RecruitingNot ApplicableNCT06648369

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

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

50 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

Intra Cerebral Hemorrhage

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying MAX-ICH care bundle and Standard of care for people with intra cerebral hemorrhage. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMAX-ICH care bundle

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.

OTHERStandard of care

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.