Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT01941602
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2013-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 979}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2013-09-02', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequencies of venous thromboembolism', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'frequencies of hematomas in need of reoperation or that significantly alters subsequent care', 'timeFrame': '30 days', 'description': 'frequencies of hematomas in need of reoperation or that significantly alters subsequent care (e.g. intensive care unit or other intensified treatment based on postoperative intracranial hemorrhage)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery', 'enoxaparin', 'venous thromboembolism', 'perioperative care'], 'conditions': ['Meningioma']}, 'referencesModule': {'references': [{'pmid': '26746334', 'type': 'RESULT', 'citation': 'Sjavik K, Bartek J Jr, Solheim O, Ingebrigtsen T, Gulati S, Sagberg LM, Forander P, Jakola AS. Venous Thromboembolism Prophylaxis in Meningioma Surgery: A Population-Based Comparative Effectiveness Study of Routine Mechanical Prophylaxis with or without Preoperative Low-Molecular-Weight Heparin. World Neurosurg. 2016 Apr;88:320-326. doi: 10.1016/j.wneu.2015.12.077. Epub 2015 Dec 31.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare different strategies for prevention of venous thromboembolism related to intracranial meningioma surgery. The investigators identified three hospitals where two have a very restrictive approach with respect to anticoagulant therapy while at the third hospital the use of anticoagulation the day before surgery was initiated as routine prophylaxis.\n\nBased on this "natural experiment" it will be explored whether the use of anticoagulant prophylaxis is associated with reduced risk of venous thromboembolism and/or associated with increased risk of postoperative hemorrhage as compared to the 2 cohorts where this intervention were absent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having had surgical treatment for intracranial meningioma in Norway (St Olavs University Hospital, Trondheim, and University Hospital North Norway, Tromsø) and Sweden (Karolinska University Hospital, Stockholm).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First included patient 1.january 2007 and latest included patient 1.july 2013 (allows for 30 day follow up with respect to morbidity)\n* Histological verification of a meningioma (of any grade) from the current surgery\n\nExclusion Criteria:\n\n* Intracranial surgery or venous thromboembolism the last 3 months'}, 'identificationModule': {'nctId': 'NCT01941602', 'briefTitle': 'A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'A Comparative Study of Prophylactic Enoxaparin Routinely Administered Preoperative for Prevention of Venous Thromboembolism in Meningioma Surgery - an Acceptable Risk-benefit Ratio?', 'orgStudyIdInfo': {'id': '2013/884'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'prophylactic', 'description': 'Prophylactic treatment with drugs to prevent venous thromboembolism in patients operated with open surgery for intracranial meningioma at the Department of neurosurgery at Karolinska Hospital, Stockholm, Sweden', 'interventionNames': ['Drug: prophylactic enoxaparin']}, {'label': 'non-prophylactic', 'description': 'No use of prophylactic treatment with drugs to prevent venous thromboembolism in patients operated with open surgery for intracranial meningioma at the Departments of neurosurgery at University Hospital North Norway (UNN) and St.Olavs University Hospital (Tromsø and Trondheim respectively, both Norway)', 'interventionNames': ['Procedure: non-prophylactic']}], 'interventions': [{'name': 'prophylactic enoxaparin', 'type': 'DRUG', 'description': 'enoxaparin had been prescribed at a dose of 40 mg (once daily) from the evening before surgery until patients were well mobilized. Also, at the time of surgery compression stockings were used, as well as a sequential compression device (SCD) until the morning after or longer if mobilization was delayed', 'armGroupLabels': ['prophylactic']}, {'name': 'non-prophylactic', 'type': 'PROCEDURE', 'description': 'no pharmacological prophylaxis for venous thromboembolism (VTE) had been used routinely. Occasionally, with delayed mobilization, a low-dose low molecular weight heparin (LMWH) had been prescribed. SCD had been used at increased frequency, and is today considered routine.', 'armGroupLabels': ['non-prophylactic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Lars Jacob Stovner, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St. Olavs Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, {'name': 'Karolinska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}