NL-OMON54811招募中3 期
Tranexamic Acid to Prevent Operation in Chronic Subdural Hematoma - TORCH
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
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
- •Age 50 years and above;
- •On CT confirmed cSDH;
- •Primary conservative treatment, based on clinical symptoms: Glasgow Coma
- •Scale score >=14, mNIHSS score <=4 and a stable neurological deficit (no new,
- •or progression of, symptoms between the assessment by the neurologist and the
- •assessment by the neurosurgeon).
排除标准
- •Primary surgical treatment based on one or more of the following symptoms or
- •parameters: medically intractable headache, midline shift >10mm, imminent death
- •within 24 hours;
- •Structural causes for subdural haemorrhage, e.g. arachnoid cysts, cortical
- •vascular malformations and a history of cranial surgery <1year;
- •Aneurysmal subarachnoid haemorrhage;
- •Active treatment for deep vein thrombosis, pulmonary embolism or cerebral
- •thrombosis (secondary prophylaxis is not considered to be active treatment);
- •Active intravascular clotting or disseminated intravascular coagulation;
- •Known hypersensitivity or allergy to TXA or to any of the ingredients;
- •History of a blood coagulation disorder (hypercoagulability disorder);
- •History of severe impairment of renal function (eGFR <30ml/min or serum
- •creatinine >150µmol/L);
- •Amanesis with signs of anemia (fatigue, headache, exercise intolerance,
- •weakness and pallor (conjunctival) dry skin);
- •History of epilepsy;
- •History of inability to safely swallow oral medication;
- •Inability to obtain informed consent from the patient or legal
- •representative, including language barrier.
研究者
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