Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT04391205
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2019-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Possible Causes of Secondary Effects During Use of Peripheral Midline Type Catheter in Patients Hospitalized in Different Care Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056824', 'term': 'Upper Extremity Deep Vein Thrombosis'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Peripheral deep venous thrombosis (DVP) suspected with Compression ultrasound (CUS) and confirmed by echodoppler', 'timeFrame': 'Once a week from the implant day until CVP removal or patient discharge, whichever came first, assessed up to 40 days', 'description': 'Deep vein thrombosis is investigated with Compression ultrasound (CUS) technique, scheduled once a week from the implant day or performed at the time of occurrence of device malfunctions or at the onset of symptoms resulting from thrombotic complications; echodoppler tecnique is used to confirm diagnosis of thrombosis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Midline', 'peripheral venous catheter', 'vascular access device', 'deep venous thrombosis'], 'conditions': ['Upper Extremity Deep Vein Thrombosis, Secondary']}, 'descriptionModule': {'briefSummary': 'Although the use of peripheral venous catheters (CVP) with brachial insertion with echo-guide (Midline) has increased significantly over the last 5-10 years, there are no sensitive data concerning complications in the literature during their use, particularly as regards incidence of thrombotic complication.The prospective observational study will enroll all the patients admitted to Home Health Hospitalization service, Geriatric Department and Intermediate Care service, to whom a Midline-type CVP will be placed for infusional therapy and who will give their consent to participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were recruited in 3 different settings in the Molinette Hospital (Turin) - Home Health Hospitalization service, Geriatric Department and Intermediate Care service.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects admitted to wards adhering to the study (Home Health Hospitalization service, Geriatric Department and Intermediate Care service)\n* Subjects submitted to Midline type venous catheter insertion\n\nExclusion Criteria:\n\n* History of deep venous thrombosis or pulmonary embolism\n* Be hospitalized for less than a week'}, 'identificationModule': {'nctId': 'NCT04391205', 'acronym': 'MIDES', 'briefTitle': 'A Study to Investigate the Possible Causes of Secondary Effects During Use of Peripheral Midline Type Catheter in Patients Hospitalized in Different Care Settings', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'Safety and Efficiency oh the Use of Midline Peripheral Venous Catheter (MIDES)', 'orgStudyIdInfo': {'id': '0041902'}}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'country': 'Italy', 'facility': 'Marinello Renata', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': 'Renata Marinello, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OAU Città della Salute e della Scienza di Torino, Turin, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dott.ssa RENATA MARINELLO', 'investigatorAffiliation': 'A.O.U. Città della Salute e della Scienza'}}}}