The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma

Chronic Subdural Hematoma Clinical Trial

— SIC!  

Official title:

The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma - A Multicenter Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757235
• Other study ID #: SIC01
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 20, 2020

Study information

• Verified date: February 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: October 20, 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Sweden	Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden	Göteborg
Sweden	Karolinska University Hospital, Department of neurosurgery, Sweden	Solna
Sweden	Uppsala University Hospital, Department of neurosurgery, Sweden	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Karolinska University Hospital, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate	Recurrences requiring repeat surgery during a 6-month follow up period	6 months
Secondary	Mortality	The proportion deceased at a given time during the 6 month follow up.	6 months
Secondary	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).	6 months
Secondary	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