Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-03 @ 6:40 AM
Study NCT ID:
NCT03773159
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2018-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014842', 'term': 'von Willebrand Diseases'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repeatability and reproducibility of the result in controls', 'timeFrame': 'Baseline'}, {'measure': 'Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Von Willebrand Diseases', 'Major Constitutional Thrombopathy', 'Patient on Antiplatelet Drugs']}, 'descriptionModule': {'briefSummary': 'Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions.\n\nAn exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).\n\nThe objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions.\n\nParticipation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with von Willebrand disease or major constitutional thrombopathy or patient on antiplatelet drugs', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* person who has given oral consent\n* adult\n* blood donor at EFS Bourgogne Franche-Comté\n* or patient with von Willebrand disease or major constitutional thrombopathy followed by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of Dijon or Besançon\n* or patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or Besançon Hospital\n\nExclusion Criteria:\n\n* a person who is not affiliated to or not a beneficiary of national health insurance\n* person subject to court-ordered protection (curatorship, guardianship)\n* pregnant, parturient or breastfeeding woman\n* a person who is unable to consent\n* person on anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants (platelet function disorders)'}, 'identificationModule': {'nctId': 'NCT03773159', 'acronym': 'INDONESIA', 'briefTitle': 'Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions', 'orgStudyIdInfo': {'id': 'De MAISTRE ANR 2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs', 'interventionNames': ['Biological: Blood sampling']}, {'label': 'Controls', 'description': 'Blood donors at the French blood establishment in Burgundy Franche-Comté', 'interventionNames': ['Biological: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': '4 citrated/PPACK tubes and 1 EDTA tube maximum', 'armGroupLabels': ['Controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume MOUREY', 'role': 'CONTACT', 'email': 'guillaume.mourey@efs.sante.fr', 'phone': '03 81 61 56 15'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel De Maistre', 'role': 'CONTACT', 'email': 'emmanuel.demaistre@chu-dijon.fr', 'phone': '03 80 29 32 57'}], 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Emmanuel De Maistre', 'role': 'CONTACT', 'email': 'emmanuel.demaistre@chu-dijon.fr', 'phone': '03 81 61 56 15'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}