CompletedPhase IIIInterventional

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

When an older person has a stroke, they have a higher risk of developing complications such as infections, fever, and nausea. These complications can slow down recovery, worsen brain damage, or lead to long-term disability. Doctors usually treat these issues only after they appear. This trial, called PRECIOUS, tests whether giving three well-known medicines straight away can prevent these problems from happening in the first place. The medicines tested are paracetamol (for fever), an antibiotic called ceftriaxone (for infections), and metoclopramide (for sickness). Adults aged 66 and older who have had a stroke within the last 12 hours can take part. Half receive the study drugs for up to four days alongside their usual stroke care, while others receive standard care alone. Researchers check in after three months to see how well patients have recovered.

At a glance

Status

Completed

Phase

Phase III

Sponsor

University Medical Center Utrecht

Enrolment target

3,800

Start

01 Feb 2016

Estimated completion

30 Jun 2022

Acute ischaemic stroke or intracerebral haemorrhage

What is this study about?

A stroke happens when blood flow to part of the brain is cut off by a clot, or when a blood vessel bursts and bleeds into the brain. Both types of stroke starve brain cells of oxygen, leading to sudden problems with movement, speech, or thinking. In older adults, the first few days following a stroke are critical for recovery.

After a stroke, many patients develop common complications such as chest or urine infections, fever, and vomiting. These problems put extra stress on a recovering brain. When complications arise, they significantly raise the risk of severe disability or death. In standard practice, doctors wait until symptoms like a high temperature or an infection show up before starting treatment.

The PRECIOUS study is investigating whether preventing these problems from the start works better. By giving preventative medicines immediately, researchers hope to protect the brain during its most vulnerable stage. If successful, this simple approach could improve survival, reduce long-term disability, and help more stroke survivors return to their normal lives.

Key takeaways

Tests whether giving common medicines early prevents complications after a stroke.
Aims to reduce disability and improve survival in older adults.
Open to adults aged 66 and older within 12 hours of stroke onset.
Uses trusted medicines: paracetamol, an antibiotic, and an anti-sickness drug.
Treatment lasts for up to four days in hospital, followed by a check-in at three months.

Who may be eligible?

This study is open to adults aged 66 and older who have had a moderate or severe stroke confirmed by a brain scan. Because early treatment is critical, the study medicine must be able to start within 12 hours of stroke symptoms first appearing.

People cannot take part if they already had severe disability requiring round-the-clock nursing care before the stroke, or if they are sadly nearing the end of life. Patients who already have an active infection needing antibiotics when they arrive at the hospital are also excluded.

Doctors will carefully check each person's medical history to ensure the medicines are safe for them. For instance, people with known allergies to these drugs, severe liver problems, Parkinson's disease, epilepsy, or serious bowel blockages will not be given the specific medicines that could harm them.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you (or the person you care for) aged 66 or older?
Did stroke symptoms start within the last 12 hours?
Has a brain scan confirmed an acute stroke?
Were you largely independent in daily tasks before the stroke occurred?
Are you free from an existing infection requiring antibiotics right now?

Answer every question to see your result.

What does participation involve?

Taking part begins while the patient is admitted to hospital for their stroke. Participants are placed into a treatment group by chance, similar to a coin toss. Depending on the group, patients receive either standard stroke care alone or standard care plus one or more preventative medicines: paracetamol, an antibiotic, or anti-sickness treatment. These medicines are given for four days or until the person is discharged from hospital, whichever comes first. There are no extra hospital visits required during this stay. Three months later, a researcher will contact the participant or their family—usually by telephone—to check on their recovery, daily activities, memory, and general quality of life.

Potential risks and benefits

Taking part may reduce the chance of developing dangerous complications after a stroke, which could improve recovery, but these benefits cannot be guaranteed. The drugs used—paracetamol, ceftriaxone, and metoclopramide—are very well known and have been used safely in hospitals for decades. The most common side effects are mild, such as tummy upset or loose stools, and serious allergic reactions are rare. Patients are monitored closely by hospital doctors throughout. Participation is entirely voluntary, and patients or their families can withdraw at any time without it affecting the quality of standard NHS care.

Locations (9)

Royal Infirmary of Edinburgh
Approximate
Edinburgh, Scotland
Tartu University Hospital
Approximate
Tartu, Estonia
University Medical Center Hamburg-Eppendorf
City only
Hamburg, Germany
Larissa University Hospital
Approximate
Larissa, Greece
University of Debrecen
Approximate
Debrecen, Hungary
Carlo Poma Hospital
Unverified
Mantova, Mantua, Italy
University Medical Center Utrecht
Unverified
Utrecht, Netherlands
Oslo University Hospital
Unverified
Oslo, Norway
Institute of Psychiatry and Neurology
Unverified
Warsaw, Poland

Common questions

Why are these specific medicines being tested?

Paracetamol, ceftriaxone, and metoclopramide are already trusted treatments for fever, infections, and sickness. Researchers want to find out if giving them early stops complications before they can cause harm.

Will taking part replace standard stroke care?

No. All patients receive full standard stroke care. The study treatments are given on top of normal hospital treatment.

How is it decided which group a patient enters?

A computer chooses at random. This process ensures that the study remains fair and gives scientifically reliable answers.

What happens if a patient cannot speak or give consent?

Because strokes often affect speech and alertness, a family member, partner, or legal representative can give permission for the patient to join if appropriate.

Do participants need to return to the hospital for extra visits?

No. The main treatment takes place while already in hospital, and the three-month follow-up check is usually carried out over the phone.

How to find out more

Bart van der Worp

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.