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)
Parallel
MAX-ICH care bundle
Other interventionThe MAX-ICH care bundle is a comprehensive treatment approach for intracerebral hemorrhage (ICH). Patients receive 72 hours of care in a high-dependency unit like an ICU or hyperacute stroke unit. Intensive blood pressure control is used if systolic blood pressure exceeds 140mmHg, with rapid reduction to below 140mmHg within 60 minutes, and maintenance at or above 110mmHg for at least 75% of the time, with variability kept under 20%. The protocol includes rapid reversal of anticoagulation within 60 minutes, administration of tranexamic acid (1g bolus within 60 minutes, followed by 1g over 8 hours), and neurosurgical evaluation within 60 minutes. Additionally, family counseling is provided to avoid Do-Not-Resuscitate orders during the first 72 hours.
Standard of care
Other interventionThe control group will be treated according to the hospital's standard protocol for patients with spontaneous intracerebral hemorrhage, based on the guidelines of the European Stroke Organisation (ESO). The ESO develops evidence-based recommendations for the optimal care of stroke patients. The recommended immediate measures include: immediate stabilization and assessment, blood pressure control and reduction, brain imaging, surgical intervention for large hemorrhages, coagulation control, and monitoring of intracranial pressure. The specific application of these measures varies depending on the hospital and the treating physicians.
Recruitment
Recruitment rate at 12 months
Technical feasibility
≥70% compliance with MAX-ICH care bundle at 72 hours (experimental group only). Full compliance is defined as all 6 criteria of the MAX-ICH care bundle (for details see study intervention) are fulfilled. After the 12 months recruitment period the percentage of patients for which full compliance at 72h afer randomization to the care bundle group was achieved will be determined.
Major Adverse Cardiovascular Events
MACE within the first 30 days (i.e. Death, acute coronary syndrome (ACS) or myocardial infarction (MI), deep vein thrombosis (DVT), Pulmonary embolism (PE), VTE (combined DVT/PE), Ischaemic stroke)
Radiological outcomes
Haematoma expansion at 24 hours
Radiological outcomes
Presence and number of new lesions on DWI at 72 hours
Click on the lead sponsor to view all of their trials.
