Intensive care protocol aims to tame brain hemorrhage in first critical hours
NCT ID NCT06648369
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This trial investigates a 'maximal medical treatment' bundle for people with intracerebral hemorrhage (bleeding in the brain). The bundle includes rapid blood pressure control, reversal of blood thinners, and a drug to reduce bleeding, all delivered within the first 72 hours in a high-dependency unit. The study enrolls adults with non-traumatic brain bleeding within 6 hours of symptom onset and aims to see if this intensive approach is feasible and safe. If it works, it could lead to better outcomes for a condition that currently has limited treatment options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MAX-ICH care bundle (intensive blood pressure control, anticoagulation reversal, tranexamic acid)
- What this could lead to
- If successful, this approach could become a standard treatment to reduce disability and death from intracerebral hemorrhage.
- What could go wrong
- This is a small pilot study focused on feasibility, not yet on proving effectiveness. The intensive protocol may be difficult to implement in all hospitals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Inselspital, University Hospital Bern
RECRUITINGBern, 3010, Switzerland
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