The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma (SIC!)

Sahlgrenska University Hospital

Status: Completed

Conditions: Chronic Subdural Hematoma

Treatments: Procedure: Irrigation fluid of body temperature; Procedure: Irrigation fluid of room temperature

Study type: Interventional

Funder types: Other

Identifiers

NCT02757235

SIC01

Details and patient eligibility

About

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.

Enrollment: 588 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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588 participants in 2 patient groups

Irrigation fluid of body temperature

Active Comparator group

Description:

During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of body temperature (approximately 37 degrees Celsius)

Treatment:

Procedure: Irrigation fluid of body temperature

Irrigation fluid of room temperature

Active Comparator group

Description:

During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of room temperature (approximately 22 degrees Celsius)

Treatment:

Procedure: Irrigation fluid of room temperature