Tranexamic Acid to Prevent Operation in Chronic Subdural Hematoma

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 140

Inclusion Criteria

• 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

Exclusion Criteria

• 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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of TXA to prevent surgery for cSDH;Secondary Objective: To evaluate the efficacy of TXA to improve functional outcome (mRS), neurological impairment (mNIHSS), performance in activities of daily living (Barthel and Lawton-Brody), cognitive functioning (MOCA) and quality of life (SF-36 and EQ-5D). In addition, to evaluate the efficacy of TXA to reduce cSDH volume, mortality rate and health care costs. ;Primary end point(s): 1. Number of patients requiring surgery for cSDH within 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures