Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT05609734
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2022-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
No Cases of Delayed Intracranial Hemorrhage (d-ICH) Among Patients With Mild Traumatic Brain Injury (mTBI) on Oral Anticoagulation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001930', 'term': 'Brain Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'CT scans, patient journals and bloodsample results, no bloodsamples were saved for further analysizes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2022-10-14', 'studyFirstSubmitQcDate': '2022-11-01', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delayed traumatic intracranial hemorrhage', 'timeFrame': '6 hours', 'description': 'Inclusion criteria was mTBI and pre-injury anticoagulation or SGA therapy. A secondary CT scan was performed 6 hours later, to detect a delayed intracranial hemorrhage.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antithrombotic therapy'], 'conditions': ['Traumatic Intracranial Hemorrhage', 'Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'Abstract Purpose Patients with anticoagulation therapy has a higher risk of developing traumatic Intracranial Hemorrhage (tICH). Delayed Intracranial Hemorrhage (d-ICH) is a rarer clinical manifestation; however, the incidence varies from 0-9,6 % in other studies. Some studies have also questioned the clinical relevance of d-ICH, since the mortality and the need of neurosurgical intervention is reported to be very low. The aim of this study is to determine the incidence of d-ICH at Sundsvall Regional Hospital.\n\nMethods A retrospective observational study of patients with mTBI and oral anticoagulation therapy. Data from medical records and radiology registry in Sundsvall hospital for 29 months during 2018-2020 in Sundsvall identified 249 patients with an initial negative CT scan who performed a follow-up CT scan. Outcome measure was incidence of d-ICH.', 'detailedDescription': 'Method This is a retrospective observational study investing the incidence of d-ICH at Sundsvall Regional Hospital. Data was collected from 2018-01-01 - 2020-05-30, and all data collection followed a predetermined protocol. Data was collected by two persons.\n\nStarting from the hospital\'s radiology registry, all CT-scan referrals from emergency departments surgical section and acute surgical ward with a possible traumatic brain injury was read. Hereafter patients\' journals were used to retrieve mechanism of injury, pre-injury medications, and arrival status.\n\nTBI are typically classified after level of consciousness, internationally often measures in Glasgow Coma Scale (GCS) (3). At Sundsvall Regional Hospital, RLS (Reaction Level Scale) is more commonly used, hence it was used in data collection. However, in most cases patients\' mental status was only commented as "unaffected" without any use of neither GCS nor RLS. In statistical analysis, we only recorded RLS where it was in clear print and choose not to translate "unaffected" into RLS 1. RLS 1 and GCS 15 are comparable, and GCS 14 and RLS2 are also comparable. mTBI is classified by Scandinavian Neurotrauma Committee\'s guidelines as a GCS 14 after head trauma, or GCS 15 after head trauma in combination with loss of consciousness, repeated vomiting, posttraumatic seizures, focal neurological deficits, signs of skull fracture, intracranial shunts, antithrombotic treatment, or antiplatelet treatment in combination with age over 65.\n\nInclusion criteria was mTBI and pre-injury anticoagulation or SGA therapy. In the initial data collection, all patients with mTBI regardless of antitrombotic therapy status were included for comparison for another study. Exclusion criteria was high energy trauma, age \\<18 years, concealed journals, spontaneous hemorrhage, RLS ≥3 (Figure 1). Due to the lack of control CT, patients on solely ASA or LMWH was also excluded due to former local clinical guidelines.\n\nHigh energy trauma was excluded from this study, due to the heterogenous variety of injuries and often multiple organ injuries. High energy trauma was defined as any traffic accident or fall \\> 3 meters, or other traumas that required acute trauma care at the emergency trauma room.