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

August 7, 2023 updated by: Direction Centrale du Service de Santé des Armées

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between anti-Xa activity and 'CTR' parameter
Time Frame: 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
Through study completion (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Estimated)

December 22, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PPRC04
  • 2023-A00466-39 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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