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.
NCT number | NCT03758352 |
Other study ID # | TRSPLNT001 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2020 |
Est. completion date | November 2022 |
Verified date | October 2020 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
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
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 |
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