Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation

Liver Transplantation Clinical Trial

— FILYTHO  

Official title:

Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012633
• Other study ID #: DC 2016/142
• Status: Completed
• Start date: January 9, 2017
• Est. completion date: July 12, 2017

Study information

• Verified date: November 2016
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The primary aim of this prospective, monocentric, observational study is to evaluate the Lysis Timer as a rapid diagnostic device for hyperfibrinolysis during liver transplantation. Lysis times provided by this device will be compared to the euglobulin lysis times and to the others parameters of fibrinolysis at the different stages of liver transplantation and more specifically at the anhepatic stage and after graft revascularization.

The secondary aims are to compare the results of the Lysis Timer, the thromboelastogram, the thrombin generation test and the standard laboratory tests in the context of hyperfibrinolysis during liver transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 12, 2017
• Est. primary completion date: June 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients benefiting from liver transplantation

Exclusion Criteria:

• age under eighteen

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Device:
• Lysis timer
Lysis Timer compared with standard laboratory test to diagnose hyperfibrinolysis during liver transplantation.

Locations

Country	Name	City	State
France	BORDEAUX UNIVERSITY HOSPITAL Haut Lévêque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clot lysis time	clot lysis time obtained quickly with "Lysis Timer "is compared with standard laboratory tests to diagnose hyperfibrinolysis during liver transplantation surgery.	during the liver transplantation surgery