Intra Cerebral HemorrhageMAX-ICHNCT06648369
Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial
A study testing MAX-ICH care bundle in people with Intra Cerebral Hemorrhage, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intra Cerebral Hemorrhage
- What is being tested?
- MAX-ICH care bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Aug 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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]
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, University Hospital Bern
Bern, 3010
David J Seiffge, Prof. Dr. med., +41 31 664 05 09, david.seiffge@insel.ch
Bernhard M Siepen, Dr. med., +41 31 632 89 61, bernhard.siepen@insel.ch
About this study
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.
Read the detailed description
The MAX-ICH pilot trial is a monocentric, phase-II study designed to evaluate the feasibility and safety of a "maximal medical treatment" care bundle for patients suffering from intracerebral hemorrhage (ICH). ICH is a condition with a notably high rate of mortality and morbidity, and this trial aims to improve outcomes for these patients by utilizing a comprehensive approach to their treatment. Previous clinical trials concentrated on single interventions, such as blood pressure control and the administration of tranexamic acid (TXA) therapy. While these interventions did not achieve their primary efficacy outcomes, they did demonstrate beneficial effects on secondary measures like reducing hematoma expansion and early mortality. The current study builds on this prior research by integrating advanced interventions into a unified and comprehensive care bundle, termed MAX-ICH, with the goal of potentially enhancing patient outcomes.
The primary objective of the trial is to demonstrate the feasibility of recruiting patients within a 12-month period. In addition to this, secondary objectives include assessing the technical feasibility of protocol adherence, targeting a compliance rate of at least 70%. The study will also monitor safety by tracking major adverse cardiovascular events (MACE) and explore a range of clinical outcomes, treatment metrics, and differences between the experimental group receiving the MAX-ICH care bundle and those receiving standard care.
The MAX-ICH care bundle consists of several key components designed to deliver intensive and timely care. Patients will receive 72 hours of treatment in a high-dependency unit, ensuring continuous monitoring and rapid responses to any changes in their condition. Intensive blood pressure control will be implemented through intra-arterial monitoring to maintain stability. If a patient is on anticoagulant therapy, the care bundle mandates rapid reversal of anticoagulation within 60 minutes of presentation. Similarly, tranexamic acid will be administered within 60 minutes, helping to mitigate further hemorrhage. Neurosurgical evaluation will also be conducted within 60 minutes to determine if surgical intervention is warranted. Additionally, counseling will be provided to avoid placing Do-Not-Resuscitate (DNR) orders during the critical first 72 hours, allowing time for the intensive interventions to take effect.
Ultimately, this study aims to determine whether the MAX-ICH care bundle can be feasibly implemented in clinical practice and whether its structured, intensive approach within the first 72 hours of care can lead to improved outcomes for patients with ICH.
- Conditions
- Intra Cerebral Hemorrhage
- Being tested
- MAX-ICH care bundle, Standard of care
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAX-ICH care bundleOther
The MAX-ICH care bundle is a comprehensive treatment approach for intracerebral hemorrhage (ICH). Patients receive 72 hours of care in a high-dependency unit like an ICU or hyperacute stroke unit. Intensive blood pressure control is used if systolic blood pressure exceeds 140mmHg, with rapid reduction to below 140mmHg within 60 minutes, and maintenance at or above 110mmHg for at least 75% of the time, with variability kept under 20%. The protocol includes rapid reversal of anticoagulation within 60 minutes, administration of tranexamic acid (1g bolus within 60 minutes, followed by 1g over 8 hours), and neurosurgical evaluation within 60 minutes. Additionally, family counseling is provided to avoid Do-Not-Resuscitate orders during the first 72 hours.
Standard of careOther
The control group will be treated according to the hospital's standard protocol for patients with spontaneous intracerebral hemorrhage, based on the guidelines of the European Stroke Organisation (ESO). The ESO develops evidence-based recommendations for the optimal care of stroke patients. The recommended immediate measures include: immediate stabilization and assessment, blood pressure control and reduction, brain imaging, surgical intervention for large hemorrhages, coagulation control, and monitoring of intracranial pressure. The specific application of these measures varies depending on the hospital and the treating physicians.
| Study group | Role | What they receive |
|---|---|---|
| Control arm (usual care) | Other | Control group is treated according to local standard of care Receives: Other: Standard of care |
| Experimental arm (MAX-ICH care bundle) | Experimental | Experimental group is treated according MAX-ICH care bundle Receives: Other: MAX-ICH care bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment rate at 12 months
Measured: 12 months
Secondary outcomes (21)
Technical feasibility
≥70% compliance with MAX-ICH care bundle at 72 hours (experimental group only). Full compliance is defined as all 6 criteria of the MAX-ICH care bundle (for details see study intervention) are fulfilled. After the 12 months recruitment period the percentage of patients for which full compliance at 72h afer randomization to the care bundle group was achieved will be determined.
