Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-26 @ 5:14 PM
Study NCT ID:
NCT02361294
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2015-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immature Plateletes in the Etiopathology of Deep Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'thrombophilia screening'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-10', 'studyFirstSubmitDate': '2015-02-06', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significantly increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.', 'timeFrame': 'at time of diagnosis'}], 'secondaryOutcomes': [{'measure': 'Significantly higher values of platelet function in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.', 'timeFrame': 'at time of diagnosis'}, {'measure': 'A persistently increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the controls three months after diagnosis.', 'timeFrame': '3 months after diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Immature Platelets', 'Deep Venous Thrombosis']}, 'descriptionModule': {'briefSummary': 'The study is designed to evaluate the role of platelets and immature platelets in the ethiopathology of deep venous thrombosis and pulmonary embolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all-comers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a newly diagnosed deep venous thrombosis and/or pulmonary embolism. The thrombembolism is idiopathic or caused by immobilisation.\n* Control: Patients that present with a suspicion of deep venous thrombosis which is excluded by duplex sonography.\n\nExclusion Criteria:\n\n* therapy with glycoprotein IIb/IIIa-antagonists within the last 10 days\n* therapy with antiplatelet drugs (ASA, Clopidogrel, Ticagrelor, Prasugrel, Dipyridamol)\n* preexisting anticoagulation\n* number of platelets \\< 100.000/µl\n* anemia (hematocrit \\< 35%, Hb \\< 10 g/dl)\n* age \\> 80 y or \\< 18 y\n* renal insufficiency GFR \\< 30 ml/min\n* hepatic impairment with an increased risk for bleeding or coagulopathy, or liver cirrhosis (≥ Child Pugh B)\n* intracranial or intracerebral bleeding within the last six months\n* intraspinal or intracerebral vascular anomalies\n* clinically relevant acute bleedings\n* malign disease\n* infections within the last 7 d\n* hematological, rheumatologic and autoimmune diseases\n* operations within the last six months\n* transfusion of rec celll concentrates within the last six months\n* transfusion of fresh frozen plasma or platelet concentrates within the last month\n* preexisting medication with CYP 3A4 inhibitors and inductors, p-glycoprotein inhibitors (Azol-Antimycotis, HIV protease-inhibitors)\n* hypersensitivity/contraindications for Rivaroxaban\n* pregnancy or lactation\n* thrombophilia\n* thrombocytopathy'}, 'identificationModule': {'nctId': 'NCT02361294', 'acronym': 'iPLATELET', 'briefTitle': 'Immature Plateletes in the Etiopathology of Deep Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Prospective Study to Generate Hypotheses About the Role of Platelets and Immature Platelets in the Pathogenesis of Idiopathic Venous Thromboses and Pulmonary Embolisms', 'orgStudyIdInfo': {'id': 'TechnischeUM 1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'Patients with a newly diagnosed deep venous thrombosis and/or pulmonary embolism. The thrombembolism is idiopathic or caused by immobilisation. Three blood samples are taken during the study period. A thrombophilia screening is carried out.', 'interventionNames': ['Other: Blood samples']}, {'label': 'Control', 'description': 'Patients that present with a suspicion of deep venous thrombosis which is excluded by duplex sonography. One to two blood samples are taken during the study period.', 'interventionNames': ['Other: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'OTHER', 'armGroupLabels': ['Control', 'Patient']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar, Technische Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Tareq Ibrahim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior consultant'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}