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

Primary Purpose

Chronic Subdural Hematoma

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Irrigation fluid of body temperature
Irrigation fluid of room temperature
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring chronic subdural hematoma, irrigation, recurrence, burr hole evacuation, temperature

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden
  • Karolinska University Hospital, Department of neurosurgery, Sweden
  • Uppsala University Hospital, Department of neurosurgery, Sweden

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Irrigation fluid of body temperature

Irrigation fluid of room temperature

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recurrence rate
Recurrences requiring repeat surgery during a 6-month follow up period

Secondary Outcome Measures

Mortality
The proportion deceased at a given time during the 6 month follow up.
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).
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.

Full Information

First Posted
April 28, 2016
Last Updated
February 25, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Karolinska University Hospital, Uppsala University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02757235
Brief Title
The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma
Acronym
SIC!
Official Title
The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma - A Multicenter Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Karolinska University Hospital, Uppsala University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
chronic subdural hematoma, irrigation, recurrence, burr hole evacuation, temperature

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
588 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irrigation fluid of body temperature
Arm Type
Active Comparator
Arm Description
During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of body temperature (approximately 37 degrees Celsius)
Arm Title
Irrigation fluid of room temperature
Arm Type
Active Comparator
Arm Description
During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of room temperature (approximately 22 degrees Celsius)
Intervention Type
Procedure
Intervention Name(s)
Irrigation fluid of body temperature
Intervention Description
Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma
Intervention Type
Procedure
Intervention Name(s)
Irrigation fluid of room temperature
Intervention Description
Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.
Primary Outcome Measure Information:
Title
Recurrence rate
Description
Recurrences requiring repeat surgery during a 6-month follow up period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mortality
Description
The proportion deceased at a given time during the 6 month follow up.
Time Frame
6 months
Title
Complications related to the surgery
Description
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).
Time Frame
6 months
Title
Health related quality of life
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asgeir Jakola, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Department of neurosurgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niklas Marklund, MD, Phd
Organizational Affiliation
Akademiska University Hospital, Department of neurosurgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jimmy Sundblom, MD, Phd
Organizational Affiliation
Akademiska University Hospital, Department of neurosurgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiri Bartek, MD
Organizational Affiliation
Karolinska University Hospital, Department of neurosurgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Bartley, MD
Organizational Affiliation
Sahlgrenska University Hospital, Department of neurosurgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Magnus Tisell, MD, PhD
Organizational Affiliation
Sahlgrenska Universtiy Hospital, Department of neurosurgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Petter Förander, MD, PhD
Organizational Affiliation
Karolinska University Hospital, Department of neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Karolinska University Hospital, Department of neurosurgery, Sweden
City
Solna
ZIP/Postal Code
17164
Country
Sweden
Facility Name
Uppsala University Hospital, Department of neurosurgery, Sweden
City
Uppsala
ZIP/Postal Code
75309
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
29021000
Citation
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.
Results Reference
derived

Learn more about this trial

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

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