-4
Secondary outcomes:
measure: Post-operative change in Aspartate Amonitransferase
timeFrame: Day 0-4
measure: Post-operative change in Bilirubin
timeFrame: Day 0-4
measure: Post-operative change in Alkaline Phosphatase
timeFrame: Day 0-4
measure: Post-operative change in International Normalised Ratio
timeFrame: Day 0-4
Other outcomes:
measure: Complication rate
timeFrame: Follow-up on day 30
measure: Days in ICU (Intensive Care Unit)
timeFrame: Follow-up on day 30
measure: Total length of hospital-stay
timeFrame: Follow-up on day 30
Locations:
Study officials:
affiliation: Doctor
name: Waqas Farooqui, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.