acute stroke, cerebral infarction, intracraniel hemorrhage, acetaminophen, body temperature, inflammation, functional outcome herseninfarct, hersenbloeding, paracetamol, lichaamstemperatuur, inflammatie, functionele uitkomst
Conditions
Interventions
Paracetamol or matching placebo will be administered 6 times daily for three consecutive days
the first 24 hours as suppositories of 1 g, or as 2 tablets of 500 mg per dosage (after swallowing difficulties have been excluded), from 24-72 hours as 2 tablets of 500 mg per dosage.
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of ischemic stroke or intracerebral hemorrhage, confirmed by CT or MRI scan within 24 hours after inclusion in the study; 2. A measurable deficit on the National Institutes of Health Stroke Scale (NIHSS); 3. The possibility to start treatment within 12 hours of symptom onset (for patients who noticed symptoms when awaking from sleep, the time last seen well is taken as the time of onset of symptoms); 4. A body temperature of 36,5°C or higher; 5. Age of 18 years or older; 6. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. A body temperature lower than 36.5°C; 2. A history of liver disease or alcohol abuse; 3. Liver enzymes (ASAT, ALAT, AP or gamma-GT) increased above twice the upper limit of normal values; 4. Allergy to paracetamol; 5. Death appearing imminent at the time of inclusion; 6. Any pre-stroke impairment that has led to dependency (modified Rankin scale (mRS)>2) and therefore interferes with the assessment of functional outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A favorable outcome defined as improvement on the modified Rankin Scale (mRS) at 3 months from stroke onset. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Poor outcome defined as mRS>2 at 3 months; 2. Barthel index score as an indicator of functional status (ranging from 0-20, 20 indicating no disability and 0 indicating complete dependence) and European Quality of Life-5 dimensions (EQ5D)25 score at 3 months; 3. Body temperature 12-36 hours after start of treatment; 4. Inflammatory markers and genetic variation thereof. | — |
Contacts
Public ContactInger Ridder, de
Dr. Molewaterplein 50-60
Outcome results
None listed