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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Inselspital, University Hospital Bern
RECRUITING
Bern
Contact Information
Primary
David J Seiffge, Prof. Dr. med.
david.seiffge@insel.ch
+41 31 66 40 509
Backup
Bernhard M Siepen, Dr. med.
bernhard.siepen@insel.ch
+41 31 63 24 220
Time Frame
Start Date: 2025-08-07
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 50
Treatments
Other: Control arm (usual care)
Control group is treated according to local standard of care
Experimental: Experimental arm (MAX-ICH care bundle)
Experimental group is treated according MAX-ICH care bundle
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov