Hematoma, Subdural, ChronicNCT01930617
Irrigation of Chronic Subdural Hematomas - is More Better?
An observational study of Hematoma, Subdural, Chronic, run by St. Olavs Hospital at 3 sites in 2 countries.
Trial summary
There are numerous reported ways to treat chronic subdural hematomas (CSDH) and practice is still differing considerably between departments. Except for a recent randomized controlled trial (RCT) that found that postoperative subdural drainage was better than no drain, there is no higher level evidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematoma, Subdural, Chronic
- What is being tested?
- Burr hole surgery with various drainage techniques
- Type of treatment
- Surgery or procedure
- How many people
- 1,258 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2014to Dec 2016
- Phase
- Observational
- 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
Study population: The patients have been selected to the given therapy solely on the basis of geography. All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at St.Olav University Hospital and UNN, and primary CSDH from 2006 through 2010 at Karolinska University Hospital (not 2005 due to practical reasons since major changes occurred in electronic surgery protocols 2005).
Who may be able to join
- All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at St.Olav University Hospital
- All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at University Hospital North Norway
- All patients treated with evacuation of primary CSDH from 2006 through 2010 at Karolinska University Hospital (not 2005 due to practical reasons since major changes occurred in electronic surgery protocols 2005).
Who cannot join
- Chronic subdural hematoma in arachnoid cyst(s)
- Previous CSDH surgery
- External hydrocephalus (hydrocephalus with cerebrospinal fluid (CSF) in the subdural space rather than in the ventricles)
- CSDH due to previous intracranial surgery (within 6 months).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Norway2 sites
University Hospital of North Norway
Tromsø
St Olavs Hospital
Trondheim
About this study
Official title: Irrigation of Chronic Subdural Hematomas - is More Better? A Population Based Study Between Different Treatment Policies
There are numerous reported ways to treat chronic subdural hematomas (CSDH) and practice is still differing considerably between departments. Except for a recent randomized controlled trial (RCT) that found that postoperative subdural drainage was better than no drain, there is no higher level evidence. Another recent RCT did not replicate these findings, but the study was severely underpowered.
Aim of this population based study is to compare clinical results (reoperation rates, complications, perioperative death, and survival) between neurosurgical departments treating CSDH with different treatment policies.
- Conditions
- Hematoma, Subdural, Chronic
- Being tested
- Burr hole surgery with various drainage techniques
- Keywords
- surgery, trephining, drainage, therapeutic irrigation, subdural space, postoperative complications, mortality
- Medical subject headings
- Hematoma, Subdural, Chronic, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burr hole surgery with various drainage techniquesProcedure or surgery
Surgical technique
- Continuous irrigation and drainage
- Passive subdural drain
- Active subgaleal drain
| Study group | Role | What they receive |
|---|---|---|
| Trondheim | Burr hole surgery with passive subdural drainage Receives: Procedure: Burr hole surgery with various drainage techniques | |
| Tromsø | Burr hole surgery with continuous irrigation Receives: Procedure: Burr hole surgery with various drainage techniques | |
| Stockholm | Burr hole surgery with active subgaleal drainage Receives: Procedure: Burr hole surgery with various drainage techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
reoperations
Number of reoperations (X/N, %) between centers
Measured: 1 year
Secondary outcomes (4)
continuous irrigation versus other drainage
Number of reoperations with use of continuous irrigation (UNN) versus other drainage (St.Olav, Karolinska)
Measured: 1 year
perioperative death
Measured: 30 days
survival
Minimum 3 years follow up. Report 1 year mortality and use of Kaplan Meier curves (log rank test)
Measured: 3 years
surgical complications
As defined by the Ibanez classification where it is the treatment given for a complication that gives the score. Medical and surgical complication is both mentioned and reported seperately
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematoma, Subdural, ChronicStudies of the same condition, open and under way.
