The Effect of Subdural Drain Placement After Burr Hole Evacuation of Chronic Subdural Haematomas on Recurrence: a Prospective Randomised-controlled Multi-centre Study
试验速览
- 阶段
- 3 期
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Significant recurrent chronic subdural hematoma i.e. requiring repeat operative drainage at six months after the primary operation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •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.
- •Known epilepsy
- •Any neurological or non-neurological condition independent from SAH that might influence the functional outcome or other efficacy outcome measures
研究组 & 干预措施
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.
Intervention: silicon subdural drain
Placement of a silicon subdural drain after burr hole drainage of a chronic subdural hematoma.
干预措施: Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma (Device)
结局指标
主要结局
Significant recurrent chronic subdural hematoma i.e. requiring repeat operative drainage at six months after the primary operation
时间窗: Six months after primary burr hole evacuation of chronic subdural hematoma
次要结局
- 1. Functional performance in terms of the Extended Glasgow Outcome Scale(Upon discharge, 4 weeks and 6 months after primary operation)
- Added neurological deficit(Upon discharge, at 4 weeks and 6 months after primary operation)
- Surgery-related complications(Upon discharge, at 4 weeks and 6 months after primary operation)
- Death(Upon discharge, at 4 weeks and 6 months after primary operation)
- Modified Rankin Score(Upon discharge, at 4 weeks and 6 months)
研究者
Peter Woo Yat Ming
Associate Consultant
Kwong Wah Hospital