Comparing a new hemostasis test with standard methods for patients on heparin therapy
Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy
Direction Centrale du Service de Santé des Armées · NCT05993533
This study is testing a new blood test to see if it can better help doctors monitor patients on heparin therapy for blood clots compared to standard methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Direction Centrale du Service de Santé des Armées (other) |
| Locations | 1 site (Saint-Mandé) |
| Trial ID | NCT05993533 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of the Quantra hemostasis analyzer in monitoring patients undergoing heparin therapy for venous thromboembolic disease. The analyzer uses ultrasound technology to assess the viscoelastic properties of blood during coagulation, providing real-time insights at the patient's bedside. By measuring multiple hemostatic parameters simultaneously, the study aims to improve the management of coagulation disorders and optimize treatment strategies for patients receiving heparin. The study focuses on patients who are prescribed anti-Xa activity monitoring as part of their treatment plan.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are on curative heparin therapy and have anti-Xa activity monitoring prescribed.
Not a fit: Patients who are unable to consent, not on anticoagulant treatment, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring of coagulation in patients on heparin, leading to better management of their treatment and potentially improved outcomes.
How similar studies have performed: While this approach is relatively novel, similar studies using advanced hemostasis testing have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint-Mandé
- HIA Bégin — Saint-Mandé, France (RECRUITING)
Study contacts
- Study coordinator: Aurore BOUSQUET
- Email: aurore.bousquet@intradef.gouv.fr
- Phone: 1 43 98 52 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Venous Thromboembolic Disease, Anti Xa activity, heparin treatment