Information for participants
Why do we conduct this
study?
Spontaneous brain bleedings are the second most common form of stroke and affect around 2,500 patients per year in Switzerland. A year after a brain bleeding, around half of these patients are deceased, while the other half suffer severe neurological impairments. To date, there is no therapy that can adequately treat brain bleedings. The current standard of care is the so-called best medical treatment, which consists of a combination of blood pressure managment, intensive care and early rehabilitation. Open brain surgery is the current mainstay of surgical care. Neither the best medical nor surgical therapy could show a satisfactory improvement of survival or disability rates so far. Endoscopic hematoma evacuation, on the other hand, appears to be favourable for survival and disability rates in small studies. However, this has not been proven in large confirmatory studies. The EMINENT-ICH trial aims to close this gap.
What do we want to achieve with the EMINENT-ICH study?
With the EMINENT-ICH study, we want to show that endoscopic hematoma evacuation in addition to best medical therapy leads to less disability in everyday life and better survival rates than could be achieved with best medical therapy alone.
What makes the EMINENT-ICH study special?
During the planning of this study, we worked intensively with affected patients, relatives of affected patients and representatives of patient organizations in order to conduct this study in a patient-oriented and pragmatic manner. We were able to identify study endpoints that are important to patients and relatives and incorporated these into our study design.
Who can participate in the study?
Patients who have a brain bleeding and meet the following criteria can participate in the study.
Inclusion criteria
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Age between ≥18 and <85 years
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Spontaneous brain bleeding with at least 20mL volume
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A neurological impairment must be present, e.g. hemiplegia
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The operation can be initiated within 24 hours of the start of bleeding
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Confirmation of participation is given
Exclusion criteria
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Bleeding in the brain due to a tumor, aneurysm or something similar
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Cerebellar hemorrhages
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Pre-existing disability
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Pregnancy
Risks and opportunities
A large part of the risks in this study can be attributed to the underlying disease of brain bleeding. Brain bleedings are serious illnesses that often lead to persisting disability or even death.
Nevertheless, there are rare risks associated with the operation, such as secondary bleeding or wound infections in the area of the surgical site. The study team or your treating neurosurgeon can advise you on further, specific risks.
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In this study we minimize the risk as much as possible by giving all patients the current standard treatment. Furthermore, you could (but do not have to) benefit from the operation, which could lead to less disability in everyday life.
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In summary, the greatest risks in this study is the underlying disease (brain bleeding), which can lead to permanent disability.
What does it mean to participate in the trial?
If you are included in the study, you will be assigned to a treatment group. This is either the best medical therapy or the best medical therapy plus endoscopic hematoma evacuation. The allocation to the group is done randomly, which is crucial for the scientific quality of the study and the even distribution of participants. ​If you are assigned to the best medical treatment group, you will immediately receive your therapy and be examined by the study team. If you are assigned in the surgical treatment group, in addition to best medical therapy, you will have surgery within 24 hours of the start of bleeding. ​In both groups you will be examined during your hospital stay, blood will be taken before and after the operation and you will be cared for in the intensive care unit or stroke unit. Depending on how well you recover during your hospitalization, you may go to rehabilitation or go home directly. You will be scheduled for routine examinations after 3 and 6 months.
Together with affected patients and their relatives, we have identified outcomes that are relevant for you and we will thus ask you questions regarding your satisfaction and quality of life throughout the study.
With the exception of the questionnaires and blood sampling, all examinations are standard treatment for brain bleedings.
