Efficacy and Safety of Dexamethasone in Management of Chronic Subdural Hematoma: A Single Center Randomized Control Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Failure rates
研究概览
简要总结
Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH is believed to arise from tearing of bridging veins as a result of trauma, which may be minor and unapparent to the patient. Management of cSDH is widely varied. A "wait-and-see" or "wait-and-rescan" approach may be acceptable in asymptomatic patients with a relatively small hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and recurrence rates of 4%-33% requiring further treatment in some instances.The safety and efficacy of different neurosurgical procedures have been evaluated but there is a paucity of well-designed randomized controlled trials in the literature. Consequently, there is no consensus on the best treatment with respect to surgical technique, pre-operative and post-operative management and nonsurgical alternatives including the use of Corticosteroids, Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE) inhibitors.
Corticosteroids may be a therapeutic option in the management of cSDH. There is very little data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized trials. The purpose of the study is to prove dexamethasone can be just as efficacious as surgery in treating chronic subdural hematoma. The investigators also hope to show that those patients treated with dexamethasone suffer less complication compared to those who undergo surgery.
详细描述
Chronic subdural hematoma (cSDH) is a collection of blood and its breakdown products in the subdural compartment. It is a condition frequently seen in any neurosurgical practice. cSDH is believed to arise from tearing of bridging veins as a result of trauma, which may be minor and unapparent to the patient. The one-year incidence rate is 1 to 8.2 per 100 000 in those 65 years or older. Advanced age is one of several risk factors and the incidence is expected to increase due to improved life expectancy. Other risk factors include brain atrophy, chronic alcoholism, intracranial hypotension, male gender and coagulopathy (including antiplatelet and antithrombotic therapy).
Management of cSDH is widely varied. A "wait-and-see" or "wait-and-rescan" approach may be acceptable in asymptomatic patients with a relatively small hematoma whilst cSDH with severe neurological deficits or decreased level of consciousness may require surgical decompression by burr-hole craniostomy, twist drill craniostomy or craniotomy. Surgery is associated with serious morbidity and mortality of up to 17% and recurrence rates of 4%-33% requiring further treatment in some instances.The safety and efficacy of different neurosurgical procedures have been evaluated but there is a paucity of well-designed randomized controlled trials in the literature. Consequently, there is no consensus on the best treatment with respect to surgical technique, pre-operative and post-operative management and nonsurgical alternatives including the use of Corticosteroids, Tranexamic acid, Osmotic diuretics, Atorvastatin or Angiotensin converting enzyme (ACE) inhibitors.
Corticosteroids may be a therapeutic option in the management of cSDH. There is very little data on the efficacy of corticosteroids in the treatment of cSDH and certainly no randomized trials. The purpose of the study is to prove dexamethasone can be just as efficacious as surgery in treating chronic subdural hematoma. The investigators also hope to show that those patients treated with dexamethasone suffer less complication compared to those who undergo 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 18 yrs
- •subacute/chronic subdural hematoma on CT or MRI performed within 72 hours prior to recruitment
- •patient must be symptomatic
排除标准
- •Glasgow Coma Scale (GCS) ≤ 12
- •patients needing craniotomy at the discretion of the on call neurosurgeon
- •hemiparesis with less than antigravity (≤ 3/5 medical research council scale) strength in any testable myotomes
- •°≥ 2 seizures at presentation or history of epilepsy
- •subdural hematoma with an underlying lesion or condition such as tumor, arachnoid cyst, presence of a ventriculoperitoneal shunt or vascular malformation
- •contraindication to dexamethasone including allergy or hypersensitivity to dexamethasone, immunocompromised/immunosuppressed patients, uncontrolled diabetes, untreated known peptic ulcer disease
- •pregnant/breastfeeding mothers
- •acute infection including latent/active tuberculosis (TB)
- •history of psychosis
- •anticoagulated for mechanical heart valve or arterial stent (i.e. coronary, carotid, or peripheral) placement
- •small volume, non-operable subdural collection
研究组 & 干预措施
Surgery
Patients in this arm will receive any form if surgical intervention (i.e. bedside burrhole craniostomy, 2 burrhole washout, craniotomy, endoscopy etc.) for treatment of their chronic subdural hematoma
干预措施: Any surgical intervention aim at treating chronic subdural hematoma (Procedure)
Dexamethasone
Patients in this arm will receive Dexamethasone over a 21day period for treatment of their chronic subdural hematoma
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Failure rates
时间窗: 3 months
Failure is defined as the requirement for surgical intervention in the dexamethasone group or re-operation in the surgical group.
次要结局
- Markwalder score(1, 3 and 6 months after treatment)
- Recurrence rate(3 months)
- Barthel index(1, 3 and 6 months after treatment)
- Glasgow Outcome Scale(1, 3 and 6 months after treatment)
- Quality of Life measured using the EQ-5D-5L(1, 3 and 6 months after treatment)
- Modified Ranking Scale(1, 3 and 6 months after treatment)
- Glasgow Coma Scale(1, 3 and 6 months after treatment)
- Clinical improvement (Categorized as resolved, improved, unchanged or worse)(1, 3 and 6 months after treatment)
- Radiologic outcomes (Change in hematoma volume)(1, 3 and 6 months after treatment)
- Mortality(1, 3 and 6 months)