brain haemorrhage chronic haemorrhage in the subdural space
Conditions
Interventions
During four weeks, the intervention group will receive oral TXA twice daily
500mg, the control group receives a placebo twice daily. The TXA or placebo
treatment is additional to standard care.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Necessity for surgery after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional outcome (mRS), neurological impairment (mNIHSS), performance in activities of daily living (Barthel and Lawton-Brody), cognitive functioning (MOCA), quality of life (SF-36 and EQ-5D), cSDH volume, incidence of falling, mortality rate and health care costs. | — |
Countries
Netherlands
Outcome results
None listed