Measured: 12 months
Major Adverse Cardiovascular Events
MACE within the first 30 days (i.e. Death, acute coronary syndrome (ACS) or myocardial infarction (MI), deep vein thrombosis (DVT), Pulmonary embolism (PE), VTE (combined DVT/PE), Ischaemic stroke)
Measured: 30 days
Radiological outcomes
Haematoma expansion at 24 hours
Measured: 24 hours
Radiological outcomes
Presence and number of new lesions on DWI at 72 hours
Measured: 72 hours
Radiological outcomes
Absolute and relative PHE volume on FLAIR at 72 hours
Measured: 72 hours
Clinical outcomes
Mortality at 24 hours
Measured: 24 hours
Clinical Outcome
Early functional outcome (Modified Rankin Scale (mRS 0-6, no symptoms - death)) at 24 hours
Measured: 24 hours
Clinical Outcome
Early functional outcome (National Institutes of Health Stroke Scale (NIHSS 0-42, no symptoms - severe stroke)) at 24 hours
Measured: 24 hours
Clinical outcomes
Mortality at 72 hours
Measured: 72 hours
Clinical Outcome
Functional outcome (Modified Rankin Scale (mRS 0-6, no symptoms - death)) at 72 hours
Measured: 72 hours
Clinical Outcome
Functional outcome National Institutes of Health Stroke Scale (NIHSS 0-42, no symptoms - severe stroke)) at 72 hours
Measured: 72 hours
Clinical outcomes
Mortality at 3 months
Measured: 3 months
Clinical Outcome
Functional outcome (Modified Rankin Scale (mRS 0-6, no symptoms - death)) at 3 months
Measured: 3 months
Clinical outcomes
Mortality at 6 months
Measured: 6 months
Clinical Outcome
Functional outcome (Modified Rankin Scale (mRS 0-6, no symptoms - death)) at 6 months
Measured: 6 months
Quality of blood pressure control
Rapidity (<60minutes from randomization to reach target blood pressure level)
Measured: 60 min
Quality of blood pressure control
Sustainability (≥75% of time within target blood pressure level during treatment)
Measured: 72 hours
Quality of blood pressure control
Variability (<20% variability of blood pressure level during treatment)
Measured: 72 hours
Quality of blood pressure control
Hypotensive episodes (time below lower threshold)
Measured: 72 hours
Between group differences
Treatment delivery (% of patients receiving treatment)
Measured: 72 hours
Between group differences
Metrics (time to treatment, time to target)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start7 Aug 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized-controlled (2:1), two-arm parallel group, open treatment, blinded endpoint clinical trial (PROBE)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J Seiffge, Prof. Dr. med., Principal investigator, Department for Neurology, Inselspital, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648369
- Sponsor's protocol ID
- MAX-ICH pilot trial
- Acronym
- MAX-ICH
- Status last verified
- Jun 2026
- First submitted
- 20 Aug 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial
- ClinicalTrials.gov ID
- NCT06648369
- Acronym / sponsor ID
- MAX-ICH / MAX-ICH pilot trial
- Conditions
- Intra Cerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The MAX-ICH pilot trial is a monocentric, phase-II study designed to evaluate the feasibility and safety of a "maximal medical treatment" care bundle for patients suffering from intracerebral hemorrhage (ICH). ICH is a condition with a notably high rate of mortality and morbidity, and this trial aims to improve outcomes for these patients by utilizing a comprehensive approach to their treatment. Previous clinical trials concentrated on single interventions, such as blood pressure control and the administration of tranexamic acid (TXA) therapy. While these interventions did not achieve their primary efficacy outcomes, they did demonstrate beneficial effects on secondary measures like reducing hematoma expansion and early mortality. The current study builds on this prior research by integrating advanced interventions into a unified and comprehensive care bundle, termed MAX-ICH, with the goal of potentially enhancing patient outcomes.
