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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Switzerland

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.

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 groups in NCT01869855
Study groupRoleWhat they receive
110 patients with cSDH assigned to subdural drainageActive comparatorRandomization 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 drainageActive comparatorRandomization 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.

  1. Recurrence Rate

    Measured: within the first 12 months postoiperatively

Secondary outcomes (5)
  1. Complication rate (Morbidity)

    Measured: within the first 12 months postoperatively

  2. Mortality

    Measured: within the first 12 months postoperatively

  3. Outcome: Markwalder Score

    Measured: within the first 12 months postoperatively

  4. Outcome: modified Ranking Score

    Measured: within the first 12 months postoperatively

  5. 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.

  1. First posted5 Jun 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

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)
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

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.

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