PRECIOUS inclusion
PRECIOUS inclusion
PRECIOUS inclusion

undefinedClick here to download the summary card

 

Inclusion procedure

 

2. Ask for Informed Consent

  • Remember resistance sub-study

 

3. Randomise via www.precious-trial.eu

  • Press on the yellow randomization button

  • Log in with your own "Username" and "Password"

  • Press "Add new subject" in left top corner

  • Select correct study ‘site’ and press ‘Save’

  • Fill in the inclusion form

  • Press "Randomise"

  • The randomisation result appears in the screen (NB: write the randomisation result in the electronic patient file)

  • Press “Close” on the randomisation screen

  • Press “Submit” at the bottom right corner of the inclusion form

 

4. If allocated to treatment, start treatment as soon as possible, but within 24 hours after symptom onset

 

Medications

prescribe use of medication of for 96 hours

• Ceftriaxone once daily 2000mg. Administration: intravenous.

• Paracetamol 4 times daily 1000mg. Administration: oral, rectal, or intravenous.

• Metoclopramide thrice daily 10mg. Administration: oral, rectal, or intravenous.

 

For metoclopramide, adjust the dosage to renal or hepatic function:

- End-stage renal disease (creatinine clearance ≤ 15 ml/min): 3 times 2.5mg daily

- Moderate to severe renal impairment (15-60 ml/min) or severe hepatic

impairment (liver cirrhosis): 3 times 5mg daily

 

Inclusion criteria

1. A clinical diagnosis of acute ischaemic stroke or intracerebral haemorrhage,

confirmed with CT or MRI scan. A normal CT scan is considered compatible with

ischaemic stroke;

2. A score on the National Institutes of Health Stroke Scale (NIHSS) ≥ 6, indicating

moderately severe to severe stroke;

3. Age 66 years or older;

4. The possibility to start treatment within 24 hours of symptom onset

5. Written informed consent.

Exclusion criteria

1. Active infection requiring antibiotic treatment, as judged by the

treating physician;

2. Pre-stroke score on the mRS ≥4

3. Death appearing imminent at the time of assessment.

 

 

For the ceftriaxone stratum:

1. Known hypersensitivity to beta-lactam antibiotics;

2. Clinical indication for antibiotic treatment. The use of an antibiotic before
screening is not an exclusion criterion.

For the paracetamol stratum:

1. Known hypersensitivity to paracetamol or any of the excipients

2. Known severe hepatic insufficiency;

3. Chronic alcoholism.

4. Clinical indication for the use of paracetamol. Incidental use of paracetamol
before screening is not an exclusion criterion.

For the metoclopramide stratum:

1.Hypersensitivity to 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.

9. Clinical indication for the use of metoclopramide. Incidental use of
metoclopramide before screening is not an exclusion criterion.

 

 

 

Coordinating Investigator Trial Coordinators

H.B. van der Worp

T +31 (0)88 75 511 82

J.C. de Jonge / H. Reinink

T +31 6 13 43 58 07 / +31 6 30 79 89 32

h.b.vanderworp(at)umcutrecht.nl h.reinink-2(at)umcutrecht.nl

precious(at)umcutrecht.nl j.c.dejonge-6(at)umcutrecht.nl


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