Clinical trial NCT06648369: Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial
Official title: Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intra Cerebral Hemorrhage
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, randomized-controlled (2:1), two-arm parallel group, open treatment, blinded endpoint clinical trial (PROBE)
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 \[modified Rankin scale (mRS) is ≥4\]
* 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)

Primary outcomes:
measure: Recruitment
timeFrame: 12 months
Secondary outcomes:
measure: Technical feasibility
timeFrame: 12 months
measure: Major Adverse Cardiovascular Events
timeFrame: 30 days
measure: Radiological outcomes
timeFrame: 24 hours
measure: Radiological outcomes
timeFrame: 72 hours
measure: Radiological outcomes
timeFrame: 72 hours
measure: Clinical outcomes
timeFrame: 24 hours
measure: Clinical Outcome
timeFrame: 24 hours
measure: Clinical Outcome
timeFrame: 24 hours
measure: Clinical outcomes
timeFrame: 72 hours
measure: Clinical Outcome
timeFrame: 72 hours
measure: Clinical Outcome
timeFrame: 72 hours
measure: Clinical outcomes
timeFrame: 3 months
measure: Clinical Outcome
timeFrame: 3 months
measure: Clinical outcomes
timeFrame: 6 months
measure: Clinical Outcome
timeFrame: 6 months
measure: Quality of blood pressure control
timeFrame: 60 min
measure: Quality of blood pressure control
timeFrame: 72 hours
measure: Quality of blood pressure control
timeFrame: 72 hours
measure: Quality of blood pressure control
timeFrame: 72 hours
measure: Between group differences
timeFrame: 72 hours
measure: Between group differences
timeFrame: 72 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Bern
Study officials:
affiliation: Department for Neurology, Inselspital, University Hospital Bern
name: David J Seiffge, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: