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

S

Sahlgrenska University Hospital

Status

Completed

Conditions

Chronic Subdural Hematoma

Treatments

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

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

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems