Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 5:26 PM
Study NCT ID:
NCT05993533
Status:
UNKNOWN
Last Update Posted:
2023-08-15
First Post:
2023-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2023-08-07', 'studyFirstSubmitQcDate': '2023-08-07', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Correlation between anti-Xa activity and 'CTR' parameter", 'timeFrame': 'Through study completion (6 months)', 'description': 'The primary outcome is to compare anti-Xa activity results with the CTR (coagulation time ratio) parameter of the Qplus(r) cartridge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti Xa activity', 'heparin treatment'], 'conditions': ['Venous Thromboembolic Disease']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nIn 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.\n\nThe Quantra (r) analyzer could therefore be of interest since it could be deployed in overseas operations to manage war casualties.\n\nRecent 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed by hospitalized subjects under heparin therapy and who needs to undergo a blood control', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 and affiliated to the french social security system\n* Patients on curative heparin (low molecular weight heparin or non-fractionated heparin) for whom anti-Xa activity is prescribed or planned by the clinician\n* Samples taken between working hours\n* No opposition to study participation\n\nExclusion Criteria:\n\n* Patients unable to consent\n* Anti-Xa activity not prescribed\n* Patients on another anticoagulant treatment or not anticoagulated about it\n* Samples taken during non-working hours\n* Pregnant or breast-feeding women\n* Insufficient language level for understanding the information note'}, 'identificationModule': {'nctId': 'NCT05993533', 'acronym': 'QuantiXa', 'briefTitle': "Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy", 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': "Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy", 'orgStudyIdInfo': {'id': '2022PPRC04'}, 'secondaryIdInfos': [{'id': '2023-A00466-39', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94160', 'city': 'Saint-Mandé', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurore Bousquet', 'role': 'CONTACT', 'email': 'aurore.bousquet@intradef.gouv.fr', 'phone': '1 43 98 52 18', 'phoneExt': '+33'}], 'facility': 'HIA Bégin', 'geoPoint': {'lat': 48.83864, 'lon': 2.41579}}], 'centralContacts': [{'name': 'Aurore BOUSQUET', 'role': 'CONTACT', 'email': 'aurore.bousquet@intradef.gouv.fr', 'phone': '1 43 98 52 18', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}