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

Medical Centre Haaglanden (MCH)0 个研究点目标入组 170 人开始时间: 2016年2月15日最近更新: 2021年3月8日

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•- Presence of a chronic subdural hematoma: An isodens or hypodens hematoma on cranial CT-scan. Hyperdens components may be present but must compromise less than 1/3 of the hematoma.
•- Clinical symptoms must correlate to the cerebral lesion.
•- Severity of symptoms must be Marwalder Grading Score 1-3.
•- Subject must be 18 years or older.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 85
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 85

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•- An acute subdural haematoma.
•- Pregnancy.
•- Known hypersensitivity to DXM.
•- Known ulceration in the gastro-intestinal tract.
•- Uncontrolled diabetes mellitus (DM).
•- 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).

发起方

Medical Centre Haaglanden (MCH)