CLOTBUST-L: Fibrinolysis during normothermic perfusion of DCD livers
Research type
Research Study
Full title
CLOTBUST-L: An open-label, multicentre, randomised controlled trial to evaluate the efficacy of ex situ fibrinolysis during normothermic perfusion in liver transplantation from donation after circulatory death donors
IRAS ID
332692
Contact name
Vasilis Kosmoliaptsis
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
3 years, 7 months, 11 days
Research summary
Transplanted livers are susceptible to develop scarring in the bile ducts due to blockage of the blood supply to the wall of the bile duct around the time of transplant. These blocks are thought to be caused by blood clots developing as the
liver recovers from a period of storage outside the body. The walls of bile ducts that have had their blood supply blocked then heal by scarring, causing narrowed areas in the duct (strictures). Livers from donors donated after circulatory death (DCD), as opposed to those who donate after brain death (DBD), are particularly prone to develop this problem.
This study will randomly assign a donated DCD liver to either of two arms. The standard of care will require sites to place the liver on ice (static cold storage) or place a liver on a normothermic perfusion machine outside the body – depending on their normal, local procedure. Livers assigned to the intervention arm will use the same perfusion machine but with the addition of a clot busting treatment (alteplase and fresh frozen plasma) that has been shown to break down clots that form before the liver is transplanted. This clot busting treatment cannot be given after a transplant because of the risk of bleeding in the recipient, something that does not appear to be a problem when it is given on a perfusion machine in our previous work.This is a multicentre study to test the efficiency of the clot busting treatment in preventing bile duct strictures.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0229
Date of REC Opinion
23 Aug 2025
REC opinion
Favourable Opinion