Chronic Subdural HematomaSIC!NCT02757235
The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma
A study testing Irrigation fluid of body temperature and Irrigation fluid of room temperature in people with Chronic Subdural Hematoma, run by Sahlgrenska University Hospital at 3 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Irrigation fluid of body temperature and Irrigation fluid of room temperature
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 3 sitesSweden
- Study dates
- Mar 2016to 20 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic subdural hematoma requiring burr hole evacuation.
- Patients older than 18 years of age.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Sweden3 sites
Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden
Gothenburg, 41345
Karolinska University Hospital, Department of neurosurgery, Sweden
Solna, 17164
Uppsala University Hospital, Department of neurosurgery, Sweden
Uppsala, 75309
About this study
Official title: 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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Irrigation fluid of body temperature, Irrigation fluid of room temperature
- Keywords
- chronic subdural hematoma, irrigation, recurrence, burr hole evacuation, temperature
- Medical subject headings
- Hematoma, Subdural, Chronic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation fluid of body temperatureProcedure or surgery
Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma
Irrigation fluid of room temperatureProcedure or surgery
Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.
| Study group | Role | What they receive |
|---|---|---|
| Irrigation fluid of body temperature | Active comparator | During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of body temperature (approximately 37 degrees Celsius) Receives: Procedure: Irrigation fluid of body temperature |
| Irrigation fluid of room temperature | Active comparator | During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of room temperature (approximately 22 degrees Celsius) Receives: Procedure: Irrigation fluid of room temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Recurrences requiring repeat surgery during a 6-month follow up period
Measured: 6 months
Secondary outcomes (3)
Mortality
The proportion deceased at a given time during the 6 month follow up.
Measured: 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).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Uppsala University Hospital
- Responsible party
- Principal investigator, Andreas Bartley, Sahlgrenska University Hospital
- Investigators
- Asgeir Jakola, MD, PhD, Principal investigator, Sahlgrenska University Hospital, Department of neurosurgeryNiklas Marklund, MD, Phd, Principal investigator, Akademiska University Hospital, Department of neurosurgeryJimmy Sundblom, MD, Phd, Principal investigator, Akademiska University Hospital, Department of neurosurgeryJiri Bartek, MD, Principal investigator, Karolinska University Hospital, Department of neurosurgeryAndreas Bartley, MD, Principal investigator, Sahlgrenska University Hospital, Department of neurosurgeryMagnus Tisell, MD, PhD, Study director, Sahlgrenska Universtiy Hospital, Department of neurosurgeryPetter Förander, MD, PhD, Principal investigator, Karolinska University Hospital, Department of neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757235
- Sponsor's protocol ID
- SIC01
- Acronym
- SIC!
- Status last verified
- Feb 2022
- First submitted
- 28 Apr 2016
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Bartley A, Bartek J Jr, Jakola AS, Sundblom J, Falt M, Forander P, Marklund N, Tisell M. Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma: A Randomized Clinical Trial. JAMA Neurol. 2023 Jan 1;80(1):58-63. doi: 10.1001/jamaneurol.2022.4133.
PubMed 36409480Bartley 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.
PubMed 29021000
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma - A Multicenter Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02757235
- Acronym / sponsor ID
- SIC! / SIC01
- Conditions
- Chronic Subdural Hematoma
- Keywords
- chronic subdural hematoma, irrigation, recurrence, burr hole evacuation, temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Uppsala University Hospital
- Study start
- Mar 2016
- Primary completion
- Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrigation fluid of body temperature | Active comparator | Procedure: Irrigation fluid of body temperatureDuring burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of body temperature (approximately 37 degrees Celsius) |
| Irrigation fluid of room temperature | Active comparator | Procedure: Irrigation fluid of room temperatureDuring burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of room temperature (approximately 22 degrees Celsius) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic subdural hematoma requiring burr hole evacuation.
- Patients older than 18 years of age.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigation fluid of body temperatureIrrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma | Procedure or surgery | Irrigation fluid of body temperature |
| Irrigation fluid of room temperatureIrrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma. | Procedure or surgery | Irrigation fluid of room temperature |
Primary outcome
Recurrence rate
Time frame: 6 months
Recurrences requiring repeat surgery during a 6-month follow up period
3 secondary outcomes
Mortality
Time frame: 6 months
Complications related to the surgery
Time frame: 6 months
Health related quality of life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Derived from this study: PubMed 36409480Bartley A, Bartek J Jr, Jakola AS, Sundblom J, Falt M, Forander P, Marklund N, Tisell M. Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma: A Randomized Clinical Trial. JAMA Neurol. 2023 Jan 1;80(1):58-63. doi: 10.1001/jamaneurol.2022.4133.
- Derived from this study: PubMed 29021000Bartley 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asgeir Jakola, MD, PhD principal investigator
Sahlgrenska University Hospital, Department of neurosurgery
Niklas Marklund, MD, Phd principal investigator
Akademiska University Hospital, Department of neurosurgery
Jimmy Sundblom, MD, Phd principal investigator
Akademiska University Hospital, Department of neurosurgery
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation fluid of body temperature and Irrigation fluid of room temperature in people with Chronic Subdural Hematoma, run by Sahlgrenska University Hospital at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02757235, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.