Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 5:57 PM
Study NCT ID:
NCT04748393
Status:
TERMINATED
Last Update Posted:
2021-02-10
First Post:
2019-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Low enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-06', 'studyFirstSubmitDate': '2019-08-14', 'studyFirstSubmitQcDate': '2021-02-06', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary objective', 'timeFrame': '3-month follow-up', 'description': 'Rate of new-onset abnormal menstrual bleeding (PBAC \\>100 ml), and its impact on quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menorrhagia', 'anticoagulation'], 'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '35925686', 'type': 'DERIVED', 'citation': 'de Jong CMM, Blondon M, Ay C, Buchmuller A, Beyer-Westendorf J, Biechele J, Bertoletti L, Colombo G, Donadini MP, Hendriks SV, Jara-Palomares L, Nopp S, Ruiz-Artacho P, Stephan P, Tromeur C, Vanassche T, Westerweel PE, Klok FA. Incidence and impact of anticoagulation-associated abnormal menstrual bleeding in women after venous thromboembolism. Blood. 2022 Oct 20;140(16):1764-1773. doi: 10.1182/blood.2022017101.'}]}, 'descriptionModule': {'briefSummary': 'This study is an international, multicenter, academically sponsored, observational study, that focusses on fertile female patients with proven symptomatic deep vein thrombosis of the legs (DVT) or acute pulmonary embolism (PE). The incidence and severity of abnormal menstrual bleeding will be assessed for each menstrual period and correlated to quality of life. Causes of abnormal menstrual bleeding other than active anticoagulant treatment will be assessed. Treatment of abnormal menstrual bleeding (all within routine clinical care) will be evaluated for efficacy and safety.', 'detailedDescription': 'A recently performed international survey of expert opinion and current practice revealed divergent expert recommendations and very heterogeneous management approach in clinical practice with regard to anticoagulation choice, use of HC and treatment of abnormal uterine bleeding during anticoagulant treatment of VTE. Together with the fact that up to 70% of female patients with childbearing potential treated with anticoagulants may suffer from abnormal menstrual bleeding with a severe negative impact on quality of life, this is a compelling argument to initiate high quality observational studies to better quantify the magnitude of the problem and to identify unmet clinical needs. This study will do so and at the same time provide solid ground for future prospective management trials aimed at establishing preventive and/or treatment strategies for VTE patients with anticoagulant-associated abnormal menstrual bleeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive female patients between the ages of 18 and 50 with child bearing potential and objectivated, symptomatic VTE, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion.', 'genderDescription': 'female patients within their fertile age, diagnosed with acute venous thromboembolism', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability of subject to understand the character and individual consequences of this clinical study;\n2. Signed and dated informed consent of the subject available before the start of any specific study procedures;\n3. Age ≥18 years and ≤ 50 years;\n4. Confirmed symptomatic first or recurrent VTE;\n\n 1. DVT: incompressibility of proximal or distal veins of the affected leg by compression ultrasonography or venous filling defect on multi-detector computed tomography venography. The diagnosis of ipsilateral recurrent DVT is defined as a CUS that shows incompressibility of a different venous segment than at the reference CUS examination, or in case of a pronounced increase in vein diameter (≥4 mm) of a previous non-compressible venous segment, or by an abnormal signal of Magnetic resonance direct thrombus imaging (MRDTI);\n 2. PE: both first and recurrent PE are diagnosed in case of at least one filling defect in the pulmonary artery tree on multi-detector computed tomography pulmonary angiography (CTPA) up to the subsegmental level, or high probability result of ventilation perfusion scintigraphy;\n5. Childbearing potential, i.e. with active menstrual cycle with or without hormonal regulation of any kind initiated for reasons of either contraception or for treatment of abnormal menstrual bleeding;\n6. Inclusion before the first day of next menstrual cycle after VTE diagnosis or within 1 month after the VTE diagnosis, whichever comes first.\n\nExclusion Criteria:\n\n1. Woman between the ages of 18 and 50 who were subjected to hysterectomy or chemically induced menopause;\n2. Woman between the ages of 18 and 50 with premature menopause (established before study inclusion);\n3. Planned treatment with parenteral anticoagulation (and no switch to oral drugs);\n4. Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 6 months, or unwillingness to sign informed consent;\n5. Non-compliance or inability to adhere to the follow-up visits;\n6. Pregnancy or post-partum (first three months) associated VTE;\n7. Active in vitro fertilization (IVF) treatment or planned IVF treatment during the study period.'}, 'identificationModule': {'nctId': 'NCT04748393', 'acronym': 'TEAM-VTE', 'briefTitle': 'Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding in Female Patients With VTE', 'orgStudyIdInfo': {'id': 'LUMC2017132'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study cohort', 'description': 'Consecutive female patients between the ages of 18 and 50 with child bearing potential and objectivated, symptomatic VTE, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Brest', 'country': 'France', 'facility': 'Hôpital de la Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'University Medical Centre Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospital', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's & St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'F.A. Klok', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LUMC Leiden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Erik Klok', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}