Tranexamic Acid to Prevent Operation in Chronic Subdural Hematoma
- Conditions
- brain haemorrhagechronic haemorrhage in the subdural space100097201000796310047075
- Registration Number
- NL-OMON54811
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
• 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).
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method