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QuantiXa: Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy

Sponsor
Direction Centrale du Service de Santé des Armées (Other)
Overall Status
Recruiting
CT.gov ID
NCT05993533
Collaborator
(none)
100
Enrollment
1
Location
6.3
Anticipated Duration (Months)
15.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Quantra(r) hemostasis analyzer (Stago) is a recent addition to the family of global hemostasis tests. It uses ultrasound-based technology to characterize the viscoelastic properties of a whole blood sample during coagulation. The Qplus(r) cartridge consists of independent channels, each containing different reagents that provide parallel measurements of 6 parameters.

This global test takes into account cellular elements such as platelets and red blood cells in clot formation, and also explores fibrinolysis. In addition, this test is of particular interest in delocalized biology, i.e. at the patient's bedside, and avoids the time-consuming laboratory centrifugation stage required for routine analyzers.

In practice, this test has been developed to monitor haemostasis in patients who may present with a range of coagulopathies of various etiologies, but also in the management of haemorrhagic patients, in order to adapt the administration of blood products in particular.

The Quantra (r) analyzer could therefore be of interest since it could be deployed in overseas operations to manage war casualties.

Recent studies (EACTAIC-ICCVA congress, October 2021) have shown that there is a good correlation between anti-Xa activity and the CTR (coagulation time ratio) parameter of the Quantra cartridge Qplus (TM), suggesting that this automated system could be used to manage anticoagulant therapy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy
    Actual Study Start Date :
    Jun 22, 2023
    Anticipated Primary Completion Date :
    Dec 22, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between anti-Xa activity and 'CTR' parameter [Through study completion (6 months)]

      The primary outcome is to compare anti-Xa activity results with the CTR (coagulation time ratio) parameter of the Qplus(r) cartridge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients over 18 and affiliated to the french social security system

    • Patients on curative heparin (low molecular weight heparin or non-fractionated heparin) for whom anti-Xa activity is prescribed or planned by the clinician

    • Samples taken between working hours

    • No opposition to study participation

    Exclusion Criteria:

    • Patients unable to consent

    • Anti-Xa activity not prescribed

    • Patients on another anticoagulant treatment or not anticoagulated about it

    • Samples taken during non-working hours

    • Pregnant or breast-feeding women

    • Insufficient language level for understanding the information note

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HIA Bégin Saint-Mandé France 94160

    Sponsors and Collaborators

    • Direction Centrale du Service de Santé des Armées

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Direction Centrale du Service de Santé des Armées
    ClinicalTrials.gov Identifier:
    NCT05993533
    Other Study ID Numbers:
    • 2022PPRC04
    • 2023-A00466-39
    First Posted:
    Aug 15, 2023
    Last Update Posted:
    Aug 15, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Direction Centrale du Service de Santé des Armées
    Anti Xa activity
    heparin treatment
    Additional relevant MeSH terms:
    Thromboembolism

    Study Results

    No Results Posted as of Aug 15, 2023