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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: Irrigation fluid of body temperature; Procedure: Irrigation fluid of room temperature

• Study Type: Interventional
• Enrollment (Actual): 588
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 41345
    • Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden
  • Solna, Sweden, 17164
    • Karolinska University Hospital, Department of neurosurgery, Sweden
  • Uppsala, Sweden, 75309
    • Uppsala University Hospital, Department of neurosurgery, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Irrigation fluid of body temperature; During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of body temperature (approximately 37 degrees Celsius)	Procedure: Irrigation fluid of body temperature; Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma
ACTIVE_COMPARATOR: Irrigation fluid of room temperature; During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of room temperature (approximately 22 degrees Celsius)	Procedure: Irrigation fluid of room temperature; Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	The proportion deceased at a given time during the 6 month follow up.	6 months
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
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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Karolinska University Hospital; Uppsala University Hospital
• Investigators: Principal Investigator: Asgeir Jakola, MD, PhD, Sahlgrenska University Hospital, Department of neurosurgery; Principal Investigator: Niklas Marklund, MD, Phd, Akademiska University Hospital, Department of neurosurgery; Principal Investigator: Jimmy Sundblom, MD, Phd, Akademiska University Hospital, Department of neurosurgery; Principal Investigator: Jiri Bartek, MD, Karolinska University Hospital, Department of neurosurgery; Principal Investigator: Andreas Bartley, MD, Sahlgrenska University Hospital, Department of neurosurgery; Study Director: Magnus Tisell, MD, PhD, Sahlgrenska Universtiy Hospital, Department of neurosurgery; Principal Investigator: Petter Förander, MD, PhD, Karolinska University Hospital, Department of neurosurgery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): October 20, 2020

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (ESTIMATE): May 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: temperature; recurrence; chronic subdural hematoma; irrigation; burr hole evacuation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: SIC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES