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The occurrence of these complications has been associated with an increased risk of death or dependency.<\/jats:p>\n                    <jats:p>Hypothesis: Prevention of aspiration, infections, or fever with metoclopramide, ceftriaxone, paracetamol, or any combination of these in the first four days after stroke onset will improve functional outcome at 90 days in elderly patients with acute stroke.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>International, 3\u2009\u00d7\u20092-factorial, randomised-controlled, open-label clinical trial with blinded outcome assessment (PROBE) in 3800 patients aged 66 years or older with acute ischaemic stroke or intracerebral haemorrhage and an NIHSS score \u2265 6. Patients will be randomly allocated to any combination of oral, rectal, or intravenous metoclopramide (10 mg thrice daily); intravenous ceftriaxone (2000 mg once daily); oral, rectal, or intravenous paracetamol (1000 mg four times daily); or usual care, started within 24 h after symptom onset and continued for four days or until complete recovery or discharge from hospital, if earlier.<\/jats:p>\n                    <jats:p>Outcome: The primary outcome measure is the score on the modified Rankin Scale at 90 days (\u00b1 14 days), as analysed with multiple regression.<\/jats:p>\n                    <jats:p>Summary: This trial will provide evidence for a simple, safe and generally available treatment strategy that may reduce the burden of death or disability in patients with stroke at very low costs.<\/jats:p>\n                    <jats:p>Planning: First patient included in May 2016; final follow-up of the last patient by April 2020.<\/jats:p>\n                    <jats:p>Registration: ISRCTN, ISRCTN82217627, https:\/\/doi.org\/10.1186\/ISRCTN82217627<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2396987318772687","type":"journal-article","created":{"date-parts":[[2018,4,30]],"date-time":"2018-04-30T09:18:13Z","timestamp":1525079893000},"page":"291-298","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":21,"title":["PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke. Rationale and design of a randomised, open, phase III, clinical trial with blinded outcome assessment"],"prefix":"10.1093","volume":"3","author":[{"given":"Hendrik","family":"Reinink","sequence":"first","affiliation":[{"name":"Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus Institute, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands 1"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeroen C","family":"de Jonge","sequence":"additional","affiliation":[{"name":"Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus Institute, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands 1"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip M","family":"Bath","sequence":"additional","affiliation":[{"name":"Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK 2"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diederik","family":"van de Beek","sequence":"additional","affiliation":[{"name":"Department of Neurology, Academic Medical Center, Amsterdam Neuroscience, Amsterdam, The Netherlands 3"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eivind","family":"Berge","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Oslo University Hospital, Oslo, Norway 4"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saskia","family":"Borregaard","sequence":"additional","affiliation":[{"name":"Clinical Trial Center North GmbH, Hamburg, Germany 5"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfonso","family":"Ciccone","sequence":"additional","affiliation":[{"name":"Department of Neurology and Stroke Unit, ASST di Mantova, Mantua, Italy 6"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laszlo","family":"Csiba","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Debrecen, Debrecen, Hungary 7"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacques","family":"Demotes","sequence":"additional","affiliation":[{"name":"European Clinical Research Infrastructure Network (ECRIN), Paris, France 8"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diederik W","family":"Dippel","sequence":"additional","affiliation":[{"name":"Department of Neurology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands 9"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janika","family":"K\u00f5rv","sequence":"additional","affiliation":[{"name":"Department of Neurology and Neurosurgery, University of Tartu, Tartu, Estonia 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