Prevention of complications to Improve outcome in elderly patients with acute stroke - A randomised clinical trial

Phase 3

Completed

• Conditions: Acute ischaemic stroke or intracerebral haemorrhage; Circulatory System; 1. Acute ischaemic stroke2. Intracerebral haemorrhage

• Registration Number: ISRCTN82217627
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30246150 protocol 2022 Abstract results in https://doi.org/10.1177/23969873221094907 (added 10/10/2023) 2017 Abstract results in https://doi.org/10.1177/2396987317706897 (added 10/10/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38074444/ (added 11/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-22
• Study Completion: 2022-09-30
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1493

Inclusion Criteria

1. Clinical diagnosis of acute ischaemic stroke or intracerebral haemorrhage (confirmed with CT or MRI scan)
2. Score on the National Institutes of Health Stroke Scale58 (NIHSS) =6, indicating moderately severe to severe stroke
3. Aged 66 years or older
4. Possibility to start trial treatment within 12 h of symptom onset

Exclusion Criteria

All participants:
1. Active infection requiring antibiotic treatment, as judged by the treating physician;
2. Pre-stroke score on the modified Rankin Scale =4
3. Death appearing imminent at the time of assessment.

For the ceftriaxone arm:
1. Known hypersensitivity to beta-lactam antibiotics

For the paracetamol arm:
1. Known hypersensitivity to paracetamol or any of the excipients
2. Known severe hepatic insufficiency
3. Chronic alcoholism

For the metoclopramide arm:
1. Hypersensitivity to the metoclopramide or to any of the excipients
2. Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk
3. Confirmed or suspected pheochromocytoma
4. History of neuroleptic or metoclopramide-induced tardive dyskinesia
5. Epilepsy
6. Parkinson's disease
7. Use of levodopa or dopaminergic agonists
8. Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Handicap as assessed with the score on the modified Rankin Scale at 91 days (± 14), and analysed with ordinal logistic regression.