NCT06648369

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	MAX-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.
OTHER	Standard 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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-10-18
• Last updated: 2024-10-18

Locations

1 site across 1 country: Switzerland