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Clinical trial Recruiting at 1 site Interventional Ages 18 to 100

Maximal Medical Care for Intracerebral Hemorrhage (ICH) – Pilot

Official title: Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial

Run by Insel Gruppe AG, University Hospital Bern · NCT06648369 · Data updated 2026-11-12

This pilot test checks whether a maximal medical care bundle for ICH patients is feasible and safe to use in the first 72 hours.

More Intra Cerebral Hemorrhage trials

Quick facts

Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment50 (estimated)
SponsorInsel Gruppe AG, University Hospital Bern
Academic / other
Locations1 site (Bern)
StatusRecruiting
StartedAugust 7, 2025
Main results expectedNovember 30, 2028
Study endsNovember 30, 2028
Registry record updatedJuly 2, 2026
Trial IDNCT06648369 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with symptomatic, non-traumatic intracerebral hemorrhage confirmed by imaging, enrolled within 6 hours of symptom onset, and without exclusion criteria such as large hematoma or poor prognosis.

Probably not a fit

Patients with severe criteria (e.g., hematoma >60 mL, GCS <8) or those with conditions excluding invasive interventions may not benefit from the MAX-ICH approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This monocentric, phase-II pilot study tests a comprehensive MAX-ICH care bundle for adults with non-traumatic intracerebral hemorrhage. The trial focuses on feasibility of rapid, multi-component management within 6 hours of onset, including intensive blood pressure control, rapid reversal of anticoagulation, and tranexamic acid administration, alongside standard care. Primary aim is to recruit participants within 12 months and achieve at least 70% protocol adherence, with safety monitored through major adverse cardiovascular events and exploration of clinical outcomes. The study compares the MAX-ICH bundle to standard care to assess potential improvements in hematoma management and early outcomes. Recruitment, safety, and adherence data will guide future larger trials.

Why it matters

Potential benefit: If successful, the MAX-ICH bundle could improve early management and outcomes for ICH patients by reducing hematoma growth and early mortality.

How similar studies have gone: Prior single interventions showed signals of benefit on secondary outcomes, but the comprehensive MAX-ICH bundle is a novel, integrative approach awaiting confirmation.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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)

Where it's running

  • Inselspital, University Hospital Bern
    Bern, Switzerland     Recruiting

Study contacts

  • Principal investigator: David J Seiffge, Prof. Dr. med. — Department for Neurology, Inselspital, University Hospital Bern
  • Study coordinator: David J Seiffge, Prof. Dr. med.
  • Email: david.seiffge@insel.ch
  • Phone: +41 31 66 40 509

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Intra Cerebral Hemorrhage 4Insel Gruppe AG, University Hospital Bern 140
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.