Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-18 @ 9:59 PM
Study NCT ID:
NCT02757235
Status:
COMPLETED
Last Update Posted:
2022-02-28
First Post:
2016-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 588}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2016-04-28', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': '6 months', 'description': 'Recurrences requiring repeat surgery during a 6-month follow up period'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6 months', 'description': 'The proportion deceased at a given time during the 6 month follow up.'}, {'measure': 'Complications related to the surgery', 'timeFrame': '6 months', 'description': 'Complications will be assessed using the Landriel Ibanez classification modelThis model grades complications in 4 grades (Grade 1: no invasive treatment required; Grade 2: invasive treatment required, but not intensive care; Grade 3: invasive treatment required and intensive care; Grade 4: death).'}, {'measure': 'Health related quality of life', 'timeFrame': '6 months', 'description': 'A standardised instrument, EuroQoL 5D-3L, will be used as a generic measure of health related quality of life. The questionnaire contains 5 questions in different domains.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic subdural hematoma', 'irrigation', 'recurrence', 'burr hole evacuation', 'temperature'], 'conditions': ['Chronic Subdural Hematoma']}, 'referencesModule': {'references': [{'pmid': '36409480', 'type': 'DERIVED', 'citation': 'Bartley A, Bartek J Jr, Jakola AS, Sundblom J, Falt M, Forander P, Marklund N, Tisell M. Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma: A Randomized Clinical Trial. JAMA Neurol. 2023 Jan 1;80(1):58-63. doi: 10.1001/jamaneurol.2022.4133.'}, {'pmid': '29021000', 'type': 'DERIVED', 'citation': 'Bartley A, Jakola AS, Bartek J Jr, Sundblom J, Forander P, Marklund N, Tisell M. The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial. Trials. 2017 Oct 11;18(1):471. doi: 10.1186/s13063-017-2194-y.'}]}, 'descriptionModule': {'briefSummary': 'The study will be a multicenter randomised controlled trial of the use of irrigation fluid of body temperature versus irrigation fluid of room temperature during burr hole evacuation of chronic subdural hematoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic subdural hematoma requiring burr hole evacuation.\n* Patients older than 18 years of age.\n\nExclusion Criteria:\n\n* Chronic subdural hematoma requiring surgical treatment other than burr hole evacuation.\n* Chronic subdural hematoma in a patient with an intracranial arachnoidal cyst.\n* Chronic subdural hematoma in a patient with a Cerebro Spinal Fluid-shunt.\n* Patients who have undergone intracranial surgery before.'}, 'identificationModule': {'nctId': 'NCT02757235', 'acronym': 'SIC!', 'briefTitle': 'The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma - A Multicenter Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'SIC01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Irrigation fluid of body temperature', 'description': 'During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of body temperature (approximately 37 degrees Celsius)', 'interventionNames': ['Procedure: Irrigation fluid of body temperature']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Irrigation fluid of room temperature', 'description': 'During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of room temperature (approximately 22 degrees Celsius)', 'interventionNames': ['Procedure: Irrigation fluid of room temperature']}], 'interventions': [{'name': 'Irrigation fluid of body temperature', 'type': 'PROCEDURE', 'description': 'Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma', 'armGroupLabels': ['Irrigation fluid of body temperature']}, {'name': 'Irrigation fluid of room temperature', 'type': 'PROCEDURE', 'description': 'Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.', 'armGroupLabels': ['Irrigation fluid of room temperature']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '17164', 'city': 'Solna', 'country': 'Sweden', 'facility': 'Karolinska University Hospital, Department of neurosurgery, Sweden', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'zip': '75309', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital, Department of neurosurgery, Sweden', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Asgeir Jakola, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital, Department of neurosurgery'}, {'name': 'Niklas Marklund, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akademiska University Hospital, Department of neurosurgery'}, {'name': 'Jimmy Sundblom, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akademiska University Hospital, Department of neurosurgery'}, {'name': 'Jiri Bartek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital, Department of neurosurgery'}, {'name': 'Andreas Bartley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital, Department of neurosurgery'}, {'name': 'Magnus Tisell, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sahlgrenska Universtiy Hospital, Department of neurosurgery'}, {'name': 'Petter Förander, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital, Department of neurosurgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska University Hospital', 'class': 'OTHER'}, {'name': 'Uppsala University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, neurosurgical resident', 'investigatorFullName': 'Andreas Bartley', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}