The MAX-ICH pilot trial is a phase-II study aimed at assessing the feasibility and safety of a comprehensive care bundle for patients with intracerebral hemorrhage (ICH). This "maximal medical treatment" approach combines advanced interventions like intensive blood pressure control, rapid anticoagulation reversal, and tranexamic acid administration to potentially improve outcomes. The primary objective is to evaluate recruitment feasibility over 12 months, while secondary objectives include protocol adherence, safety monitoring, and the exploration of clinical outcomes. The study focuses on the critical first 72 hours of care to determine if this approach can be effectively implemented in clinical practice.
Symptomatic imaging proven diagnosis of non-traumatic ICH
Vascular imaging (MR-/CT-angiogram or DSA) on admission to rule out high suspicion of macrovascular bleeding source
Enrolment no later than 6 hours of symptom onset
Age >18 years, no upper age limit
Palliative care/comfort therapy decision in the emergency department
ICH due to trauma (major head trauma <24 hours of symptom onset causing loss of consciousness and thought to be sufficient to have caused the intracerebral bleeding)
High suspicion of ICH due to arteriovenous malformation (AVM), aneurysm or sinus-venous-thrombosis confirmed by neuroimaging, brain tumor, vasculitis, RCVS/PRES or system disease (liver disease, inherit coagulopathy)
Severe ICH (haematoma volume >60ml or GCS <8)