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Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation (FILYTHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03012633
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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.


Condition or disease Intervention/treatment
Liver Transplantation Device: Lysis timer

Detailed 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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Lysis timer
    Lysis Timer compared with standard laboratory test to diagnose hyperfibrinolysis during liver transplantation.
    Other Names:
    • Global Fibrinolytic Capacity
    • GFC test


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients benefiting from liver transplantation
Criteria

Inclusion Criteria:

  • adult patients benefiting from liver transplantation

Exclusion Criteria:

  • age under eighteen

Information from the National Library of Medicine

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


Locations
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France
BORDEAUX UNIVERSITY HOSPITAL Haut Lévêque
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Alexandre OUATTARA, MD, PhD head of anesthesia department II
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03012633    
Other Study ID Numbers: DC 2016/142
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Bordeaux:
hyperfibrinolysis, Lysis Timer