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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Kwong Wah Hospital
Sponsor:
Information provided by (Responsible Party):
Peter Woo Yat Ming, Kwong Wah Hospital
ClinicalTrials.gov Identifier:
NCT01785797
First received: February 5, 2013
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Chronic Subdural Hematoma
Subdural Drain
Device: Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kwong Wah Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. Functional performance in terms of the Extended Glasgow Outcome Scale [ Time Frame: Upon discharge, 4 weeks and 6 months after primary operation ] [ Designated as safety issue: No ]
  • Added neurological deficit [ Time Frame: Upon discharge, at 4 weeks and 6 months after primary operation ] [ Designated as safety issue: Yes ]
  • Surgery-related complications [ Time Frame: Upon discharge, at 4 weeks and 6 months after primary operation ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: Upon discharge, at 4 weeks and 6 months after primary operation ] [ Designated as safety issue: Yes ]
  • Modified Rankin Score [ Time Frame: Upon discharge, at 4 weeks and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785797

Contacts
Contact: Peter YM Woo, FRCS (SN) 852+ 3517 2275 ext 2275 peterymwoo@gmail.com

Locations
China, Hong Kong
Prince of Wales Hospital Not yet recruiting
Hong Kong, Hong Kong, China, N.A.
Contact: Peter YM Woo, FRCS (SN)    852+ 3517 2275 ext 2275    peterymwoo@gmail.com   
Sponsors and Collaborators
Kwong Wah Hospital
  More Information

No publications provided

Responsible Party: Peter Woo Yat Ming, Associate Consultant, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT01785797     History of Changes
Other Study ID Numbers: Subdural Drain Study
Study First Received: February 5, 2013
Last Updated: February 6, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Hematoma
Hematoma, Subdural
Hematoma, Subdural, Chronic
Recurrence
Disease Attributes
Pathologic Processes
Hemorrhage
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Silicon
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014