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 range18 Years
SexALL
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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);
✕. Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct;
✕. Planned neurosurgical haematoma evacuation;
✕. Severe infection at admission, requiring antibiotic treatment;