ANAKINRA for Intracerebral haemorrhage

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years;"}
• {"criterion_text":"- 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);"}
• {"criterion_text":"- Minimal intracerebral haemorrhage volume of 10 mL"}
• {"criterion_text":"- Intervention can be started within 8 hours from symptoms onset;"}
• {"criterion_text":"- Patient's or legal representative's informed consent."}

Exclusion criteria

• {"criterion_text":"- Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma Scale score < 6 at time of consent);"}
• {"criterion_text":"- Standard contraindications to MRI;"}
• {"criterion_text":"- Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration;"}
• {"criterion_text":"- Known allergy to anakinra or other products that are produced by DNA technology using the micro-organism E. coli;"}
• {"criterion_text":"- Live vaccinations within the last 10 days prior to this ICH;"}
• {"criterion_text":"- Severe renal impairment (eGFR <30ml/min/1.73m);"}
• {"criterion_text":"- Known active malignancy"}
• {"criterion_text":"- Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct;"}
• {"criterion_text":"- Planned neurosurgical haematoma evacuation;"}
• {"criterion_text":"- Severe infection at admission, requiring antibiotic treatment;"}
• {"criterion_text":"- Known active tuberculosis or active hepatitis;"}
• {"criterion_text":"- Use of immunosuppressive or immune-modulating therapy at admission;"}
• {"criterion_text":"- Neutropenia (Absolute Neutrophil Count (ANC) <1.5 x 109/L );"}
• {"criterion_text":"- Pre-stroke modified Rankin Scale score ≥ 3;"}
• {"criterion_text":"- Pregnancy or breast-feeding;"}

Primary endpoints

• {"endpoint_text":"- Oedema extension distance (OED) determined with MRI","definition_or_measurement_approach":"Determined with MRI (OED measured on MRI)"}

Secondary endpoints

• {"endpoint_text":"- (serious) Adverse events","definition_or_measurement_approach":""}
• {"endpoint_text":"- Serum inflammatory markers IL-1β, IL-6, hsCRP, neutrophil and total white blood cell counts","definition_or_measurement_approach":"Serum measurement of listed inflammatory markers and full blood counts"}
• {"endpoint_text":"- DCE-MRI measurement of BBB transfer constant (Ktrans)","definition_or_measurement_approach":"Dynamic contrast-enhanced MRI to measure BBB transfer constant Ktrans"}
• {"endpoint_text":"- mRS, Barthel index and EQ-5D-5L score","definition_or_measurement_approach":"Standard clinical outcome scales: modified Rankin Scale (mRS), Barthel Index, and EQ-5D-5L questionnaire"}

Netherlands

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

28-10-2024

Processing Time Days

11

Number Of Sites

3

Number Of Participants

75

Primary sponsor

Full Name

Stichting Radboud universitair medisch centrum

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands