Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial

NCT06648369 | Not Yet Recruiting

• 1 other identifier: MAX-ICH pilot trial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Intra Cerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Recruitment

  Recruitment rate at 12 months

  12 months

Secondary Outcomes (21)

• Technical feasibility

  12 months

• Major Adverse Cardiovascular Events

  30 days

• Radiological outcomes

  24 hours

• Radiological outcomes

  72 hours

• Radiological outcomes

  72 hours

Study Arms (2)

Control arm (usual care)

OTHER

Control group is treated according to local standard of care

Other: Standard of care

Experimental arm (MAX-ICH care bundle)

EXPERIMENTAL

Experimental group is treated according MAX-ICH care bundle

Other: MAX-ICH care bundle

Interventions

MAX-ICH care bundle OTHER

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.

Experimental arm (MAX-ICH care bundle)

Standard of care OTHER

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.

Control arm (usual care)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• David J Seiffge, Prof. Dr. med.

  Department for Neurology, Inselspital, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David J Seiffge, Prof. Dr. med.

CONTACT

+41 31 66 40 509; david.seiffge@insel.ch

Bernhard M Siepen, Dr. med.

CONTACT

+41 31 63 24 220; bernhard.siepen@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded Endpoint Assessment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, randomized-controlled (2:1), two-arm parallel group, open treatment, blinded endpoint clinical trial (PROBE)

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: October 18, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)