\n\ntICH was subcategorized into subdural hemorrhage (SDH), subarachnoid hemorrhage (SAH), epidural hemorrhage or others. Age and gender were collected as demographic data. Severity of head trauma, treatment with anticoagulation therapy (DOAC/VKA/LMWH/other) and/or antiplatelet therapy (ASA/Clopidogrel/Ticagrelor/other) were noted. Antithrombotic therapy was used as an overall term compromising both anticoagulation and antiplatelet treatment. The predominant SGA used for single therapy in Sweden is Clopidogrel, and no participants in this study had single therapy with Ticagrelor. SGA is therefore synonymous with Clopidogrel in this study.\n\nUnclear formulations, positive findings or uncertain findings in the initial radiology assessment was held to a second opinion by an experienced neuroradiologist. A total of 3 cases (1,2 %) were held to a second opinion assessment (Table 1).\n\nStatistics Statistical analysis was executed using Microsoft Excel® version 2108 for Microsoft Windows®. Demographic data were presented as means and standard deviations (SD), or as counts and percentage where appropriate.\n\nThe sample size was set to a period of 29 months from January 2018 to May 2020, by which we estimated by the study supervisors to match comparable studies in the field, thus no power calculation prior to study start was done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "This is a retrospective observational study investing the incidence of d-ICH at Sundsvall Regional Hospital. Data was collected from 2018-01-01 - 2020-05-30, and all data collection followed a predetermined protocol. Data was collected by two persons.\n\nStarting from the hospital's radiology registry, all CT-scan referrals from emergency departments surgical section and acute surgical ward with a possible traumatic brain injury was read. Hereafter patients' journals were used to retrieve mechanism of injury, pre-injury medications, and arrival status.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria was mTBI and pre-injury anticoagulation or SGA therapy. In the initial data collection, all patients with mTBI regardless of antitrombotic therapy status were included for comparison for another study.\n\nExclusion Criteria:\n\n* Exclusion criteria was high energy trauma, age \\<18 years, concealed journals, spontaneous hemorrhage, RLS ≥3 (Figure 1). Due to the lack of control CT, patients on solely ASA or LMWH was also excluded due to former local clinical guidelines.'}, 'identificationModule': {'nctId': 'NCT05609734', 'briefTitle': 'No Cases of Delayed Intracranial Hemorrhage (d-ICH) Among Patients With Mild Traumatic Brain Injury (mTBI) on Oral Anticoagulation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'No Cases of Delayed Intracranial Hemorrhage (d-ICH) Among Patients With Mild Traumatic Brain Injury (mTBI) on Oral Anticoagulation Therapy', 'orgStudyIdInfo': {'id': '20HSN3790 nr2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with an delayed traumatic intracranial hemorrhage', 'description': 'A total of 249 control CTs was performed, where the initial CT was normal regarding tICH. In the initial assessments 1 case of d-ICH (0,41%) was found, but after second opinion this case (case 1, Table 1) was regarded as a pictorial artefact (Table 1). Hence, no d-ICH was found.', 'interventionNames': ['Other: no intervention, only observational retrospective study']}, {'label': 'Patients without an delayed traumatic intracranial hemorrhage', 'description': 'A total of 249 control CTs was performed, where the initial CT was normal regarding tICH. In the initial assessments 1 case of d-ICH (0,41%) was found, but after second opinion this case (case 1, Table 1) was regarded as a pictorial artefact (Table 1). Hence, no d-ICH was found.', 'interventionNames': ['Other: no intervention, only observational retrospective study']}], 'interventions': [{'name': 'no intervention, only observational retrospective study', 'type': 'OTHER', 'description': 'no intervention, only observational retrospective study', 'armGroupLabels': ['Patients with an delayed traumatic intracranial hemorrhage', 'Patients without an delayed traumatic intracranial hemorrhage']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sundsvall', 'country': 'Sweden', 'facility': 'Sundsvall Hospital', 'geoPoint': {'lat': 62.39129, 'lon': 17.3063}}], 'overallOfficials': [{'name': 'Yücel Cengiz, Ph.D. M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Umea University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}