Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-07 @ 7:10 AM
Study NCT ID:
NCT03081169
Status:
WITHDRAWN
Last Update Posted:
2019-08-16
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of VTE Prophylaxis in TBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711671', 'term': 'enoxaparin sodium'}, {'id': 'D017984', 'term': 'Enoxaparin'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Recruitment not started due to potential conflicting study at same institution. May renew study in the future.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VTE', 'timeFrame': 'Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.', 'description': 'Rate of venous thromboembolism (DVT or PE)'}], 'secondaryOutcomes': [{'measure': 'Bleeding complications', 'timeFrame': 'Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.', 'description': 'Rate of expanding intracranial hemorrhage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TBI (Traumatic Brain Injury)', 'VTE (Venous Thromboembolism)']}, 'descriptionModule': {'briefSummary': 'This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis.', 'detailedDescription': 'This a randomized prospective study that compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients who are identified as having an intracranial injury will be randomized to early versus late VTE prophylaxis using a 1:1 random numbers allocation. Patients in both treatment groups will be monitored for development of VTE, primarily with scheduled duplex ultrasound studies of the lower extremities. Any clinical suspicion of VTE will also be investigated with duplex ultrasound and/or CT angiogram of the chest. Patients will be monitored for development of complications from bleeding post commencement of VTE prophylaxis. Intracranial bleeding complications will be monitored by physical examination and CT scanning of the head when indicated. Patients who undergo craniotomy or craniectomy will have VTE prophylaxis started 72 hours post-surgery and will undergo CT scan of the head (to assure bleeding stabilization) prior to administration of VTE prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic brain injury\n* Intracranial hemorrhage on CT scan\n\nExclusion Criteria:\n\n* Under the age of 18\n* Pregnant\n* Die within 24 hours of admission\n* Hospital stay less than 5 days\n* Contraindications to enoxaparin or heparin\n* Coagulopathy at 24 hours post-injury defined as INR\\>1.6 aPTT\\>2x normal, or platelet counts\\<50k\n* Known history of VTE'}, 'identificationModule': {'nctId': 'NCT03081169', 'briefTitle': 'Timing of VTE Prophylaxis in TBI', 'organization': {'class': 'OTHER', 'fullName': 'Loyola University'}, 'officialTitle': 'Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '209199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early (24 hours)', 'description': 'Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 24 hours after injury if CT head is stable.', 'interventionNames': ['Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe', 'Drug: Heparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late (72 hours)', 'description': 'Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 72 hours after injury if CT head is stable.', 'interventionNames': ['Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe', 'Drug: Heparin']}], 'interventions': [{'name': 'Enoxaparin Sodium 150 MG/ML Prefilled Syringe', 'type': 'DRUG', 'otherNames': ['Lovenox'], 'description': 'The same drugs and dosages will be used in both groups, with only the timing being different', 'armGroupLabels': ['Early (24 hours)', 'Late (72 hours)']}, {'name': 'Heparin', 'type': 'DRUG', 'description': 'The same drugs and dosages will be used in both groups, with only the timing being different', 'armGroupLabels': ['Early (24 hours)', 'Late (72 hours)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loyola University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Michael Anstadt', 'investigatorAffiliation': 'Loyola University'}}}}