Tranexamic Acid to Prevent Operation in Chronic Subdural Hematoma - TORCH

Academic Medical Center0 个研究点目标入组 140 人开始时间: 2018年3月29日最近更新: 2024年7月29日

适应症

试验速览

暂无简介。

•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).
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•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);
•History of anaemia (haemoglobin <6mmol/L);
•History of convulsions;
•History of inability to safely swallow oral medication.
•Inability to obtain informed consent from the patient or legal representative (when the patient has a depressed level of consciousness), including language barrier;

发起方

Academic Medical Center