PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke
Every year, 1.3 million Europeans have a stroke. 20 to 35% of the patients die in the first month after stroke, and around one third remain dependent on the help of others. The annual costs for stroke care in Europe are estimated at € 64.1 billion. Mainly in the first days after stroke onset, patients are at risk of complications, such as infections and fever. These complications are strongly and independently associated with a higher risk of death or dependency.
PRECIOUS is a pragmatic, randomised, open clinical trial with blinded outcome assessment in 3,800 patients with acute stroke aged 66 years or older. The trial will assess whether pharmacological prevention of infections and fever, and early management of dysphagia, will reduce the risk of death, poor functional outcome, and poor quality of life, and lead to reductions in the costs of stroke care throughout Europe. Patients will be randomised using a factorial design to preventive treatment with ceftriaxone, paracetamol, and/or metoclopramide, or to ‘standard care’ alone. This simple, safe, and generally available treatment strategy has the potential to lead to an annual reduction of over 25,000 elderly Europeans being dead or dependent as a result of stroke, at very low costs.
The project is coordinated by Dr Van der Worp (UMC Utrecht) and started on 1 June 2015. A total of 6 million Euros has been awarded to the consortium to run the trial over 7 years. PRECIOUS has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634809.
The source of this text and more information on Precious research is the project’s web site https://www.precious-trial.eu/ .
INVOLVING STROKE SURVIVORS IN CLINICAL TRIALS
Interview with a PRECIOUS clinical trial patient, Utrecht
SAFE: Why did you think it was important to take part in the PRECIOUS clinical trial?
PATIENT: For us (me and my family) the stroke diagnosis and treatment was a nerve-racking experience, however we think research is important, and this trial did sound like a potential beneficial treatment.
SAFE: Did you have any fears or reservations before making the decision?
PATIENT: Not really no, the trial was clearly explained by the physician, and we recognised the importance of it, so we wanted to take part.
SAFE: Do you think participation has benefited you? (eg did it make you feel more positive about the future, more confident, happier?)
PATIENT: At the moment, I am doing really well. I have been improving steadily the last three months. I hope off course, part of this is due to my participating in this trial, because that would mean the treatment could work.
SAFE: What are your hopes after taking part?
PATIENT: I hope it provides valuable information for the researchers, to improve care for patients with stroke. I have recovered quite well, but I know from other stories this is not always the case.
SAFE: What would you say to someone who is considering participating in a trial?
PATIENT: Do consider it! Research and clinical trials are usually well thought-out, and it could potentially be beneficial for you or future patients
SAFE: If you were asked to take part in a trial now, would the pandemic influence your decision
PATIENT: Off course, at this moment everything is influenced by the pandemic. It would off course depend on the type of trial, but yes I would still participate in a trial.