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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Uppsala University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irrigation fluid of body temperature | Active Comparator | During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of body temperature (approximately 37 degrees Celsius) |
|
| Irrigation fluid of room temperature | Active Comparator | During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of room temperature (approximately 22 degrees Celsius) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irrigation fluid of body temperature | Procedure | Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Recurrences requiring repeat surgery during a 6-month follow up period | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | The proportion deceased at a given time during the 6 month follow up. | 6 months |
| Complications related to the surgery | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asgeir Jakola, MD, PhD | Sahlgrenska University Hospital, Department of neurosurgery | Principal Investigator |
| Niklas Marklund, MD, Phd | Akademiska University Hospital, Department of neurosurgery | Principal Investigator |
| Jimmy Sundblom, MD, Phd | Akademiska University Hospital, Department of neurosurgery | Principal Investigator |
| Jiri Bartek, MD | Karolinska University Hospital, Department of neurosurgery | Principal Investigator |
| Andreas Bartley, MD | Sahlgrenska University Hospital, Department of neurosurgery | Principal Investigator |
| Magnus Tisell, MD, PhD | Sahlgrenska Universtiy Hospital, Department of neurosurgery | Study Director |
| Petter Förander, MD, PhD | Karolinska University Hospital, Department of neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden | Gothenburg | 41345 | Sweden | |||
| Karolinska University Hospital, Department of neurosurgery, Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36409480 | Derived | 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. | |
| 29021000 | Derived |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| Irrigation fluid of room temperature | Procedure | Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma. |
|
| 6 months |
| Health related quality of life | 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. | 6 months |
| Solna |
| 17164 |
| Sweden |
| Uppsala University Hospital, Department of neurosurgery, Sweden | Uppsala | 75309 | Sweden |
| 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. |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |