Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT03582293
Eligibility Criteria:
Inclusion Criteria:
* 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).
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 as described in paragraph 11.2), including language barrier;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03582293
Study Brief:
Protocol Section:
NCT03582293