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

NCT05993533 | Unknown

• 2 other identifiers: 2022PPRC042023-A00466-39
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolic Disease

Keywords

Anti Xa activity; heparin treatment

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

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

Study Population

The study population is composed by hospitalized subjects under heparin therapy and who needs to undergo a blood control

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

HIA Bégin

Saint-Mandé, 94160, France

RECRUITING

Central Study Contacts

Aurore BOUSQUET

CONTACT

1 43 98 52 18; aurore.bousquet@intradef.gouv.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: June 22, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 31, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

FR (1)