Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480]

doi:10.1186/1471-2261-8-29

BMC Cardiovascular Disorders

Volume 8

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Algra A
Kappelle LJ
van Gijn J
Koudstaal PJ
Dippel DW

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Correction

Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480]

Heleen M den Hertog¹^* , H Bart van der Worp²^* , H Maarten A van Gemert³^* , Ale Algra²^,4^* , L Jaap Kappelle²^* , Jan van Gijn²^* , Peter J Koudstaal¹^* and Diederik WJ Dippel¹ for the PAIS investigators

¹Department of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands

²Department of Neurology, Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht. Utrecht, the Netherlands

³Department of Neurology, Meander Medical Center Amersfoort, the Netherlands

⁴Department of Neurology and Julius Center, University Medical Center Utrecht, and department of Clin Epidemiology, Leiden University Medical Center, the Netherlands

author email corresponding author email* Contributed equally

BMC Cardiovascular Disorders 2008, 8:29doi:10.1186/1471-2261-8-29


Published:	4 November 2008

Abstract

Background

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.

Conclusion

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 Registration

Current Controlled Trials [ISCRTN74418480]