A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage

Korábbi kezelés

• Planned neurosurgical hematoma evacuation or other urgent surgical intervention (i.e., surgical relief of increased intracranial pressure) on initial presentation.
• Use of immunosuppressive or immune-modulating therapy at admission (e.g., steroids, methotrexate, monoclonal antibodies, etc).

Más betegség

• History of personal or familial bleeding disorders; including prolonged or unusual bleeding.
• Patients with intraventricular haemorrhage (IVH) having a Graeb score of \>3 on initial presentation. Patients must not have blood in the 4th ventricle and may only have blood in the 3rd ventricle in the absence of ventricular expansion. Trace or mild haemorrhage in either or both lateral ventricles is permitted. Patients with hydrocephalus determined radiologically on initial presentation are excluded regardless of Graeb score.
• Patients with active systemic bacterial, viral or fungal infections.

Laborértékek

• Severe renal impairment (eGFR \< 30 mL/min/1.73 m2).

Egyéb

• Known deficiency in factor XII (FXII) or haemophilia type A (FVII) or type B (FIX) or type C (FXI).
• Infratentorial (midbrain, pons, medulla, or cerebellum) ICH.
• Secondary ICH due to aneurysm, brain tumour, arteriovenous malformation, thrombocytopenia, coagulopathy, acute sepsis, traumatic brain injury (TBI), or disseminated intravascular coagulation (DIC).
• Anticoagulation reversal treatment.
• Women of childbearing potential.
• Have a body weight \> 120 kg at screening.

• Male or female patients aged ≥ 18 years.
• Written informed consent obtained before any study assessment. If the patient is not able to give the informed consent personally, consent by a legal representative as defined by local law and regulation is acceptable.
• First-ever, spontaneous, supratentorial intracerebral haemorrhage in cerebral cortex or deep brain structures (putamen, thalamus, caudate, and associated deep white matter tracts) with a volume ≥ 5 mL and ≤ 60 mL determined by non-contrast CT scan.
• Patients with Glasgow Coma Scale (GCS) best motor score no less than 5.
• Modified Rankin Scale (mRS) score 0-2 prior to ICH symptom onset.