Tranexamic Acid to Prevent Operation in Chronic Subdural Hematoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29498

Enrollment

140

Registered

2017-10-14

Start date

2017-03-28

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic subdural hematoma, chronisch subduraal hematoom, tranexamic acid, tranexaminezuur, burr-hole drainage, boorgatdrainage

Interventions

Oral tranexamic acid 500mg two times a day for a total of 28 days

Eligibility

Inclusion criteria

Inclusion criteria: · Age 50 years and above; · On CT and/or MRI confirmed cSDH (isodense or hypodense subdural collection, uni- or bilateral); · 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

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); · Anaemia (haemoglobin <6g/dl); · History of convulsions; · Pregnancy (checked with a pregnancy test only in women in their childbearing period) or breastfeeding; · Inability to obtain informed consent from the patient or legal representative (including language barrier);

Design outcomes

Secondary

Measure	Time frame
1. Functional outcome at four, eight and 12 weeks, measured with the modified Rankin Scale (mRS) score; 2. Neurological impairment at four, eight and 12 weeks, measured with the modified National Institutes of Health Stroke Scale (mNIHSS) score; 3. Quality of life at four and eight weeks, measured with the Short Form Health Survey (SF-36) questionnaire; 4. Performance in activities of daily living at four, eight and 12 weeks, measured with the Barthel Index scale and the Lawton-Brody scale; 5. Cognitive functioning at four, eight and 12 weeks, measured with the Montreal Cognitive Assessment (MOCA) test; 6. Quality of life at 12 weeks, measured with the five dimensional EuroQol (EQ-5D) questionnaire; 7. Volume and percentage of volume reduction of cSDH at four, eight and 12 weeks on follow-up CT scan of the head; 8. Mortality at four, eight and 12 weeks; 9. Health care costs at four, eight and 12 weeks. 10. Occurrence of thromboembolic complications at two, four, eight and 12 weeks (definitie);	—

Measure

Time frame

1. Functional outcome at four, eight and 12 weeks, measured with the modified Rankin Scale (mRS) score; 2. Neurological impairment at four, eight and 12 weeks, measured with the modified National Institutes of Health Stroke Scale (mNIHSS) score; 3. Quality of life at four and eight weeks, measured with the Short Form Health Survey (SF-36) questionnaire; 4. Performance in activities of daily living at four, eight and 12 weeks, measured with the Barthel Index scale and the Lawton-Brody scale; 5. Cognitive functioning at four, eight and 12 weeks, measured with the Montreal Cognitive Assessment (MOCA) test; 6. Quality of life at 12 weeks, measured with the five dimensional EuroQol (EQ-5D) questionnaire; 7. Volume and percentage of volume reduction of cSDH at four, eight and 12 weeks on follow-up CT scan of the head; 8. Mortality at four, eight and 12 weeks; 9. Health care costs at four, eight and 12 weeks. 10. Occurrence of thromboembolic complications at two, four, eight and 12 weeks (definitie);

—

Primary

Measure	Time frame
1. Number of patients requiring surgery for cSDH within 12 weeks; 2. Quality of life at 12 weeks, measured with the Short Form Health Survey (SF-36) questionnaire.	—

Contacts

Public ContactS. Immenga

Academic Medical Center, dept. Neurosurgery

s.immenga@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)