Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-28 @ 7:14 PM
Study NCT ID:
NCT05713734
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2023-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bleeding of Unknown Cause: a Swiss Case-control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005342', 'term': 'Fibrinolysis'}], 'ancestors': [{'id': 'D001777', 'term': 'Blood Coagulation'}, {'id': 'D006487', 'term': 'Hemostasis'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma and EDTA samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibrin clot polymerisation', 'timeFrame': 'At inclusion', 'description': 'maximal absorption (optical density)'}, {'measure': 'Fibrin clot permeability', 'timeFrame': 'At inclusion', 'description': 'darcy coefficient (ks, cm2)'}, {'measure': 'Fibrinolysis', 'timeFrame': 'At inclusion', 'description': 'Clot lysis time (min)'}, {'measure': 'Thrombin generation', 'timeFrame': 'At inclusion', 'description': 'Endogenous thrombin potential (ETP, nM x min)'}, {'measure': 'Coated platelets', 'timeFrame': 'At inclusion', 'description': 'Absolute number of coated platelets'}], 'secondaryOutcomes': [{'measure': "Fibrinogen gamma' levels", 'timeFrame': 'At inclusion', 'description': "Ratio fibrinogen gamma'/total fibrinogen (%)"}, {'measure': 'Scan electron microscopy', 'timeFrame': 'At inclusion', 'description': 'Fibrin fiber diameter (nm)'}, {'measure': 'Clot retraction', 'timeFrame': 'At inclusion', 'description': 'Ratio clot weight/serum extruded (%)'}, {'measure': 'Plasmin generation', 'timeFrame': 'At inclusion', 'description': 'Plasmin (nM)'}, {'measure': 'Fibrin clot formation (thrombodynamics)', 'timeFrame': 'At inclusion', 'description': 'Initial rate of clot growth (μM/min)'}, {'measure': 'Major bleeding episodes', 'timeFrame': 'Three years', 'description': 'Incidence of major bleeding'}, {'measure': 'Non-major bleeding episodes', 'timeFrame': 'Three years', 'description': 'Incidence of clinically relevant non-major bleeding'}, {'measure': 'Health related quality of life', 'timeFrame': 'three years', 'description': 'SF36 questionnaire, 0 - 100 (high score, better outcome)'}, {'measure': 'International Society Thrombosis Hemostasis Bleeding assessment tool', 'timeFrame': 'three years', 'description': 'ISTH BAT score, 0 - 56 (high score, worse outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bleeding', 'Hemostatics', 'Fibrin', 'Fibrinolysis', 'Thrombin'], 'conditions': ['Bleeding Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective cohort is to identified specific biological patterns in patients with a bleeding of unknown cause and to study the specific mechanisms of the bleeding disorder for each subset of patients.', 'detailedDescription': 'Patients with bleeding of unknown cause are included. At baseline, blood will be drawn to evaluate the hemostatic profile. Findings are compared to a control group of healthy individuals. Patients and controls are followed for 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women and men aged 16-65 years who have been diagnosed as patients with bleeding of unknown cause Women and men aged 16-65 years without bleeding tendency', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man with ISTH BAT\\>3. If the calculated score includes a surgical bleeding, then two other items of the score should be \\>0\n* Woman with ISTH BAT \\>5 points. If the calculated score includes a surgical or a postpartum bleeding, then two other items of the score should be \\>0\n\nExclusion Criteria:\n\n* Ongoing pregnancy\n* Intake of antithrombotic treatment or non-steroidal anti-inflammatory drugs for least 10 days at time of blood collection\n* Intake of antifibrinolytic or blood product administration (factor concentrate, frozen fresh plasma, prothrombin complex concentrate) for least 14 days before blood collection\n* Active cancer (defined as cancer diagnosis within the last five years or treatment within the two last years before study inclusion)\n* Active autoimmune disease\n* Active chronic inflammatory disease\n* Severe liver disease (cirrhosis \\> Child A)\n* Renal insufficiency stage 3\n* Active or recent infection (within the last 30 days)\n* Recent hospitalization (\\<3 months)\n* Recent surgery (\\<3 months)\n* Recent trauma requiring medical intervention (\\<3 months)'}, 'identificationModule': {'nctId': 'NCT05713734', 'acronym': 'SWISS-BUC', 'briefTitle': 'Bleeding of Unknown Cause: a Swiss Case-control Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Bleeding of Unknown Cause, Insight Into a Multifactorial Bleeding Disorder: a Swiss Case-control Study', 'orgStudyIdInfo': {'id': 'CCER 2022-02121'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with bleeding of unknown cause', 'interventionNames': ['Diagnostic Test: Thrombin generation', 'Diagnostic Test: Fibrinolysis', 'Diagnostic Test: Fibrin clot structure', 'Diagnostic Test: Coated platelets']}, {'label': 'Controls', 'description': 'Healthy voluntaries without bleeding tendency', 'interventionNames': ['Diagnostic Test: Thrombin generation', 'Diagnostic Test: Fibrinolysis', 'Diagnostic Test: Fibrin clot structure', 'Diagnostic Test: Coated platelets']}], 'interventions': [{'name': 'Thrombin generation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of thrombin generation by ST Genesia', 'armGroupLabels': ['Controls', 'Patients']}, {'name': 'Fibrinolysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of fibrinolysis by Lysis Timer', 'armGroupLabels': ['Controls', 'Patients']}, {'name': 'Fibrin clot structure', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of fibrin polymerisation and permeability', 'armGroupLabels': ['Controls', 'Patients']}, {'name': 'Coated platelets', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of coated platelets by flow cytometry', 'armGroupLabels': ['Controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bellinzona', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Eugenia Biguzzi', 'role': 'CONTACT', 'email': 'eugenia.biguzzi@eoc.ch', 'phone': '+4191811886'}], 'facility': 'Ospedale Regionale di Bellinzona', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Ioannis Chanias', 'role': 'CONTACT', 'email': 'ioannis.chanias@insel.ch', 'phone': '+41316640852'}], 'facility': 'Inselspital - Universitätsspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Alessandro Casini', 'role': 'CONTACT'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Lorenzo Alberio', 'role': 'CONTACT', 'email': 'lorenzo.alberio@chuv.ch', 'phone': '+413143432'}], 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Lugano', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Ida Martinelli', 'role': 'CONTACT', 'email': 'Ida.Martinelli@moncucco.ch', 'phone': '+41919608666'}], 'facility': 'Gruppo Ospedaliero Moncucco', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'city': 'Sankt Gallen', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Lukas Graf', 'role': 'CONTACT', 'email': 'lukas.graf@zlmsg.ch', 'phone': '0041714941111'}], 'facility': 'Kantonsspital St.Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Jan-Dirk Studt', 'role': 'CONTACT', 'email': 'jan-dirk.studt@usz.ch', 'phone': '+41442553488'}], 'facility': 'USZ - Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Alessandro Casini', 'role': 'CONTACT', 'email': 'alessandro.casini@hcuge.ch', 'phone': '0041223729757'}], 'overallOfficials': [{'name': 'Alessandro Casini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals of Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Casini Alessandro', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}