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

Liver Transplant; Complications Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03758352
• Other study ID #: TRSPLNT001
• Status: Withdrawn
• Phase: N/A
• Start date: April 2020
• Est. completion date: November 2022

Study information

• Verified date: October 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemia Reperfusion Injury
• Liver Transplant; Complications
• Reperfusion Injury
• Wounds and Injuries

Intervention

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.

Other:
• non remote ischemic preconditioning (non-rIC)
Retrospective group who have not undergone intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication rate	Rate of post-operative complications	Follow-up on day 30
Other	Days in ICU (Intensive Care Unit)	Length of post-operative stay in ICU	Follow-up on day 30
Other	Total length of hospital-stay		Follow-up on day 30
Primary	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	Post-operative change in Aspartate Amonitransferase	Serological markers of liver function	Day 0-4
Secondary	Post-operative change in Bilirubin	Serological markers of liver function	Day 0-4
Secondary	Post-operative change in Alkaline Phosphatase	Serological markers of liver function	Day 0-4
Secondary	Post-operative change in International Normalised Ratio	Serological markers of liver function	Day 0-4