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Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation

NCT03012633 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-05-17

No results posted yet for this study

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.

Conditions

  • Liver Transplantation

Interventions

DEVICE

Lysis timer

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

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Alexandre OUATTARA, MD, PhD · head of anesthesia department II

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-09
Primary Completion
2017-06-14
Completion
2017-07-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03012633 on ClinicalTrials.gov