Chronic Subdural HematomaNCT01869855
A Prospective Randomized Study Evaluating the Recurrence Rate of Chronic Subdural Hematoma After Placing a Subperiosteal Drainage Compared to a Subdural Drainage
A study testing Subdural Drainage and Subperiosteal Drainage in people with Chronic Subdural Hematoma, run by Kantonsspital Aarau at 2 sites in Switzerland.
Trial summary
The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage. 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?
- Subdural Drainage and Subperiosteal Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2013to Jan 2017
- 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
- Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma
- Chronic subdural hematoma verified on cranial CT or MRI
Who cannot join
- The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy)
- Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt)
- no informed consent
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Neurosurgery Kantonsspital Aarau
Aarau, Canton of Aargau, 5000
Neurosurgery University Hospital of Basel
Basel, 4038
About this study
Official title: Use of Subperiosteal Drainage Versus Subdural Drainage in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: a Randomized Controlled Trial
The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage.
We hypothesize that patients treated with a subperiosteal drainage do not show higher recurrence rates than those treated with a subdural drainage, and suffer less complications.
Read the detailed description
Chronic subdural haematoma (cSDH) is one of the most frequent neurosurgical entities, affecting elderly people and associated with substantial morbidity and mortality. Its incidence is reported to be 1.7-13.1 per 100000 inhabitants per year, yet there has been a steady increasing incidence as the result of prolonged life expectancy in recent years. Surgical treatment is recommended in case of neurological symptoms. In the only evidence based review of the different surgical treatment modalities of cSDH, Weigels study group concluded that bure-hole craniostomy with irrigation and drainage has the best cure to complication ratio. A randomized controlled study of Santarius and his colleagues showed a reduced recurrence and mortality while placing a subdural drainage compared to no drainage after burr hole evacuation of cSDH. Gazzeri et al. and Zumofen et al. used closed subperiosteal drainage instead of the commonly used subdural drainage. They showed equal or superior results in outcome, complications and postoperative symptoms compared to previous studies. Since the subperiosteal drainage is not positioned in direct contact to cortical structures, bridging veins or haematoma membranes it is considered safer and should be favored over a subdural drainage. Bellut et al. compared in their institute retrospectively 48 patients treated with subperiosteal drainage to 65 patients with subdural drainage and found no difference in recurrence rate of cSDH, yet less mortality and fewer serious complications in the group treated with subperiosteal drainage. However in their study none of the results showed a significant difference, and they concluded that further randomized studies with larger patient number are needed. In a recently published prospective randomized study Kaliaperumal et al. concluded that the recurrence rate in subperiosteal drainage is equal to subdural drainage, yet the modified ranking scale(mRS) of the patients with subperiosteal drainage after 6 months was significantly better. However, the mRS score preoperative were better in the subperiosteal drain group causing a statistical bias. In addition the amount patients studied was small (25 per group) and the recurrence rate was overall at 0%, with a very low morbidity and mortality compared to the literature. Due to these bias the authors recommend further prospective and randomized studies with larger group of patients.
To date in neurosurgery practice evidence based guidelines on which drainage should be used in cSDH do not exist and both methods, subdural drainage and subperiosteal drainage, are being practiced, depending on the institute and/or the practicing neurosurgeon.
The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Subdural Drainage, Subperiosteal Drainage
- Keywords
- chronic subdural hematoma, traumatic brain injury, burr hole trepanation, drainage after evacuation of chronic subdural hematoma, intracranial bleed
- Medical subject headings
- Hematoma, Subdural, Chronic, Brain Injuries, Traumatic, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subdural DrainageProcedure or surgery
Subperiosteal DrainageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 110 patients with cSDH assigned to subdural drainage | Active comparator | Randomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study. Receives: Procedure: Subdural Drainage |
| 110 patients with cSDH assigned to subperiosteal drainage | Active comparator | Randomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study. Receives: Procedure: Subperiosteal Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate
Measured: within the first 12 months postoiperatively
Secondary outcomes (5)
Complication rate (Morbidity)
Measured: within the first 12 months postoperatively
Mortality
Measured: within the first 12 months postoperatively
Outcome: Markwalder Score
Measured: within the first 12 months postoperatively
Outcome: modified Ranking Score
Measured: within the first 12 months postoperatively
Outcome: Glasgow Outcome Score
Measured: within the first 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2017
- Study completionJan 2017
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 Chronic Subdural HematomaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jehuda Soleman, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869855
- Sponsor's protocol ID
- CSDH-KSA
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2013
- Last updated
- 27 Jun 2017
- Results posted
- No
Publications
Soleman J, Lutz K, Schaedelin S, Mariani L, Fandino J. Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Apr 8;5(2):e38. doi: 10.2196/resprot.5339.
