Chronic Subdural Hematoma MedDRA version: 20.1 Level: LLT Classification code 10049163 Term: Chronic subdural hematoma System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Cyclokapron
Pharmaceutical Form: Capsule
INN or Proposed INN: Cyclokapron
CAS Number: 1197-18-8
Other descriptive name: TRANEXAMIC ACID
Pharmaceutical form of the placebo: Capsule
Route of
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
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 =65 years) yes F.1.3.1 Number of subjects for this age range 100
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); • 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Volume and percentage of volume reduction of cSDH at four, eight and 12 weeks on follow-up CT scan of the head; 3. Neurological impairment at four, eight and 12 weeks, measured with the modified National Institutes of Health Stroke Scale (mNIHSS) score; 4. Number of falling incidents during the 12 week study period; 5. Cognitive functioning at four, eight and 12 weeks, measured with the Montreal Cognitive Assessment (MOCA) test; 6. Performance in activities of daily living at 12 weeks, measured with the a. Barthel Index scale and b. Lawton-Brody scale; 7. Functional outcome at 12 weeks, measured with the modified Rankin Scale (mRS) score; 8. Quality of life at 12 weeks, measured with the a. Short Form Health Survey (SF-36) questionnaire (main secondary outcome) and b. five dimensional EuroQol (EQ-5D-3L) questionnaire; 9. Mortality at 12 weeks; 10. Care and health-related costs during the 12 week study period, measured with the a. Medical Consumption Questionnaire (iMCQ) and b. the Productivity Cost Questionnaire (iPCQ). 11. Number of patients requiring surgery for cSDH within 6 monthts;Timepoint(s) of evaluation of this end point: 12 weeks and 6 months | — |
Countries
Netherlands
Contacts
Public ContactDept. Neurosurgery
Academic Medical Center
Outcome results
None listed