Chronic Subdural HematomaPhase 3NCT01785797
The Effect of Subdural Drain Placement After Burr Hole Evacuation of Chronic Subdural Haematomas on Recurrence: a Prospective Randomised-controlled Multi-centre Study
A Phase 3 study testing Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma in people with Chronic Subdural Hematoma and Subdural Drain, run by Kwong Wah Hospital at 1 site in China.
Trial summary
This is a prospective randomised-controlled multi-centre trial based in Hong Kong to determine whether temporary subdural drain placement after burr hole evacuation of a chronic subdural haematoma can reduce the risk of recurrence. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Subdural Drain
- What is being tested?
- Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2015
- Phase
- Phase 3
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed to have symptomatic chronic subdural haematoma confirmed by a computed tomography or magnetic resonance imaging brain scan.
- Ethnic Chinese
- Age >/= 60 years-old
- Reasonable expectation of completion of outcome measures at follow-up
- Written informed consent
Who cannot join
- Unsalvageable patients: fixed and dilated pupils after resuscitation or signs of brainstem herniation that precludes definitive therapy.
- When the operating surgeon judges that drain placement may be hazardous or to be of limited benefit e.g. readily expanded brain in young patients.
- History of previous cranial neurosurgical procedure.
- On concurrent glucocorticoid therapy.
- Suspected intracranial hypotension syndrome.
- Blood dyscrasia:
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- Use of antiplatelet medication e.g. aspirin or warfarin without adequate reversal or observation for drug effect to wear off (at least 5-7 days).
- Thrombocytopenia: platelet level <100 x 109/l
- Coagulopathy: prothrombin time PT >12sec or, activated partial thromboplastin time (APTT) >37.4 sec
- End-stage renal/ hepatic failure.
- Known or strong suspicion of alcohol or illicit drug abuse.
- Pregnancy
- Known epilepsy
- Any neurological or non-neurological condition independent from SAH that might influence the functional outcome or other efficacy outcome measures
Trial locations and contacts
1 site in 1 country.
China1 site
Prince of Wales Hospital
Hong Kong, Hong Kong
Peter YM Woo, FRCS (SN), 852+ 3517 2275 ext. 2275, peterymwoo@gmail.com
About this study
This is a prospective randomised-controlled multi-centre trial based in Hong Kong to determine whether temporary subdural drain placement after burr hole evacuation of a chronic subdural haematoma can reduce the risk of recurrence. Consecutive patients, 60 years old or above, diagnosed to have symptomatic chronic subdural haematoma and indicated for burr hole operative drainage will be randomly allocated into one of two groups: (1) for intra-operative subdural drain placement (intervention group) or (2) not for drain placement (control group). Using web-based software block randomisation with an allocation ratio of 1:1 will be conducted. Instructions to use or not to use a drain will be contained in a sealed envelopes labelled with sequential study numbers.
Intra-operatively, if the surgeon-in-charge judges that after burr hole evacuation of the haematoma the patient's condition is unsafe for drain placement, the subject will be excluded from the study. Otherwise, randomisation will be performed at this juncture by the opening of the sealed envelop. The procedure involves placing a prefabricated silicon drain into the subdural space according to a standard protocol and will be removed on the second post-operative day at the bedside. Subjects in whom the operating surgeon judges that drain placement is unsafe will be excluded from the study. Drainage is undertaken passively by hanging the collection bag at the bedside in a dependent position. In addition to general demographic, clinical and radiological presentation data, potential risk factors for recurrence will be documented. Serial computed tomography brain scans will be arranged (before discharge, at four weeks and six months) and the occurence of significant subdural haematoma recurrence requiring repeat operative drainage at six months will be recorded. Other outcome measures to be determined at regular time intervals for a total follow-up period of six months (upon discharge, at four weeks and six months) include: functional performance in terms of the extended Glasgow Outcome Scale and modified Rankin Scale, added neurological deficit, death and other surgery-related complications. All outcomes will be documented by the trial investigators or by the responsible clinician. The data obtained will be analysed according to the principle of intention to treat.
Hypothesis: compared to burr-hole evacuation of chronic subdural haematoma alone (control), the additional placement of a subdural drain after evacuation (intervention) will reduce the risk of recurrence requiring repeat surgery.
- Conditions
- Chronic Subdural Hematoma, Subdural Drain
- Being tested
- Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicon subdural drain placement after burr hole evacuation of chronic subdural hematomaDevice
| Study group | Role | What they receive |
|---|---|---|
| Control: burr hole drainage only | No intervention | Burr hole drainage of chronic subdural hematoma under general or local anesthesia without the subsequent placement of a subdural drain. |
| Intervention: silicon subdural drain | Experimental | Placement of a silicon subdural drain after burr hole drainage of a chronic subdural hematoma. Receives: Device: Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant recurrent chronic subdural hematoma i.e. requiring repeat operative drainage at six months after the primary operation
Measured: Six months after primary burr hole evacuation of chronic subdural hematoma
Secondary outcomes (5)
1. Functional performance in terms of the Extended Glasgow Outcome Scale
Measured: Upon discharge, 4 weeks and 6 months after primary operation
Added neurological deficit
Measured: Upon discharge, at 4 weeks and 6 months after primary operation
Surgery-related complications
Measured: Upon discharge, at 4 weeks and 6 months after primary operation
Death
Measured: Upon discharge, at 4 weeks and 6 months after primary operation
Modified Rankin Score
Measured: Upon discharge, at 4 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kwong Wah Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Woo Yat Ming, Kwong Wah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785797
- Sponsor's protocol ID
- Subdural Drain Study
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subdural Drain Placement After Burr Hole Evacuation of Chronic Subdural Haematomas on Recurrence: a Prospective Randomised-controlled Multi-centre Study
- ClinicalTrials.gov ID
- NCT01785797
- Acronym / sponsor ID
- Subdural Drain Study
- Conditions
- Chronic Subdural Hematoma, Subdural Drain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Kwong Wah HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Feb 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.