PubMed 27059872
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
- Use of Subperiosteal Drainage Versus Subdural Drainage in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01869855
- Acronym / sponsor ID
- CSDH-KSA
- Conditions
- Chronic Subdural Hematoma
- Keywords
- chronic subdural hematoma, traumatic brain injury, burr hole trepanation, drainage after evacuation of chronic subdural hematoma, intracranial bleed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Jun 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.
The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage.
We hypothesize that patients treated with a subperiosteal drainage do not show higher recurrence rates than those treated with a subdural drainage, and suffer less complications.
Detailed description
Chronic subdural haematoma (cSDH) is one of the most frequent neurosurgical entities, affecting elderly people and associated with substantial morbidity and mortality. Its incidence is reported to be 1.7-13.1 per 100000 inhabitants per year, yet there has been a steady increasing incidence as the result of prolonged life expectancy in recent years. Surgical treatment is recommended in case of neurological symptoms. In the only evidence based review of the different surgical treatment modalities of cSDH, Weigels study group concluded that bure-hole craniostomy with irrigation and drainage has the best cure to complication ratio. A randomized controlled study of Santarius and his colleagues showed a reduced recurrence and mortality while placing a subdural drainage compared to no drainage after burr hole evacuation of cSDH. Gazzeri et al. and Zumofen et al. used closed subperiosteal drainage instead of the commonly used subdural drainage. They showed equal or superior results in outcome, complications and postoperative symptoms compared to previous studies. Since the subperiosteal drainage is not positioned in direct contact to cortical structures, bridging veins or haematoma membranes it is considered safer and should be favored over a subdural drainage. Bellut et al. compared in their institute retrospectively 48 patients treated with subperiosteal drainage to 65 patients with subdural drainage and found no difference in recurrence rate of cSDH, yet less mortality and fewer serious complications in the group treated with subperiosteal drainage. However in their study none of the results showed a significant difference, and they concluded that further randomized studies with larger patient number are needed. In a recently published prospective randomized study Kaliaperumal et al. concluded that the recurrence rate in subperiosteal drainage is equal to subdural drainage, yet the modified ranking scale(mRS) of the patients with subperiosteal drainage after 6 months was significantly better. However, the mRS score preoperative were better in the subperiosteal drain group causing a statistical bias. In addition the amount patients studied was small (25 per group) and the recurrence rate was overall at 0%, with a very low morbidity and mortality compared to the literature. Due to these bias the authors recommend further prospective and randomized studies with larger group of patients.
To date in neurosurgery practice evidence based guidelines on which drainage should be used in cSDH do not exist and both methods, subdural drainage and subperiosteal drainage, are being practiced, depending on the institute and/or the practicing neurosurgeon.
The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 110 patients with cSDH assigned to subdural drainage | Active comparator | Procedure: Subdural DrainageRandomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study. |
| 110 patients with cSDH assigned to subperiosteal drainage | Active comparator | Procedure: Subperiosteal DrainageRandomization of 110 patients with cSDH to one treatment group (subdural or subperiosteal drainage) out of the 220 patients included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma
- Chronic subdural hematoma verified on cranial CT or MRI
Key exclusion criteria (3 listed)
- The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy)
- Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt)
- no informed consent
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 |
|---|---|---|
| Subdural Drainage | Procedure or surgery | 110 patients with cSDH assigned to subdural drainage |
| Subperiosteal Drainage | Procedure or surgery | 110 patients with cSDH assigned to subperiosteal drainage |
Primary outcome
Recurrence Rate
Time frame: within the first 12 months postoiperatively
5 secondary outcomes
Complication rate (Morbidity)
Time frame: within the first 12 months postoperatively
Mortality
Time frame: within the first 12 months postoperatively
Outcome: Markwalder Score
Time frame: within the first 12 months postoperatively
Outcome: modified Ranking Score
Time frame: within the first 12 months postoperatively
Outcome: Glasgow Outcome Score
Time frame: within the first 12 months postoperatively
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.
- Derived from this study: PubMed 27059872Soleman J, Lutz K, Schaedelin S, Mariani L, Fandino J. Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Apr 8;5(2):e38. doi: 10.2196/resprot.5339.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subdural Drainage and Subperiosteal Drainage in people with Chronic Subdural Hematoma, run by Kantonsspital Aarau at 2 sites in Switzerland.
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 3 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 2 sites in Switzerland. 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: within the first 12 months postoiperatively). 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 NCT01869855, 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 27 Oct 2026.