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Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial

RecruitingNAAges 18 Years - 100 YearsAllInsel Gruppe AG, University Hospital Bern
NCT06648369 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Informed consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent Exclusion Criteria: * 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) * Haematoma evacuation or decompressive craniectomy within 72 hours planned or highly likely (isolated EVD is not an exclusion criterion) * Severe pre-morbid disability \[modified Rankin scale (mRS) is ≥4\] * Contraindication against the use of tranexamic acid * Active participation in another drug or devices trial concurrently * Female patient that are either pregnant or breastfeeding * Contraindications against Clevidipine (allergy to soja, lipid metabolism defect or known severe aortic stenosis)
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What it tests

  • MAX-ICH care bundle
  • Standard of care
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Where

1 site
Inselspital, University Hospital Bern
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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