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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02757235

Acronym

SIC!

Enrollment

588

Registered

2016-05-02

Start date

2016-03-31

Completion date

2020-10-20

Last updated

2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Subdural Hematoma

Keywords

chronic subdural hematoma, irrigation, recurrence, burr hole evacuation, temperature

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.

Interventions

PROCEDUREIrrigation fluid of body temperature

Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma

PROCEDUREIrrigation fluid of room temperature

Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Recurrence rate	6 months	Recurrences requiring repeat surgery during a 6-month follow up period

Secondary

Measure	Time frame	Description
Mortality	6 months	The proportion deceased at a given time during the 6 month follow up.
Complications related to the surgery	6 months	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).
Health related quality of life	6 months	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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026