Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)

Last updated: July 19, 2024
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Stroke

Brain Injury

Treatment

Early minimally invasive image guided endoscopic hematoma evacuation

Best medical treatment (BMT)

Clinical Study ID

NCT05681988
2022-02216; ko22Guzman
  • Ages 18-85
  • All Genders

Study Summary

This is an open-labelled, single centre randomised controlled trial evaluating the efficacy of early minimally invasive image-guided hematoma evacuation in combination with the current best medical treatment compared to best medical treatment alone in improving functional outcome rates at 6 months after initial treatment in patients with spontaneous supratentorial intracerebral haemorrhage.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Spontaneous supratentorial intracerebral hemorrhage (SSICH), defined as the suddenoccurrence of bleeding into the lobar parenchyma and/or into the basal gangliaand/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 afterRutledge et al. or if impossible, the last pre-intubation GCS will be used)

  • Endoscopic hematoma evacuation can be initiated within 24 hours after the patientwas last seen well/symptom onset

  • Informed consent of patient or appropriate surrogate (for patients withoutcompetence)

Exclusion

Exclusion Criteria:

  • SSICH due to known or suspected structural abnormality in the brain (e.g. vascularmalformation, aneurysm, arteriovenous malformation (AVM), brain tumor) and/or braintrauma and/or hemorrhagic conversion of an ischemic infarction

  • Multiple simultaneous intracranial hemorrhages (ICH) (e.g. multifocal ICH, chronicsubdural hematoma (cSDH), acute subdural hematoma (aSDH), SAH)

  • Infratentorial hemorrhage or midbrain extension/involvement of the hemorrhage

  • Coagulation disorder (including anticoagulation) with an international normalizedratio (INR) of >1.5 which cannot be pharmacologically reverted until the plannedtime of evacuation

  • Pregnancy

  • Relevant disability prior to SSICH (mRS >2)

  • Any comorbid disease or condition expected to compromise survival or ability tocomplete follow-up assessments through 180 days (e.g. bilateral fixed dilatedpupils)

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Early minimally invasive image guided endoscopic hematoma evacuation
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2029

Study Description

Spontaneous supratentorial intracerebral haemorrhage (SSICH) is the second most common form of stroke and accounts for approximately 2500 cases in Switzerland annually. The prognosis is very poor with nearly half of the patients dying within one year after haemorrhage. Treatment options for SSICH consist of either the current gold standard, best medical treatment (BMT), or surgical hematoma evacuation. Neither the best medical treatment nor the established surgical mainstay (conventional craniotomy) have shown relevant improvement of survival or functional outcome rates. A minimal invasive approach with early image-guided endoscopic surgery conducted within 24 hours after bleeding onset is therefore proposed. Endoscopic surgery was shown to be safe and effective, however large trials analyzing the benefits of endoscopic surgery are lacking. An earlier, more complete and more rapid hematoma evacuation could improve the functional outcome and mortality rates in affected patients. The primary objective of this two-armed, open-labelled, single centre randomised controlled trial is to show superiority of early minimally invasive image-guided hematoma evacuation additionally to BMT compared to BMT alone in improving functional outcome rates at 6 months in patients with SSICH. The study procedures include 6 visits in total, 4 of them during hospital stay, 2 of them as follow-up visits within the clinical routine. Each visit consists of assessing Glasgow Coma Scale (GCS), modified Rankin Scale (mRS) and National Institute of Health Stroke Scale (NIHSS), three visits include CT scans (before intervention, directly postoperative and during follow up) and blood sampling (before intervention, postoperative and during follow up). Three visits include assessing patient satisfaction and cognition, and two visits include patient quality of life assessments. This study was designed in collaboration with Patient and Public representatives.

Connect with a study center

  • Department of Neurosurgery, University Hospital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • University Hospital Bern

    Bern,
    Switzerland

    Active - Recruiting

  • Hopitaux Universitare Geneve

    Geneva,
    Switzerland

    Active - Recruiting

  • Centre Hopitalier Universitaire Vaudoise

    Lausanne,
    Switzerland

    Active - Recruiting

  • Ospedale Regionale di Lugano

    Lugano,
    Switzerland

    Active - Recruiting

  • Luzerner Kantonsspital

    Luzern,
    Switzerland

    Active - Recruiting

  • Kantonsspital St. Gallen

    Saint Gallen,
    Switzerland

    Active - Recruiting

  • Centre Hopitalier Universitaire du Valais Romand

    Sion,
    Switzerland

    Active - Recruiting

  • Kantonsspital Winterthur

    Winterthur,
    Switzerland

    Active - Recruiting

  • Universitätsspital Zürich

    Zürich,
    Switzerland

    Site Not Available

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