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The Effect of Subdural Drain Placement After Burr Hole Evacuation of Chronic Subdural Haematomas on Recurrence: a Prospective Randomised-controlled Multi-centre Study

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ClinicalTrials.gov Identifier: NCT01785797
Recruitment Status : Unknown
Verified February 2013 by Peter Woo Yat Ming, Kwong Wah Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Peter Woo Yat Ming, Kwong Wah Hospital

Tracking Information
First Submitted Date  ICMJE February 5, 2013
First Posted Date  ICMJE February 7, 2013
Last Update Posted Date February 7, 2013
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Subdural Drain Placement After Burr Hole Evacuation of Chronic Subdural Haematomas on Recurrence: a Prospective Randomised-controlled Multi-centre Study
Official Title  ICMJE The Effect of Subdural Drain Placement After Burr Hole Evacuation of Chronic Subdural Haematomas on Recurrence: a Prospective Randomised-controlled Multi-centre Study
Brief 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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Subdural Hematoma
  • Subdural Drain
Intervention  ICMJE Device: Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma
Study Arms  ICMJE
  • No Intervention: Control: burr hole drainage only
    Burr hole drainage of chronic subdural hematoma under general or local anesthesia without the subsequent placement of a subdural drain.
  • Experimental: Intervention: silicon subdural drain
    Placement of a silicon subdural drain after burr hole drainage of a chronic subdural hematoma.
    Intervention: Device: Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 6, 2013)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients diagnosed to have symptomatic chronic subdural haematoma confirmed by a computed tomography or magnetic resonance imaging brain scan.
  2. Ethnic Chinese
  3. Age >/= 60 years-old
  4. Reasonable expectation of completion of outcome measures at follow-up
  5. Written informed consent

Exclusion Criteria:

  1. Unsalvageable patients: fixed and dilated pupils after resuscitation or signs of brainstem herniation that precludes definitive therapy.
  2. 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.
  3. History of previous cranial neurosurgical procedure.
  4. On concurrent glucocorticoid therapy.
  5. Suspected intracranial hypotension syndrome.
  6. Blood dyscrasia:

    1. 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).
    2. Thrombocytopenia: platelet level <100 x 109/l
    3. Coagulopathy: prothrombin time PT >12sec or, activated partial thromboplastin time (APTT) >37.4 sec
  7. End-stage renal/ hepatic failure.
  8. Known or strong suspicion of alcohol or illicit drug abuse.
  9. Pregnancy
  10. Known epilepsy
  11. Any neurological or non-neurological condition independent from SAH that might influence the functional outcome or other efficacy outcome measures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01785797
Other Study ID Numbers  ICMJE Subdural Drain Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Woo Yat Ming, Kwong Wah Hospital
Study Sponsor  ICMJE Kwong Wah Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kwong Wah Hospital
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP