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

Conditions

Acute ischaemic stroke or intracerebral haemorrhage Circulatory System 1. Acute ischaemic stroke 2. Intracerebral haemorrhage

de Jonge JC, Sluis WM, Reinink H, Bath PM, Woodhouse LJ, Zweedijk B, van de Beek D, Aamodt AH, Alpers I, Ciccone A, Csiba L, Demotes J, Kõrv J, Kurkowska-Jastrzebska I, Dawson J, Macleod MR, Ntaios G, Poli S, Milionis H, Ricci S, Cenciarelli S, Candelaresi P, de Bruijn SF, Pathansali R, Krishnan K, Clarke B, Thomalla G, van der Worp HB, PRECIOUS investigators.

2023-12-018 citations

10.1016/j.lanepe.2023.100782

PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke—statistical analysis plan of a randomised, open, phase III, clinical trial with blinded outcome assessment

Jeroen C. de Jonge, Lisa J Woodhouse, Hendrik Reinink, H. Bart van der Worp, Philip M. Bath et al. (6 authors)

Trials2020-10-266 citations

10.1186/s13063-020-04717-0

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

Hendrik Reinink, Jeroen C. de Jonge, Philip M. Bath, Diederik van de Beek, Eivind Berge et al. (18 authors)

European Stroke Journal2018-04-3025 citations

10.1177/2396987318772687

Interventions

Patients will be randomly allocated in a 2*2*2 factorial design to any combination of open-label oral or rectal metoclopramide (10 mg thrice daily), intravenous ceftriaxone (2000 mg once daily), oral,

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
At 7 days (± 1 day) or at discharge, if earlier: 1. Infections in the first 7 days (± 1 day; frequency, type, and C. difficile infections). Infections will be categorised as diagnosed by the clinician, and as judged by an independent adjudication committee (masked to treatment allocation); 2. Third generation cephalosporin resistance in the first 7 days (± 1 day), detected as part of routine clinical practice; 3. Antimicrobial use during the first 7 days (± 1 day), converted to units of defined daily doses according to the classification of the WHO Anatomical Therapeutic Chemical Classification System with Defined Daily Doses Index; 4. In a subgroup of patients: presence of Extended-Spectrum Beta-Lactamase (ESBL)-producing bacteria as detected by PCR in a rectal swab. At 91 days (± 14 days): 1. Death; 2. Unfavourable functional outcome, defined as mRS 3 to 6; 3. Disability assessed with the score on the Barthel Index (BI); 4. Cognition assessed with the Montreal Cognitive Assessment (MoCA); 5. Quality of life assessed with the EuroQol 5D-5L (EQ-5D-5L); 6. Home time: duration of stay in the patient’s own home or a relative’s home over the first 90 days; 7. Patient location over first 91 days (± 14 days): hospital; rehabilitation service; chronic nursing facility; home; 8. SAEs in the first 14 days.	—

Measure

Time frame

At 7 days (± 1 day) or at discharge, if earlier: 1. Infections in the first 7 days (± 1 day; frequency, type, and C. difficile infections). Infections will be categorised as diagnosed by the clinician, and as judged by an independent adjudication committee (masked to treatment allocation); 2. Third generation cephalosporin resistance in the first 7 days (± 1 day), detected as part of routine clinical practice; 3. Antimicrobial use during the first 7 days (± 1 day), converted to units of defined daily doses according to the classification of the WHO Anatomical Therapeutic Chemical Classification System with Defined Daily Doses Index; 4. In a subgroup of patients: presence of Extended-Spectrum Beta-Lactamase (ESBL)-producing bacteria as detected by PCR in a rectal swab. At 91 days (± 14 days): 1. Death; 2. Unfavourable functional outcome, defined as mRS 3 to 6; 3. Disability assessed with the score on the Barthel Index (BI); 4. Cognition assessed with the Montreal Cognitive Assessment (MoCA); 5. Quality of life assessed with the EuroQol 5D-5L (EQ-5D-5L); 6. Home time: duration of stay in the patient’s own home or a relative’s home over the first 90 days; 7. Patient location over first 91 days (± 14 days): hospital; rehabilitation service; chronic nursing facility; home; 8. SAEs in the first 14 days.

—

Countries

Estonia, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Scotland, United Kingdom

Contacts

Public ContactBart van der Worp

Outcome results

None listed