No registrations found.
ID
Source
Brief title
Health condition
acute stroke, cerebral infarction, intracraniel hemorrhage, acetaminophen, body temperature, inflammation, functional outcome
herseninfarct, hersenbloeding, paracetamol, lichaamstemperatuur, inflammatie, functionele uitkomst
Sponsors and support
Intervention
Outcome measures
Primary outcome
A favorable outcome defined as improvement on the modified Rankin Scale (mRS) at 3 months from stroke onset.
Secondary outcome
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.
Background summary
In the Paracetamol (Acetaminophen) in Stroke (PAIS) trial, a double-blind, placebo-controlled randomized clinical trial of 1400 patients with acute stroke, the paracetamol-treated patients (6 g daily, 3 days) showed more improvement on the modified Rankin scale (mRS) at 3 months, yet the difference was not statistically significant. In the 661 patients with a baseline body temperature of 36,5°C or above, treatment with paracetamol led to a larger decrease in temperature (0.30°C; 95% CI: 0.20-0.40), increased the odds of improvement (OR 1.43; 95% CI: 1.02-1.97) and was associated with a 7% (95% CI: 0-15%, p=0.06) absolute decrease in the risk of poor outcome. These findings need further study.
Study objective
We hypothesize that treatment of patients with acute ischemic or hemorrhagic stroke and a body temperature of 36,5°C or above with paracetamol in a daily dose of 6 g for three consecutive days, leads to improved functional outcome.
At least 50% of patients with acute stroke have a body temperature over 36,5°C. Increased body temperature is related to poor functional outcome. The risk of poor outcome may double with each degree Celsius increase in body temperature.
Study design
1. Oktober 2010: first inclusion;
2. Juli 2014: final inclusion;
3. Oktober 2014: end of follow-up.
Intervention
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.
Inger Ridder, de
Rotterdam 3015 GE
The Netherlands
+31 (0)10 7040704
i.deridder@erasmusmc.nl
Inger Ridder, de
Rotterdam 3015 GE
The Netherlands
+31 (0)10 7040704
i.deridder@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2239 |
| NTR-old | NTR2365 |
| Other | WHO UTN : U1111-1124-9185 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |