Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:10 PM
Study NCT ID:
NCT00915928
Status:
TERMINATED
Last Update Posted:
2020-08-19
First Post:
2009-06-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}], 'ancestors': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020913', 'term': 'Perindopril'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'frantz.r.poulsen@rsyd.dk', 'phone': '0045 65413600', 'title': 'Frantz Rom Poulsen, Professor, consultant', 'organization': 'Odense University Hospital, Odense, Denmark'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'Low dose of a well tolerated and well known drug in the active drug arm', 'eventGroups': [{'id': 'EG000', 'title': 'ACE Inhibitor', 'description': 'Active compound', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Inactive placebo', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '2.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Size of Chronic Subdural Hematoma (CSDH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACE Inhibitor', 'description': 'Perindopril: 2,5 mg daily for 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'spread': '5', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composition of Chronic Subdural Hematoma Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Composition of Chronic Subdural Hematoma Fluid', 'description': 'Biochemical analysis of CSDH fluid content. This analysis will not be performed due to insufficient funding'}], 'timeFrame': 'years', 'description': 'Post-Hoc Outcome Measure', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis will not be performed due to insufficient funding and the samples will be destroyed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACE Inhibitor', 'description': 'Perindopril: 2,5 mg daily for 3 months'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Neurosurgical clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'three months placebo treatment after surgical CSDH evacuation'}, {'id': 'BG001', 'title': 'Perindopril', 'description': 'three months perindopril treatment after surgical CSDH evacuation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '5', 'groupId': 'BG000'}, {'value': '64.3', 'spread': '5', 'groupId': 'BG001'}, {'value': '67.2', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'CSDH and indication for surgical evacuation', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Prospective, randomized', 'unitOfMeasure': 'participants', 'populationDescription': 'Many patients were not able to consent and the neurosurgeon on call were too busy to include in the project'}, {'title': 'Size of Chronic Subdural Hematoma', 'classes': [{'categories': [{'measurements': [{'value': '130', 'spread': '10', 'groupId': 'BG000'}, {'value': '124', 'spread': '10', 'groupId': 'BG001'}, {'value': '127', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^3', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Patients with CSDH and indication for surgery. Either male or female'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'whyStopped': 'No effect of the ACE inhibitor evaluated halfway in the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2009-06-03', 'resultsFirstSubmitDate': '2020-08-14', 'studyFirstSubmitQcDate': '2009-06-04', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-18', 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size of Chronic Subdural Hematoma (CSDH)', 'timeFrame': '3 months', 'description': 'Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans'}], 'secondaryOutcomes': [{'measure': 'Composition of Chronic Subdural Hematoma Fluid', 'timeFrame': 'years', 'description': 'Post-Hoc Outcome Measure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hematoma, Subdural, Chronic']}, 'descriptionModule': {'briefSummary': 'The project aims at investigating if treatment with the Angiotensin Converting Enzyme inhibitor Coversyl (perindopril) for 3 months after surgery for chronic subdural hematoma will decrease the risc of recurrence.', 'detailedDescription': 'Previous studies have indicated that treatment with ACE inhibitors can reduce the risk of recurrence of CSDH after surgical evacuation. This randomized clinical trial was designed to investigate this'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with chronic subdural hematoma that needs surgical evacuation\n2. Age \\> 18 year\n\nExclusion Criteria:\n\n1. Lack of compliance\n2. Kidney artery stenosis\n3. Stenosis of the aorta\n4. Severely decreased kidney function\n5. Allergy or intolerance/contraindications toward ACE inhibitors\n6. Already in ACE inhibitor treatment\n7. Coagulopathies\n8. Malignant disorders\n9. Fertile women\n10. Other neurological disorders\n11. Treatment with pharmaceuticals contraindicating treatment with ACE inhibitors'}, 'identificationModule': {'nctId': 'NCT00915928', 'acronym': 'KSDH', 'briefTitle': 'Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors', 'orgStudyIdInfo': {'id': 'Chronic Subdural Hematoma'}, 'secondaryIdInfos': [{'id': 'Eudra CT nummer 2009-010058-37'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACE inhibitor', 'description': 'patients randomized to this arm will be treated with ACE inhibitors after surgery', 'interventionNames': ['Drug: Perindopril']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'patients randomized to this arm will be treated with placebo after surgery', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Perindopril', 'type': 'DRUG', 'otherNames': ['coversyl'], 'description': '2,5 mg daily for 3 months', 'armGroupLabels': ['ACE inhibitor']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo dayli for 3 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frantz R Poulsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alice Brenaa Foundation', 'class': 'OTHER'}, {'name': 'The Hede Nielsen Family Foundation', 'class': 'OTHER'}, {'name': 'Overlægerådets legatudvalg', 'class': 'UNKNOWN'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Frantz Rom Poulsen', 'investigatorAffiliation': 'Odense University Hospital'}}}}