Studying Anakinra to Reduce Secondary Brain Damage After Spontaneous Haemorrhagic Stroke (NCT04834388) | Clinical Trial Compass
UnknownPhase 2
Studying Anakinra to Reduce Secondary Brain Damage After Spontaneous Haemorrhagic Stroke
Netherlands75 participantsStarted 2022-08-10
Plain-language summary
The goal of this clinical trial\] is to determine if anakinra can ameliorate the formation of perihaematomal oedema in patients with spontaneous intracerebral haemorrhage (ICH). The main aims are:
* To determine the effect of high-dose versus low-dose anakinra compared to standard medical management on perihaematomal oedema formation in the first week after ICH.
* Determine the safety profile of anakinra in these patients
* Study the effect of anakinra treatment on inflammation markers, blood-brain-barrier permeability and functional outcome.
Researchers will compare treatment with anakinra for three days, in either a low or high dose, with standard medical care after ICH. Participants will:
* Be randomized to receive anakinra during three days, or receive standard medical care
* Undergo a MRI scan seven days after their ICH
* Take part in a telephone interview their functional performance three months later.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years;
. Supratentorial non-traumatic ICH confirmed by CT, without a confirmed causative lesion on admission CT-angiography (e.g. aneurysm, AVM, DAVF, cerebral venous sinus thrombosis) or other known underlying lesion (e.g. tumour, cavernoma);
. Minimal intracerebral haemorrhage volume of 10 mL;
. Intervention can be started within 8 hours from symptoms onset;
. Patient's or legal representative's informed consent.
Exclusion criteria
. Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma Scale score \< 6 at time of consent);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.