Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial (NCT06648369) | Clinical Trial Compass
RecruitingNot Applicable
Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial
Switzerland50 participantsStarted 2025-08-07
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.