Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN 74418480]
The Paracetamol (Acetaminophen) In Stroke (PAIS) study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo.
The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever.The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS) may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis.
Methods: Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial.
Conclusions: The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power.Trial RegistrationCurrent Controlled Trials [ISCRTN74418480]
Author: Heleen M den Hertog, H BART van der Worp, H MAARTEN A van Gemert, Ale Algra, L JAAP van Kapelle, Jan van Gijn, Peter J Koudstaal, Diederik WJ Dippel and On behalf of the PAIS investigators.
Credits/Source: BMC Cardiovascular Disorders 2008, 8:2
Published on: 2008-11-04
Copyright by the authors listed above - made available via BioMedCentral (Open Access). Please
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