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
Background: Elderly patients are at high risk of complications after stroke, such as infections and fever. The occurrence of these complications has been associated with an increased risk of death or dependency. Hypothesis: Prevention of aspiration, infections, or fever with metoclopramide, ceftria...
| Main Authors: | , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Published: |
Sage
2018
|
| Subjects: | |
| Online Access: | https://eprints.nottingham.ac.uk/51630/ |
| _version_ | 1848798536871706624 |
|---|---|
| author | Reinink, Hendrik de Jonge, Jeroen C. Bath, Philip M. van de Beek, Diederik Berge, Eivind Borregaard, Saskia Ciccone, Alfonso Csiba, Laszlo Demotes, Jacques Dippel, Diederik W. Korv, Janika Kurkowska-Jastrzebska, Iwona Lees, Kennedy R Macleod, Malcolm R. Ntaios, George Randall, Gary Thomalla, Gotz van der Worp, Bart |
| author_facet | Reinink, Hendrik de Jonge, Jeroen C. Bath, Philip M. van de Beek, Diederik Berge, Eivind Borregaard, Saskia Ciccone, Alfonso Csiba, Laszlo Demotes, Jacques Dippel, Diederik W. Korv, Janika Kurkowska-Jastrzebska, Iwona Lees, Kennedy R Macleod, Malcolm R. Ntaios, George Randall, Gary Thomalla, Gotz van der Worp, Bart |
| author_sort | Reinink, Hendrik |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Background: Elderly patients are at high risk of complications after stroke, such as infections and fever. The occurrence of these complications has been associated with an increased risk of death or dependency.
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.
Design: International, 3 × 2-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 ≥ 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.
Outcome: The primary outcome measure is the score on the modified Rankin Scale at 90 days (± 14 days), as analysed with multiple regression.
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.
Planning: First patient included in May 2016; final follow-up of the last patient by April 2020 |
| first_indexed | 2025-11-14T20:21:20Z |
| format | Article |
| id | nottingham-51630 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:21:20Z |
| publishDate | 2018 |
| publisher | Sage |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-516302020-05-04T19:34:44Z https://eprints.nottingham.ac.uk/51630/ 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 Reinink, Hendrik de Jonge, Jeroen C. Bath, Philip M. van de Beek, Diederik Berge, Eivind Borregaard, Saskia Ciccone, Alfonso Csiba, Laszlo Demotes, Jacques Dippel, Diederik W. Korv, Janika Kurkowska-Jastrzebska, Iwona Lees, Kennedy R Macleod, Malcolm R. Ntaios, George Randall, Gary Thomalla, Gotz van der Worp, Bart Background: Elderly patients are at high risk of complications after stroke, such as infections and fever. The occurrence of these complications has been associated with an increased risk of death or dependency. 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. Design: International, 3 × 2-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 ≥ 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. Outcome: The primary outcome measure is the score on the modified Rankin Scale at 90 days (± 14 days), as analysed with multiple regression. 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. Planning: First patient included in May 2016; final follow-up of the last patient by April 2020 Sage 2018-04-30 Article PeerReviewed Reinink, Hendrik, de Jonge, Jeroen C., Bath, Philip M., van de Beek, Diederik, Berge, Eivind, Borregaard, Saskia, Ciccone, Alfonso, Csiba, Laszlo, Demotes, Jacques, Dippel, Diederik W., Korv, Janika, Kurkowska-Jastrzebska, Iwona, Lees, Kennedy R, Macleod, Malcolm R., Ntaios, George, Randall, Gary, Thomalla, Gotz and van der Worp, Bart (2018) 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. European Stroke Journal . ISSN 2396-9873 Stroke complications elderly ceftriaxone metoclopramide paracetamol http://journals.sagepub.com/doi/abs/10.1177/2396987318772687 doi:10.1186/ISRCTN82217627 doi:10.1186/ISRCTN82217627 |
| spellingShingle | Stroke complications elderly ceftriaxone metoclopramide paracetamol Reinink, Hendrik de Jonge, Jeroen C. Bath, Philip M. van de Beek, Diederik Berge, Eivind Borregaard, Saskia Ciccone, Alfonso Csiba, Laszlo Demotes, Jacques Dippel, Diederik W. Korv, Janika Kurkowska-Jastrzebska, Iwona Lees, Kennedy R Macleod, Malcolm R. Ntaios, George Randall, Gary Thomalla, Gotz van der Worp, Bart 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 |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Stroke complications elderly ceftriaxone metoclopramide paracetamol |
| url | https://eprints.nottingham.ac.uk/51630/ https://eprints.nottingham.ac.uk/51630/ https://eprints.nottingham.ac.uk/51630/ |