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Anakinra in Cerebral haemorrhage to Target secondary Injury resulting from Neuroinflammation - a phase II clinical trial
EU CTIS ID: 2024-517230-17-00
What this study is testing
To determine the effect of high-dose versus low-dose anakinra compared to standard medical management on cerebral oedema development after spontaneous supratentorial intracerebral haemorrhage.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma Scale score < 6 at time of consent);
- Standard contraindications to MRI;
- Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration;
- Known allergy to anakinra or other products that are produced by DNA technology using the micro-organism E. coli;
- Live vaccinations within the last 10 days prior to this ICH;
- Severe renal impairment (eGFR <30ml/min/1.73m);
See the full eligibility 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.
- Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma Scale score < 6 at time of consent);
- Standard contraindications to MRI;
- Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration;
- Known allergy to anakinra or other products that are produced by DNA technology using the micro-organism E. coli;
- Live vaccinations within the last 10 days prior to this ICH;
- Severe renal impairment (eGFR <30ml/min/1.73m);
- Known active malignancy
- Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct;
- Planned neurosurgical haematoma evacuation;
- Severe infection at admission, requiring antibiotic treatment;
- Known active tuberculosis or active hepatitis;
- Use of immunosuppressive or immune-modulating therapy at admission;
- Neutropenia (Absolute Neutrophil Count (ANC) <1.5 x 109/L );
- Pre-stroke modified Rankin Scale score ≥ 3;
- Pregnancy or breast-feeding;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.