Skip to content

Paracetamol (Acetaminophen) In Stroke.

A multi-center, randomized, double blind, placebo-controlled clinical trial on the effect of paracetamol on functional outcome in acute stroke.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25645
Enrollment
2500
Registered
2006-08-07
Start date
2003-05-01
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

stroke

Interventions

Treatment with high dose paracetamol (6 g/day) or placebo will start within 12 hours after onset of symptoms, and continue for 3 days.

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of acute stroke 2. Possibility to start treatment within 12 hours from onset 3. Brain CT or MRI within 24 hours 4. Age 18 years or older 5. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. A body temperature lower than 36 degrees Celsius or higher than 39 degrees Celsius 2. A history of liver disease 3. Alcohol abuse 4. Liver enzymes increased above twice the upper limit of normal 5. Allergy to paracetamol 6. Significant pre-stroke impairment (³3 on the modified Rankin Scale (mRS))

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the dichotomized mRS (¡Ü2: good outcome, ¡Ý3: poor outcome) at 3 months.

Secondary

MeasureTime frame
Secondary endpoints are the score on the Barthel index after two weeks, body temperature after 24 hours of treatment, and the EuroQol-5D at 3 months.

Contacts

Public ContactH. Hertog, den

Erasmus Medical Center Department of Neurology, Suite Ee 2240 P.O. Box 2040

m.denhertog@erasmusmc.nl+31(0)10 4639222

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)