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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05993533
Acronym
QuantiXa
Enrollment
100
Registered
2023-08-15
Start date
2023-06-22
Completion date
2023-12-31
Last updated
2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolic Disease

Keywords

Anti Xa activity, heparin treatment

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.

Interventions

None listed

Sponsors

Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between anti-Xa activity and 'CTR' parameterThrough 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

Countries

France

Contacts

Primary ContactAurore BOUSQUET
aurore.bousquet@intradef.gouv.fr1 43 98 52 18

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026