Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation

NCT ID: NCT03012633

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-09

Study Completion Date

2017-07-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Lysis timer

Lysis Timer compared with standard laboratory test to diagnose hyperfibrinolysis during liver transplantation.

Intervention Type DEVICE

Other Intervention Names

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Global Fibrinolytic Capacity GFC test

Eligibility Criteria

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Inclusion Criteria

* adult patients benefiting from liver transplantation

Exclusion Criteria

* age under eighteen
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Alexandre OUATTARA

Head of department of Cardiovascular Anesthesia and Critical care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandre OUATTARA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

head of anesthesia department II

Locations

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BORDEAUX UNIVERSITY HOSPITAL Haut Lévêque

Pessac, , France

Site Status

Countries

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France

References

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Roullet S, Labrouche S, Mouton C, Quinart A, Nouette-Gaulain K, Laurent C, Freyburger G. Lysis Timer: a new sensitive tool to diagnose hyperfibrinolysis in liver transplantation. J Clin Pathol. 2019 Jan;72(1):58-65. doi: 10.1136/jclinpath-2018-205280. Epub 2018 Oct 3.

Reference Type DERIVED
PMID: 30282673 (View on PubMed)

Other Identifiers

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DC 2016/142

Identifier Type: -

Identifier Source: org_study_id

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