- More trials run by St. Olavs 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University Hospital of North Norway, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Lars Jacob Stovner, MD PhD, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930617
- Sponsor's protocol ID
- 2011/2050
- Status last verified
- Jun 2017
- First submitted
- 22 Aug 2013
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sjavik K, Bartek J, Sagberg LM, Henriksen ML, Gulati S, Stahl FL, Kristiansson H, Solheim O, Forander P, Jakola AS. Assessment of drainage techniques for evacuation of chronic subdural hematoma: a consecutive population-based comparative cohort study. J Neurosurg. 2017 Jun 23;133(4):1113-1119. doi: 10.3171/2016.12.JNS161713.
PubMed 28644099
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irrigation of Chronic Subdural Hematomas - is More Better? A Population Based Study Between Different Treatment Policies
- ClinicalTrials.gov ID
- NCT01930617
- Acronym / sponsor ID
- 2011/2050
- Conditions
- Hematoma, Subdural, Chronic
- Keywords
- surgery, trephining, drainage, therapeutic irrigation, subdural space, postoperative complications, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,258 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University Hospital of North Norway, Karolinska Institutet
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Aug 2013 (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.
There are numerous reported ways to treat chronic subdural hematomas (CSDH) and practice is still differing considerably between departments. Except for a recent randomized controlled trial (RCT) that found that postoperative subdural drainage was better than no drain, there is no higher level evidence. Another recent RCT did not replicate these findings, but the study was severely underpowered.
Aim of this population based study is to compare clinical results (reoperation rates, complications, perioperative death, and survival) between neurosurgical departments treating CSDH with different treatment policies.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trondheim | – | Procedure: Burr hole surgery with various drainage techniquesBurr hole surgery with passive subdural drainage |
| Tromsø | – | Procedure: Burr hole surgery with various drainage techniquesBurr hole surgery with continuous irrigation |
| Stockholm | – | Procedure: Burr hole surgery with various drainage techniquesBurr hole surgery with active subgaleal drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients have been selected to the given therapy solely on the basis of geography. All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at St.Olav University Hospital and UNN, and primary CSDH from 2006 through 2010 at Karolinska University Hospital (not 2005 due to practical reasons since major changes occurred in electronic surgery protocols 2005).
Key inclusion criteria (3 listed)
- All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at St.Olav University Hospital
- All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at University Hospital North Norway
- All patients treated with evacuation of primary CSDH from 2006 through 2010 at Karolinska University Hospital (not 2005 due to practical reasons since major changes occurred in electronic surgery protocols 2005).
Key exclusion criteria (4 listed)
- Chronic subdural hematoma in arachnoid cyst(s)
- Previous CSDH surgery
- External hydrocephalus (hydrocephalus with cerebrospinal fluid (CSF) in the subdural space rather than in the ventricles)
- CSDH due to previous intracranial surgery (within 6 months).
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 |
|---|---|---|
| Burr hole surgery with various drainage techniquesSurgical technique 1. Continuous irrigation and drainage 2. Passive subdural drain 3. Active subgaleal drain | Procedure or surgery | Stockholm, Tromsø, Trondheim |
Primary outcome
reoperations
Time frame: 1 year
Number of reoperations (X/N, %) between centers
4 secondary outcomes
continuous irrigation versus other drainage
Time frame: 1 year
perioperative death
Time frame: 30 days
survival
Time frame: 3 years
surgical complications
Time frame: 30 days
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 27 Jun 2017.
- Results publication: PubMed 28644099Sjavik K, Bartek J, Sagberg LM, Henriksen ML, Gulati S, Stahl FL, Kristiansson H, Solheim O, Forander P, Jakola AS. Assessment of drainage techniques for evacuation of chronic subdural hematoma: a consecutive population-based comparative cohort study. J Neurosurg. 2017 Jun 23;133(4):1113-1119. doi: 10.3171/2016.12.JNS161713.
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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.
Lars Jacob Stovner, MD PhD study chair
St. Olavs Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematoma, Subdural, Chronic, run by St. Olavs Hospital at 3 sites in 2 countries.
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 3 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 27 Jun 2017. 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 Norway, 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?
reoperations (time frame: 1 year). 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 NCT01930617, which also lists 1 linked publication.
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 27 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.