Minimally invasive endoscopic treatment for brain hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of early minimally invasive image-guided endoscopic evacuation of hematomas in patients with spontaneous supratentorial intracerebral hemorrhage (SSICH), compared to best medical treatment alone. The study aims to determine if this approach can improve functional outcomes at six months post-treatment. Participants will undergo a series of assessments, including Glasgow Coma Scale evaluations, throughout the trial. The intervention is designed to be initiated within 24 hours of symptom onset to maximize potential benefits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Spontaneous supratentorial intracerebral hemorrhage (SSICH), defined as the sudden occurrence of bleeding into the lobar parenchyma and/or into the basal ganglia and/or thalamus that may extend into the ventricles confirmed by imaging
* SSICH volume ≥20 mL \<100 mL
* A focal neurological deficit consisting of either

  * clinically relevant hemiparesis (≥4 motor points on the NIHSS for facial palsy, motoric upper and lower extremities combined)
  * clinically relevant motor or sensory aphasia (≥2 points on the NIHSS)
  * clinically relevant hemi-inattention (formerly neglect, 2 points on the NIHSS)
  * decreased level of consciousness (Glasgow Coma Scale (GCS)≤13)
* Presenting GCS 5 - 15 (in intubated patients GCS assessment will be performed after Rutledge et al. or if impossible, the last pre-intubation GCS will be used)
* Endoscopic hematoma evacuation can be initiated within 24 hours after the patient was last seen well/symptom onset
* Informed consent of patient or appropriate surrogate (for patients without competence)

Exclusion Criteria:

* SSICH due to known or suspected structural abnormality in the brain (e.g. vascular malformation, aneurysm, arteriovenous malformation (AVM), brain tumor) and/or brain trauma and/or hemorrhagic conversion of an ischemic infarction
* Multiple simultaneous intracranial hemorrhages (ICH) (e.g. multifocal ICH, chronic subdural hematoma (cSDH), acute subdural hematoma (aSDH), SAH)
* Infratentorial hemorrhage or midbrain extension/involvement of the hemorrhage
* Coagulation disorder (including anticoagulation) with an international normalized ratio (INR) of \>1.5 which cannot be pharmacologically reverted until the planned time of evacuation
* Pregnancy
* Relevant disability prior to SSICH (mRS \>2)
* Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 180 days (e.g. bilateral fixed dilated pupils)

Where it's running

• Department of Neurosurgery, University Hospital Basel
  Basel, Switzerland Recruiting
• University Hospital Bern
  Bern, Switzerland Recruiting
• Hopitaux Universitare Geneve
  Geneva, Switzerland Recruiting
• Centre Hopitalier Universitaire Vaudoise
  Lausanne, Switzerland Recruiting
• Luzerner Kantonsspital
  Lucerne, Switzerland Recruiting
• Ospedale Regionale di Lugano
  Lugano, Switzerland Recruiting

Study contacts

• Principal investigator: Jehuda Soleman, Prof. Dr. med. — Department of Neurosurgery, University Hospital Basel
• Study coordinator: Raphael Guzman, Prof. Dr. med.
• Email: raphael.guzman@usb.ch
• Phone: +41 61 265 33 68

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.