NL-OMON55350招募中3 期
Dexamethasone (DXM) therapy in symptomatic patients with chronic subdural hematoma (DECSA- Trial). Effect of initial corticosteroid therapy versus primary surgery on clinical outcome. - DECSA-trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- Presence of a newly diagnosed CSDH: An isodens or hypodens haematoma on
- •cranial CT-scan. Hyperdens components may be present but must compromise less
- •than 1/3 of the haematoma.
- •- Clinical symptoms must correlate to the cerebral lesion.
- •- Patient would be an eligible candidate for BHC, based on the clinical
- •condition and radiologic appearance of CSDH.
- •- Severity of symptoms must be MGS 1-3.
- •- Subject must be 18 years or older.
- •- Written informed consent.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- MGS 0 or MGS 4.
- •- An acute subdural haematoma.
- •- Presence of a minimal CSDH on cranial CT, which is technically not drainable
- •by BHC (i.e. haematoma thickness < 10 mm).
- •- Pregnancy.
- •- Cerebrospinal fluid shunt in situ.
- •- Known hypersensitivity to DXM.
- •- Known ulceration in the gastro-intestinal tract.
- •- Uncontrolled diabetes mellitus (DM), defined as a HbA1C value > 8% (64
- •- Clinical suspicion of an acute systemic infection (fever, leucocytosis,
- •elevated C-reactive protein (CRP)).
- •- History of gastro-intestinal bleeding.
- •- Glaucoma.
- •- Previous history of severe affective disorders on steroids (i.e. psychosis).
- •, Additional exclusion criteria concerning participation of the MRI-substudy:
- •- Subjects with a contra-indication to an MRI examination.
- •- Subjects who have a documented allergy to MRI contrast media or a
- •contra-indication for contrast-media.
- •- Claustrophobia.
- •- Having any physical or mental complaints (i.e. delirious condition with motor
- •disturbance) that interferes with a (safe) MRI-procedure
研究者
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