Paracetamol (Acetaminophen) in Stroke 2 (PAIS 2): A randomized clinical trial to investigate the effect of high-dose paracetamol in patients with acute stroke and a body temperature of 36,5°C or above.
Recruiting
- Conditions
- acute stroke, cerebral infarction, intracraniel hemorrhage, acetaminophen, body temperature, inflammation, functional outcomeherseninfarct, hersenbloeding, paracetamol, lichaamstemperatuur, inflammatie, functionele uitkomst
- Registration Number
- NL-OMON24724
- Lead Sponsor
- Erasmus MC
- Brief Summary
Den Hertog HM et al. The Paracetamol (Acetaminophen) In Stroke trial: a multicentre, randomised, placebo-controlled, phase III trial. Lancet Neurol. 2009 May;8(5):434-40.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1500
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);
Exclusion Criteria
1. A body temperature lower than 36.5°C;
2. A history of liver disease or alcohol abuse;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A favorable outcome defined as improvement on the modified Rankin Scale (mRS) at 3 months from stroke onset.
- Secondary Outcome Measures
Name Time Method 1. Poor outcome defined as mRS>2 at 3 months;<br /><br>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;<br /><br>3. Body temperature 12-36 hours after start of treatment;<br /><br>4. Inflammatory markers and genetic variation thereof.