Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT00124293
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2005-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2005-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2005-06-30', 'studyFirstSubmitQcDate': '2005-07-26', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11-23', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acquired Bleeding Disorder', 'Trauma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects were selected from a speciality practice group (Neurosurgery practices with a focus on head trauma. Subjects will have had a mild-to-moderate head injury and require hospitalization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages Eligible for Study: 18 Years - 85 Years'}, 'identificationModule': {'nctId': 'NCT00124293', 'briefTitle': 'Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multi Centre Observational Study to Evaluate the Incidence and Magnitude of Haemorrhagic Progression of Cerebral Contusions and the Identification of Important Safety Issues Following Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'F7CBI-1587'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Factor VII', 'interventionNames': ['Drug: activated recombinant human factor VII']}], 'interventions': [{'name': 'activated recombinant human factor VII', 'type': 'DRUG', 'armGroupLabels': ['Factor VII']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08536', 'city': 'Plainsboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.33344, 'lon': -74.60043}}, {'zip': 'L4W 4XI', 'city': 'Mississauga', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}