Clinical trial NCT02757235: The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma
Official title: The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma - A Multicenter Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: chronic subdural hematoma
irrigation
recurrence
burr hole evacuation
temperature
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Uppsala University Hospital
First posted: 2016-05-02
Enrollment: 588
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic subdural hematoma requiring burr hole evacuation.
* Patients older than 18 years of age.

Exclusion Criteria:

* Chronic subdural hematoma requiring surgical treatment other than burr hole evacuation.
* 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.

Primary outcomes:
measure: Recurrence rate
timeFrame: 6 months
Secondary outcomes:
measure: Mortality
timeFrame: 6 months
measure: Complications related to the surgery
timeFrame: 6 months
measure: Health related quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden
city: Solna
country: Sweden
facility: Karolinska University Hospital, Department of neurosurgery, Sweden
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Department of neurosurgery, Sweden
Study officials:
affiliation: Sahlgrenska University Hospital, Department of neurosurgery
name: Asgeir Jakola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Akademiska 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: Karolinska University Hospital, Department of neurosurgery
name: Jiri Bartek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska University Hospital, Department of neurosurgery
name: Andreas Bartley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska Universtiy Hospital, Department of neurosurgery
name: Magnus Tisell, MD, PhD
role: STUDY_DIRECTOR
affiliation: Karolinska University Hospital, Department of neurosurgery
name: Petter Förander, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.