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

Venous Thromboembolic Disease Clinical Trial

— QuantiXa  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05993533
• Other study ID #: 2022PPRC04
• Secondary ID: 2023-A00466-39
• Status: Recruiting
• Start date: June 22, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Aurore BOUSQUET
• Phone: 1 43 98 52 18
• Email: aurore.bousquet[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolic Disease

Locations

Country	Name	City	State
France	HIA Bégin	Saint-Mandé

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between anti-Xa activity and 'CTR' parameter	The primary outcome is to compare anti-Xa activity results with the CTR (coagulation time ratio) parameter of the Qplus(r) cartridge	Through study completion (6 months)