The primary objective of the trial is to demonstrate the feasibility of recruiting patients within a 12-month period. In addition to this, secondary objectives include assessing the technical feasibility of protocol adherence, targeting a compliance rate of at least 70%. The study will also monitor safety by tracking major adverse cardiovascular events (MACE) and explore a range of clinical outcomes, treatment metrics, and differences between the experimental group receiving the MAX-ICH care bundle and those receiving standard care.
The MAX-ICH care bundle consists of several key components designed to deliver intensive and timely care. Patients will receive 72 hours of treatment in a high-dependency unit, ensuring continuous monitoring and rapid responses to any changes in their condition. Intensive blood pressure control will be implemented through intra-arterial monitoring to maintain stability. If a patient is on anticoagulant therapy, the care bundle mandates rapid reversal of anticoagulation within 60 minutes of presentation. Similarly, tranexamic acid will be administered within 60 minutes, helping to mitigate further hemorrhage. Neurosurgical evaluation will also be conducted within 60 minutes to determine if surgical intervention is warranted. Additionally, counseling will be provided to avoid placing Do-Not-Resuscitate (DNR) orders during the critical first 72 hours, allowing time for the intensive interventions to take effect.
Ultimately, this study aims to determine whether the MAX-ICH care bundle can be feasibly implemented in clinical practice and whether its structured, intensive approach within the first 72 hours of care can lead to improved outcomes for patients with ICH.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, randomized-controlled (2:1), two-arm parallel group, open treatment, blinded endpoint clinical trial (PROBE)
| Arm | Type | Receives |
|---|---|---|
| Control arm (usual care) | Other | Other: Standard of careControl group is treated according to local standard of care |
| Experimental arm (MAX-ICH care bundle) | Experimental | Other: MAX-ICH care bundleExperimental group is treated according MAX-ICH care bundle |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAX-ICH care bundleThe MAX-ICH care bundle is a comprehensive treatment approach for intracerebral hemorrhage (ICH). Patients receive 72 hours of care in a high-dependency unit like an ICU or hyperacute stroke unit. Intensive blood pressure control is used if systolic blood pressure exceeds 140mmHg, with rapid reduction to below 140mmHg within 60 minutes, and maintenance at or above 110mmHg for at least 75% of the time, with variability kept under 20%. The protocol includes rapid reversal of anticoagulation within 60 minutes, administration of tranexamic acid (1g bolus within 60 minutes, followed by 1g over 8 hours), and neurosurgical evaluation within 60 minutes. Additionally, family counseling is provided to avoid Do-Not-Resuscitate orders during the first 72 hours. | Other | Experimental arm (MAX-ICH care bundle) |
| Standard of careThe control group will be treated according to the hospital's standard protocol for patients with spontaneous intracerebral hemorrhage, based on the guidelines of the European Stroke Organisation (ESO). The ESO develops evidence-based recommendations for the optimal care of stroke patients. The recommended immediate measures include: immediate stabilization and assessment, blood pressure control and reduction, brain imaging, surgical intervention for large hemorrhages, coagulation control, and monitoring of intracranial pressure. The specific application of these measures varies depending on the hospital and the treating physicians. | Other | Control arm (usual care) |
Primary outcome
Recruitment
Time frame: 12 months
Recruitment rate at 12 months
21 secondary outcomes
Technical feasibility
Time frame: 12 months
Major Adverse Cardiovascular Events
Time frame: 30 days
Radiological outcomes
Time frame: 24 hours
Radiological outcomes
Time frame: 72 hours
Radiological outcomes
Time frame: 72 hours
Clinical outcomes
Time frame: 24 hours
Clinical Outcome
Time frame: 24 hours
Clinical Outcome
Time frame: 24 hours
Clinical outcomes
Time frame: 72 hours
Clinical Outcome
Time frame: 72 hours
Clinical Outcome
Time frame: 72 hours
Clinical outcomes
Time frame: 3 months
Clinical Outcome
Time frame: 3 months
Clinical outcomes
Time frame: 6 months
Clinical Outcome
Time frame: 6 months
Quality of blood pressure control
Time frame: 60 min
Quality of blood pressure control
Time frame: 72 hours
Quality of blood pressure control
Time frame: 72 hours
Quality of blood pressure control
Time frame: 72 hours
Between group differences
Time frame: 72 hours
Between group differences
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No. Not shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David J Seiffge, Prof. Dr. med. principal investigator
Department for Neurology, Inselspital, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAX-ICH care bundle in people with Intra Cerebral Hemorrhage, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David J Seiffge, Prof. Dr. med. (+41 31 66 40 509, david.seiffge@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.