What is the purpose of the study?

Many stroke survivors are prone to medical complications in the first days after stroke. These complications include problems with swallowing, infections and fever and they may cause the survivor to have a poorer outcome in the long term. So, we would like to know if prevention of these complications can improve this long-term outcome after stroke. Treatment of these complications is possible with well-known, simple and safe medications: the anti-sickness drug metoclopramide, the antibiotic ceftriaxone, and paracetamol for fever. Our idea is to give patients some or all of these drugs to prevent problems with complications before they happen.

 

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How is the study funded and who are the investigators?

PRECIOUS is a not-for-profit clinical trial that is funded by the European Union. The purpose of the study is to test common drugs in a new way. We will not be testing new drugs. No pharmaceutical companies are involved in the trial. The study team consists of a large number of doctors, nurses and stroke research specialists from 11 European countries.

 

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How long will I have to take the preventative medication for?

The study medication will be given for four days. The trial assesses the effects of three different types of medication: metoclopramide, ceftriaxone and paracetamol. Both metoclopramide and paracetamol may be given in three ways: oral, rectal, or via a tube into your vein you already have for other purposes. The method of administration depends on your ability to swallow and on local hospital practice. Ceftriaxone can only be given via a tube into your vein. Metoclopramide will be given three times a day, ceftriaxone once a day and paracetamol four times a day.

 

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When will I have to decide whether to participate?

Because we are investigating preventive medication, it is important that the drugs are administered early after the stroke, so the complications we are trying to prevent have not already occurred. Therefore, patients can only be included if the first administration of the drugs is within 12 hours after stroke onset. This means that if you or your relative/friend is approached to participate in the study, the decision to participate or not will have to be made within this time window.

 

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How is it decided which preventive medications I will use?

Sometimes we do not know which treatment is best for patients. To find out, we need to compare different treatments. We put people into groups and give each group a different treatment. The results are compared to see if one group does better. To try to make sure the groups comparable, each patient is put into a group by chance. In order to ensure this process is performed randomly, the patient and the investigators are not able to influence which treatment group the patient will be in. Using some anonymous information about you, our computer system will randomly allocate you to a group, deciding whether you will take the study medication or not. In PRECIOUS you will be allocated to take either one, two, or all three of the study drugs or to have no study drugs at all. If you are chosen to not receive any study medication then we refer to you as receiving ‘standard care’. This process of random allocation is a crucial part of the research study, because it results in groups of people who are very similar in all respects other than their use of the study medication. This means that any differences in outcome between the two groups in the study are most likely due to their use of the study medication.

 

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Are there are any pre-existing medical conditions that will exclude me from the trial?

If you have a medical condition that requires you to use one of the drugs in this trial (such as an existing infection when you were admitted to hospital), or if you were in a poor medical condition before the stroke, participation in the trial is not allowed. If you have another medical condition that could interact with any of the PRECIOUS drugs, you may still take part in the trial but you will not be put into the group that is treated with the drug in question. The same applies if you are sensitive or allergic to any of the three drugs. Your treating physician will very carefully monitor if you are a suitable candidate.

 

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What will happen if the patient is unable to make a decision about participating in the trial?

Because of the symptoms following a stroke, sometimes patients may not be able to understand the information about the trial or may have difficulty expressing themselves. In these cases the research team may approach a spouse or family member to act as a representative, and will ask for permission to include the patient in the study. If a patient regains his or her ability to decide whether to participate in the research, the patient will be approached and the research team will again ask for consent to participate in the trial. If the patient does not want to participate, he or she will be excluded and any collected test results will not be used.

 

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How will the trial be monitored on the ward?

If you participate in this trial, your treating physician will prescribe the preventive treatment you have been allocated to and your physician will closely monitor if you experience any side effects. Participation in this trial will not affect the standard of care you receive. If there is a clinical need for the use of any of the drugs outside the study, you will receive this treatment as part of your routine hospital care regardless of which PRECIOUS study group you are in.

 

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What are the potential benefits of taking part?

We do not know whether the use of any of the three study drugs is beneficial, but it is possible that they will be. We hope that the results of this study will help us to give better treatment to stroke patients in the future.

 

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What are the possible risks from taking part in the trial?

All three study drugs have been used in clinical practice for many years and previous studies have found them to be safe in patients with acute stroke. However, it is possible that you will experience side effects from the study medication you are allocated. You can ask your treating physician about the most commonly observed side effects and how frequently they occur.

 

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Will the researchers contact me for follow-up? And for how long after participating in the study?

We will contact you one week after treatment (or just before discharge, if this is earlier) and again after around 3 months. In week one, we will assess your level of disability by completing a short interview with you and/or a family member or caregiver. During the first week, we will also collect medical information such as your blood pressures and temperatures, the occurrence of any serious new health problems, and information on other medication you may be using.
At 3 months, we will ask you to return to the outpatient clinic of this hospital or we may meet you at your place of residence or elsewhere. If you come to the hospital, we may pay your travel costs. We will again complete a brief interview to assess your level of disability, quality of life, as well as a short test to assess your cognition. We will also record the locations you have stayed in those 3 months. Together this will take about 30 to 60 minutes. We will only collect health information in this period if it is relevant to the results of PRECIOUS. After the visit at 3 months, your participation in the study is complete.

 

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Why is a part of the visit after 3 months recorded on video?

To measure the long-term outcome of a stroke patient we use a scale called the “modified Rankin Scale (mRS)”, which is a rating for disability and is widely used in research. In order to ensure we make the best outcome measurement, we videotape the interview and send it to 3 different investigators and ask them to score the mRS as well. These investigators do not know the patient or which medication the patient has received. We then take the average of the different scores given by the investigators.
Although the patient’s face will be visible in the video, there will be no mention of his or her identity to ensure that the patient stays anonymous. If the patient is unable to speak, a relative or caregiver may be asked to answer questions about the status of the patient and his or her voice will be recorded. The relative or caregiver will also remain anonymous.

 

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What if I want to stop and leave the trial?

You are free to withdraw from all or part of this study at any time, without giving a reason. If you do decide to withdraw, PRECIOUS will retain the information that was collected about you whilst you were involved in the study. If you need to discuss anything or have any further questions, please contact us (undefinedprecious(at)umcutrecht.nl).

 

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