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NCT03012633: FILYTHO

Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation

Completed Last updated 17 May 2024
What this trial tests

trial testing Lysis timer in Liver Transplantation in 30 participants. Completed in 12 July 2017.

Timeline
9 January 2017
Primary endpoint
14 June 2017
12 July 2017

Quick facts

Lead sponsorUniversity Hospital, Bordeaux
StatusCompleted
Study typeOBSERVATIONAL
Enrollment30
Start date9 January 2017
Primary completion14 June 2017
Estimated completion12 July 2017
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

During liver transplantation (LT), hyperfibrinolysis is one of the most important modification of haemostasis. It is associated with t-PA and protein C increased activity. Hyperfibrinolysis is frequent, hardly predictable and associated with major bleeding. The diagnostic of hyperfibrinolysis with standard laboratory tests (euglobulin lysis test, t-PA, PAI-1 and D-dimers dosages) does not provide an answer in a delay compatible with the clinical practice in the operating room. The "Lysis Timer" is a device developed by Hyphen-Sysmex in collaboration with SD Innovation and Charleroi University Hospital (Belgium). It allows the implementation of the "Global Fibrinolytic Capacity", or GFC test, in a complete system associating i) the reagents for in vitro triggering of the clot and its lysis (contact system activators, t-PA, thrombin and calcium), ii) the signal acquisition by the Lysis Timer (able to convert the analogic signal of the absorbance modifications related to clot formation into a numeric signal) and iii) a dedicated software treating the numeric signal to define clot lysis time. The GFC test, using t-PA to shorten signal acquisition times, is particularly adapted to the diagnosis of hyperfibrinolysis with PAI-1 collapse, of which LT is an example.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Lysis Timer: a new sensitive tool to diagnose hyperfibrinolysis in liver transplantation.
    Roullet S, Labrouche S, Mouton C, Quinart A, et al · · 2019 · cited 13× · PMID 30282673 · DOI 10.1136/jclinpath-2018-205280

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Other recruiting trials for Liver Transplantation

Currently open trials in the same condition.

Other University Hospital, Bordeaux trials

Trials by the same sponsor.

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