Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation

NCT03012633 | Completed

• 1 other identifier: DC 2016/142
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Keywords

hyperfibrinolysis, Lysis Timer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Lysis timer DEVICE

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

Also known as: Global Fibrinolytic Capacity, GFC test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult patients benefiting from liver transplantation

You may qualify if:

• adult patients benefiting from liver transplantation

You may not qualify if:

• age under eighteen

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

BORDEAUX UNIVERSITY HOSPITAL Haut Lévêque

Pessac, 33604, France

Location

Related Publications (1)

• 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.

  PMID: 30282673 DERIVED

Study Officials

• Alexandre OUATTARA, MD, PhD

  head of anesthesia department II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of Cardiovascular Anesthesia and Critical care

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 6, 2017
• Study Start: January 9, 2017
• Primary Completion: June 14, 2017
• Study Completion: July 12, 2017
• Last Updated: May 17, 2024

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)