The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma
NCT ID: NCT02757235
Last Updated: 2022-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
588 participants
INTERVENTIONAL
2016-03-31
2020-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Irrigation fluid of body temperature
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 body temperature
Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma
Irrigation fluid of room temperature
During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of room temperature (approximately 22 degrees Celsius)
Irrigation fluid of room temperature
Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.
Interventions
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Irrigation fluid of body temperature
Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma
Irrigation fluid of room temperature
Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.
Eligibility Criteria
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Inclusion Criteria
* Patients older than 18 years of age.
Exclusion Criteria
* Chronic subdural hematoma in a patient with an intracranial arachnoidal cyst.
* Chronic subdural hematoma in a patient with a Cerebro Spinal Fluid-shunt.
* Patients who have undergone intracranial surgery before.
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Uppsala University Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Responsible Party
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Andreas Bartley
MD, neurosurgical resident
Principal Investigators
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Asgeir Jakola, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital, Department of neurosurgery
Niklas Marklund, MD, Phd
Role: PRINCIPAL_INVESTIGATOR
Akademiska University Hospital, Department of neurosurgery
Jimmy Sundblom, MD, Phd
Role: PRINCIPAL_INVESTIGATOR
Akademiska University Hospital, Department of neurosurgery
Jiri Bartek, MD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital, Department of neurosurgery
Andreas Bartley, MD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital, Department of neurosurgery
Magnus Tisell, MD, PhD
Role: STUDY_DIRECTOR
Sahlgrenska Universtiy Hospital, Department of neurosurgery
Petter Förander, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital, Department of neurosurgery
Locations
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Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden
Gothenburg, , Sweden
Karolinska University Hospital, Department of neurosurgery, Sweden
Solna, , Sweden
Uppsala University Hospital, Department of neurosurgery, Sweden
Uppsala, , Sweden
Countries
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References
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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.
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.
Other Identifiers
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SIC01
Identifier Type: -
Identifier Source: org_study_id
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