This is a prospective randomised-controlled multi-centre trial based in Hong Kong to determine whether temporary subdural drain placement after burr hole evacuation of a chronic subdural haematoma can reduce the risk of recurrence. Consecutive patients, 60 years old or above, diagnosed to have symptomatic chronic subdural haematoma and indicated for burr hole operative drainage will be randomly allocated into one of two groups: (1) for intra-operative subdural drain placement (intervention group) or (2) not for drain placement (control group). Using web-based software block randomisation with an allocation ratio of 1:1 will be conducted. Instructions to use or not to use a drain will be contained in a sealed envelopes labelled with sequential study numbers.
Intra-operatively, if the surgeon-in-charge judges that after burr hole evacuation of the haematoma the patient's condition is unsafe for drain placement, the subject will be excluded from the study. Otherwise, randomisation will be performed at this juncture by the opening of the sealed envelop. The procedure involves placing a prefabricated silicon drain into the subdural space according to a standard protocol and will be removed on the second post-operative day at the bedside. Subjects in whom the operating surgeon judges that drain placement is unsafe will be excluded from the study. Drainage is undertaken passively by hanging the collection bag at the bedside in a dependent position. In addition to general demographic, clinical and radiological presentation data, potential risk factors for recurrence will be documented. Serial computed tomography brain scans will be arranged (before discharge, at four weeks and six months) and the occurence of significant subdural haematoma recurrence requiring repeat operative drainage at six months will be recorded. Other outcome measures to be determined at regular time intervals for a total follow-up period of six months (upon discharge, at four weeks and six months) include: functional performance in terms of the extended Glasgow Outcome Scale and modified Rankin Scale, added neurological deficit, death and other surgery-related complications. All outcomes will be documented by the trial investigators or by the responsible clinician. The data obtained will be analysed according to the principle of intention to treat.
Hypothesis: compared to burr-hole evacuation of chronic subdural haematoma alone (control), the additional placement of a subdural drain after evacuation (intervention) will reduce the risk of recurrence requiring repeat surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: burr hole drainage only | No intervention | –Burr hole drainage of chronic subdural hematoma under general or local anesthesia without the subsequent placement of a subdural drain. |
| Intervention: silicon subdural drain | Experimental | Device: Silicon subdural drain placement after burr hole evacuation of chronic subdural hematomaPlacement of a silicon subdural drain after burr hole drainage of a chronic subdural hematoma. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed to have symptomatic chronic subdural haematoma confirmed by a computed tomography or magnetic resonance imaging brain scan.
- Ethnic Chinese
- Age >/= 60 years-old
- Reasonable expectation of completion of outcome measures at follow-up
- Written informed consent
Key exclusion criteria (14 listed)
- Unsalvageable patients: fixed and dilated pupils after resuscitation or signs of brainstem herniation that precludes definitive therapy.
- When the operating surgeon judges that drain placement may be hazardous or to be of limited benefit e.g. readily expanded brain in young patients.
- History of previous cranial neurosurgical procedure.
- On concurrent glucocorticoid therapy.
- Suspected intracranial hypotension syndrome.
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 |
|---|---|---|
| Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma | Device | Intervention: silicon subdural drain |
Primary outcome
Significant recurrent chronic subdural hematoma i.e. requiring repeat operative drainage at six months after the primary operation
Time frame: Six months after primary burr hole evacuation of chronic subdural hematoma
5 secondary outcomes
1. Functional performance in terms of the Extended Glasgow Outcome Scale
Time frame: Upon discharge, 4 weeks and 6 months after primary operation
Added neurological deficit
Time frame: Upon discharge, at 4 weeks and 6 months after primary operation
Surgery-related complications
Time frame: Upon discharge, at 4 weeks and 6 months after primary operation
Death
Time frame: Upon discharge, at 4 weeks and 6 months after primary operation
Modified Rankin Score
Time frame: Upon discharge, at 4 weeks and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma in people with Chronic Subdural Hematoma and Subdural Drain, run by Kwong Wah Hospital at 1 site in China.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter YM Woo, FRCS (SN) (852+ 3517 2275 ext. 2275, peterymwoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant recurrent chronic subdural hematoma i.e. requiring repeat operative drainage at six months after the primary operation (time frame: Six months after primary burr hole evacuation of chronic subdural hematoma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2013.