Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT06648369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-18
First Post:
2024-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinded Endpoint Assessment'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, randomized-controlled (2:1), two-arm parallel group, open treatment, blinded endpoint clinical trial (PROBE)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': '12 months', 'description': 'Recruitment rate at 12 months'}], 'secondaryOutcomes': [{'measure': 'Technical feasibility', 'timeFrame': '12 months', 'description': '≥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.'}, {'measure': 'Major Adverse Cardiovascular Events', 'timeFrame': '30 days', 'description': '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)'}, {'measure': 'Radiological outcomes', 'timeFrame': '24 hours', 'description': 'Haematoma expansion at 24 hours'}, {'measure': 'Radiological outcomes', 'timeFrame': '72 hours', 'description': 'Presence and number of new lesions on DWI at 72 hours'}, {'measure': 'Radiological outcomes', 'timeFrame': '72 hours', 'description': 'Absolute and relative PHE volume on FLAIR at 72 hours'}, {'measure': 'Clinical outcomes', 'timeFrame': '24 hours', 'description': 'Mortality at 24 hours'}, {'measure': 'Clinical Outcome', 'timeFrame': '24 hours', 'description': 'Early functional outcome (Modified Rankin Scale (mRS 0-6, no symptoms - death)) at 24 hours'}, {'measure': 'Clinical Outcome', 'timeFrame': '24 hours', 'description': 'Early functional outcome (National Institutes of Health Stroke Scale (NIHSS 0-42, no symptoms - severe stroke)) at 24 hours'}, {'measure': 'Clinical outcomes', 'timeFrame': '72 hours', 'description': 'Mortality at 72 hours'}, {'measure': 'Clinical Outcome', 'timeFrame': '72 hours', 'description': 'Functional outcome (Modified Rankin Scale (mRS 0-6, no symptoms - death)) at 72 hours'}, {'measure': 'Clinical Outcome', 'timeFrame': '72 hours', 'description': 'Functional outcome National Institutes of Health Stroke Scale (NIHSS 0-42, no symptoms - severe stroke)) at 72 hours'}, {'measure': 'Clinical outcomes', 'timeFrame': '3 months', 'description': 'Mortality at 3 months'}, {'measure': 'Clinical Outcome', 'timeFrame': '3 months', 'description': 'Functional outcome (Modified Rankin Scale (mRS 0-6, no symptoms - death)) at 3 months'}, {'measure': 'Clinical outcomes', 'timeFrame': '6 months', 'description': 'Mortality at 6 months'}, {'measure': 'Clinical Outcome', 'timeFrame': '6 months', 'description': 'Functional outcome (Modified Rankin Scale (mRS 0-6, no symptoms - death)) at 6 months'}, {'measure': 'Quality of blood pressure control', 'timeFrame': '60 min', 'description': 'Rapidity (\\<60minutes from randomization to reach target blood pressure level)'}, {'measure': 'Quality of blood pressure control', 'timeFrame': '72 hours', 'description': 'Sustainability (≥70% of time within target blood pressure level during treatment)'}, {'measure': 'Quality of blood pressure control', 'timeFrame': '72 hours', 'description': 'Variability (\\<20% variability of blood pressure level during treatment)'}, {'measure': 'Quality of blood pressure control', 'timeFrame': '72 hours', 'description': 'Hypotensive episodes (time below lower threshold)'}, {'measure': 'Between group differences', 'timeFrame': '72 hours', 'description': 'Treatment delivery (% of patients receiving treatment)'}, {'measure': 'Between group differences', 'timeFrame': '72 hours', 'description': 'Metrics (time to treatment, time to target)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intra Cerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nUltimately, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic imaging proven diagnosis of non-traumatic ICH\n* Vascular imaging (MR-/CT-angiogram or DSA) on admission to rule out high suspicion of macrovascular bleeding source\n* Enrolment no later than 6 hours of symptom onset\n* Age \\>18 years, no upper age limit\n* Informed consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent\n\nExclusion Criteria:\n\n* Palliative care/comfort therapy decision in the emergency department\n* 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)\n* 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)\n* Severe ICH (haematoma volume \\>60ml or GCS \\<8)\n* Haematoma evacuation or decompressive craniectomy within 72 hours planned or highly likely (isolated EVD is not an exclusion criterion)\n* Severe pre-morbid disability \\[modified Rankin scale (mRS) is ≥4\\]\n* Contraindication against the use of tranexamic acid\n* Active participation in another drug or devices trial concurrently\n* Female patient that are either pregnant or breastfeeding\n* Contraindications against Clevidipine (allergy to soja, lipid metabolism defect or known severe aortic stenosis)'}, 'identificationModule': {'nctId': 'NCT06648369', 'acronym': 'MAX-ICH', 'briefTitle': 'Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial', 'orgStudyIdInfo': {'id': 'MAX-ICH pilot trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control arm (usual care)', 'description': 'Control group is treated according to local standard of care', 'interventionNames': ['Other: Standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental arm (MAX-ICH care bundle)', 'description': 'Experimental group is treated according MAX-ICH care bundle', 'interventionNames': ['Other: MAX-ICH care bundle']}], 'interventions': [{'name': 'MAX-ICH care bundle', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Experimental arm (MAX-ICH care bundle)']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Control arm (usual care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'contacts': [{'name': 'David J Seiffge, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'david.seiffge@insel.ch', 'phone': '+41 31 664 05 09'}, {'name': 'Bernhard M Siepen, Dr. med.', 'role': 'CONTACT', 'email': 'bernhard.siepen@insel.ch', 'phone': '+41 31 632 89 61'}], 'facility': 'Inselspital, University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'David J Seiffge, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'david.seiffge@insel.ch', 'phone': '+41 31 66 40 509'}, {'name': 'Bernhard M Siepen, Dr. med.', 'role': 'CONTACT', 'email': 'bernhard.siepen@insel.ch', 'phone': '+41 31 63 24 220'}], 'overallOfficials': [{'name': 'David J Seiffge, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department for Neurology, Inselspital, University Hospital Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}