Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation (FILYTHO)
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|ClinicalTrials.gov Identifier: NCT03012633|
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : December 14, 2017
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.
|Condition or disease||Intervention/treatment|
|Liver Transplantation||Device: Lysis timer|
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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation|
|Actual Study Start Date :||January 9, 2017|
|Actual Primary Completion Date :||June 14, 2017|
|Actual Study Completion Date :||July 12, 2017|
- Device: Lysis timer
Lysis Timer compared with standard laboratory test to diagnose hyperfibrinolysis during liver transplantation.Other Names:
- Global Fibrinolytic Capacity
- GFC test
- clot lysis time [ Time Frame: during the liver transplantation surgery ]clot lysis time obtained quickly with "Lysis Timer "is compared with standard laboratory tests to diagnose hyperfibrinolysis during liver transplantation surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012633
|BORDEAUX UNIVERSITY HOSPITAL Haut Lévêque|
|Pessac, France, 33604|
|Principal Investigator:||Alexandre OUATTARA, MD, PhD||head of anesthesia department II|