NCT06648369 Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial
| NCT ID | NCT06648369 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Intra Cerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-08-07 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
David J Seiffge, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
Department for Neurology, Inselspital, University Hospital Bern
Frequently Asked Questions
Who can join the NCT06648369 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Intra Cerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06648369 currently recruiting?
Yes, NCT06648369 is actively recruiting participants. Contact the research team at david.seiffge@insel.ch for enrollment information.
Where is the NCT06648369 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06648369 clinical trial?
NCT06648369 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is David J Seiffge, Prof. Dr. med. at Department for Neurology, Inselspital, University Hospital Bern. The trial plans to enroll 50 participants.