Venous Thromboembolic DiseaseQuantiXaNCT05993533
Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy
An observational study of Venous Thromboembolic Disease, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Venous Thromboembolic Disease
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is composed by hospitalized subjects under heparin therapy and who needs to undergo a blood control
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
HIA Bégin
Saint-Mandé, 94160
Aurore Bousquet, 1 43 98 52 18 ext. +33, aurore.bousquet@intradef.gouv.fr
About this study
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.
Read more
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start22 Jun 2023
- Primary completion22 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993533
- Sponsor's protocol ID
- 2022PPRC04
- Other IDs
- 2023-A00466-39
- Acronym
- QuantiXa
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy
- ClinicalTrials.gov ID
- NCT05993533
- Acronym / sponsor ID
- QuantiXa / 2022PPRC04
- Conditions
- Venous Thromboembolic Disease
- Keywords
- Anti Xa activity, heparin treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed by hospitalized subjects under heparin therapy and who needs to undergo a blood control
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolic Disease, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurore BOUSQUET (1 43 98 52 18 ext. +33, aurore.bousquet@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between anti-Xa activity and 'CTR' parameter (time frame: Through study completion (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.