Clinical trial NCT05681988: Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)
Official title: Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracerebral Haemorrhage
Keywords: spontaneous supratentorial intracerebral haemorrhage (SSICH)
best medical treatment (BMT)
surgical hematoma evacuation
conventional craniotomy (CC)
early image-guided endoscopic surgery
endoscopic surgery (ES)
minimally invasive surgery (MIS)
minimally invasive puncture surgery (MIPS)
stereotactic aspiration (SA)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: University Hospital, Geneva
name: Cantonal Hospital of St. Gallen
name: Ospedale Regionale di Lugano
name: Centre Hospitalier Universitaire Vaudois
name: Hôpital du Valais
name: University Hospital, Zürich
name: Kantonsspital Winterthur KSW
name: Insel Gruppe AG, University Hospital Bern
name: Luzerner Kantonsspital
First posted: 2023-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: National multi-centre, two-arm, open labelled randomised controlled trial within the stroke units and stroke centres of the swiss stroke registry in a superiority fashion.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Good functional outcome, measured by the modified Rankin Scale (mRS)
timeFrame: At 6 months after treatment
Secondary outcomes:
measure: Mortality rate
timeFrame: At 6 and 12 months after intervention
measure: Change in Quality of Life, assessed by Patient-Reported Outcomes Measurement Information System (PROMIS®) questionnaire
timeFrame: At 3 and 6 months after intervention
measure: Change in Patient cognitive outcome as assessed by the Montreal-Cognitive-Assessment-Test (MOCA® )
timeFrame: At 3 and 6 months after intervention
measure: Morbidity rate
timeFrame: At 6 and 12 months after intervention
measure: Change of focal neurological deficit measured by the National Institute of Health Stroke Scale (NIHSS)
timeFrame: From baseline to 6 months after intervention
measure: Time to intervention
timeFrame: At baseline
measure: Total time spent on the intensive care unit (ICU)/stroke unit
timeFrame: At 7 days/discharge after intervention
measure: Total time spent in intubation measured in minutes
timeFrame: At 7 days/discharge after intervention
measure: Proportion of hematoma volume reduction rate (in the intervention group only)
timeFrame: Directly after intervention
measure: Change in Patient Satisfaction Questionnaire
timeFrame: At 3 and 6 months after intervention
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Neurosurgery, University Hospital Basel
city: Bern
country: Switzerland
facility: University Hospital Bern
city: Geneva
country: Switzerland
facility: Hopitaux Universitare Geneve
city: Lausanne
country: Switzerland
facility: Centre Hopitalier Universitaire Vaudoise
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Sion
country: Switzerland
facility: Centre Hopitalier Universitaire du Valais Romand
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Department of Neurosurgery, University Hospital Basel
name: Jehuda Soleman, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hallenberger TJ, Guzman R, Soleman J. Minimally invasive image-guided endoscopic evacuation of intracerebral haemorrhage: How I Do it. Acta Neurochir (Wien). 2023 Jun;165(6):1597-1602. doi: 10.1007/s00701-022-05326-3. Epub 2022 Aug 5.