The influence on functional outcome of treatment with high dose acetaminophen in patients with acute stroke and a body temperature of 36.5 degrees Celsius or higher

• Conditions: acute stroke (cerebral infarction or intracrebral hemorrhage) and a body temperature of 36.5 degrees or above.; MedDRA version: 14.1Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-021437-30-NL
• Lead Sponsor: ErasmusMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-01
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- clinical diagnosis of ischemic stroke or intracerebral hemorrhage, confirmed by CT or MRI scan within 24 hours after inclusion in the study
- a measurable deficit on the National Institutes of Health Stroke Scale (NIHSS)
- 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)
- a body temperature of 36.5°C or higher
- age of 18 years or older
- signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

- a body temperature lower then 37.0°C
- a history of liver disease or alcohol abuse
- liver enzymes (ASAT, ALAT, AP or gamma-GT) increased above twice the upper limit of normal values
- allergy to paracetamol
- death appearing imminent at the time of inclusion
- any pre-stroke impairment that has led to dependency (modified Rankin scale (mRS)>2) and therefore interferes with the assessment of functional outcome.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of early treatment with paracetamol in a daily dose of 6 g for three consecutive days in patients with acute stroke and a body temperature of 36.5°C or above on the occurrence of a favorable functional outcome.<br><br>;Secondary Objective: 1. To investigate the association between body temperature in the first 12-36 hours after acute stroke and serum inflammation markers. <br>2. To investigate the relationship between paracetamol in a daily dose of 6 g for three days and an inflammatory response in stroke. ;Primary end point(s): The primary outcome will be improvement beyond expectation on the mRS at 3 months.;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary outcomes will be poor outcome defined as mRS>2 at 3 months; score on the Barthel index and EQ5D score at 3 months; and body temperature 24 hours after start of treatment.;Timepoint(s) of evaluation of this end point: 3 months