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Collaborators 

Dear Collaborators, Here you can find the most important facts of the EMINENT-ICH trial for a quick reference. Furthermore, you can access the most important study documents for further informations and for download.

background

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 remain ambiguous and consist of either the current gold standard, best medical treatment, 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. We therefore propose a minimal invasive approach with early image-guided endoscopic surgery conducted within 24 hours. Endoscopic surgery was shown to be safe and effective, however large trials analyzing the benefits of endoscopic surgery are lacking. We therefore hypothesize, that an earlier, more complete and more rapid hematoma evacuation will improve the functional outcome and mortality rates in these patients. 

Design

This is a multi-centre, two-arm, open-labelled randomised controlled trial in superiority fashion.

Objectives and outcomes

The primary objective is to show superiority of early minimally invasive image-guided hematoma evacuation additionally to BMT compared to BMT alone in functional outcome rates at 6 months in patients with SSICH.

 

Secondary objectives are

  • to show superior survival rates of patients in the ES arm

  • to study patient reported quality of life after treatment for SSICH at different time points (3 and 6 months after intervention)

  • to study patient satisfaction with the outcome after treatment for SSICH at different time points (3 months and 6 months after intervention)

  • to study cognitive outcome in patients after treatment for SSICH at different time points (3 months and 6 months after intervention)

  • to study the morbidity rates of patients in both treatment arms

  • to study the efficacy of ES in reducing the hematoma volume

  • to study the change in focal neurological deficits exhibited by the patients after treatment. 

  • to study the temporal evolution of serum biomarkers (Neurofilament light-chain subunit (NfL), Glial Fibrillary Acidic Protein (GFAP), S100 calcium-binding protein B (S100), IL-2, IL-4, IL-6, IL-8, IL-10 and TNF-α) and their change in relation to early hematoma ES.

 

Primary outcome

  • Good functional outcome 6 months after treatment, measured by the mRS. Good functional outcome is defined as a mRS of ≤3 points and will be assessed as binary outcome at 6 months after treatment.

 

Secondary outcomes

  • The mortality rate as measured by death of a participant at 6 months after intervention.

  • Patient reported outcome measures at 3 and 6 months after intervention, those being:

    • Patient and caregiver quality of life as assessed by the PROMIS® questionnaire

    • Patient Satisfaction as assessed by a short survey on a scale of 1-5 

    • Patient cognitive outcome as assessed by the MOCA® Test

  • The morbidity rate, meaning occurrence of:

    • Ischemic stroke 

    • Recurrent SSICH (defined as any radiologically confirmed increase in hematoma volume postoperative/follow-up that is either asymptomatic or associated with a worsening of the focal-neurological deficit by ≥4 points on the NIHSS and/or a decrease in consciousness by ≥2 points on the GCS)

    • Epileptic seizure

    • Surgical site infection (intervention group only)

    • Any need for open neurosurgical procedures

    • Infections (i.e. pneumonia, urinary tract infection)

    • Any other not defined complication that prolongs the hospital stay and/or leads to further treatment not envisaged in the original treatment plan.

  • The change of focal neurological deficit measured by the NIHSS, from baseline to 6 months after intervention as a continuous variable

  • The time to intervention, defined as the period from symptom onset/last seen well to start of surgery (start surgical measures, i.e. positioning of patient) or start of medical treatment (admission of first treatment of BMT)

  • The temporal evolution of serum levels of the prespecified biomarkers as continuous variable from start to 6 months after intervention

  • The total time spent on the intensive care unit (ICU)/stroke unit as a continuous variable from the first admission to the ICU/stroke unit to discharge from ICU/stroke unit at 7 days/discharge after intervention

  • The total time spent in intubation measured in minutes from the start of intubation to extubation as specified in the anesthesiology report at 7 days/discharge after intervention

 

Outcomes/Measurements applying to the intervention group only

  • The proportion of hematoma volume reduction rate (goal ≤15% of its initial volume). The hematoma volume reduction rate will be a binary variable

  • The relative (percentage) reduction or increase of hematoma volume from baseline admission cCT to postoperative cCT directly after surgery as a continuous variable (final value).

Eligibility 

Inclusion criteria

  • Patient age ≥ 18 and <85

  • 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 (measured using the formula )

  • Stable clot volume defined as absence of increase of >33% (as assessed using the formula (A * B * C)/2) of initial clot volume on follow-up imaging.

  • 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 (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 (only for patients able to consent)

 

Exclusion criteria 

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

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

  • Infratentorial hemorrhage or midbrain extension/involvement of the hemorrhage

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

  • Positive history of current pregnancy, breast-feeding, or positive pregnancy test [either serum or urine] in premenopausal women

  • 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)

Study centres

If you are interested to participate as a collaborator, please check the following eligibility criteria for your centre.

  • Must have a stroke unit or be certified as stroke centre

  • Must have neurosurgical OR with endoscope and some form of neuronavigation

  • Must be able to conduct directly postoperative CT for assessment of hematoma evacuation rate

  • Must have 24-hour neurosurgical and neurological service

Visit schedule

Here you will find the visit schedule for
the EMINENT-ICH trial

click to see the whole schedule

Visit Schedule

number of patients NEEDED

200

number of patients included

003

Downloads

EMINENT Protocol V2.0.pdf

SOP EMINENT-ICH RCT 001_informing-and-consenting_3.0.2

SOP EMINENT-ICH RCT 002_reporting-of-serious-adverse-events_2.3.0

SOP EMINENT-ICH RCT 003_blood-sample-handling-and-storage_1.0.0

SOP EMINENT-ICH RCT 004_sop-minimal-invasive-image-guided-endoscopic-surgery

SOP EMINENT-ICH 005_sop-eminent-ich-005-outcome-assessment-via-telephone-interv

SAE Poster EMINENT

secutrial LOGIN

Please log-in to secuTrial here: https://secutrial.dkfbasel.ch

Videos

You will find our instructional videos here:

Randomization

CRF

ICF Procedure

EMINENT Surgery technique 

SITE Trainings

06.02.2024

Ospedale Regionale di Lugano

12.02.2024

Universitätsspital Zürich

29.02.2024

Kantonsspital Luzern

18.03.2024

Kantonsspital St.Gallen

11.04.2024

Inselspital Bern

18.04.2024
Hôpitaux universitaires de Genève

13.05.2024

Kantonsspital Graubünden Chur

16.05.2024

Klinik Hirslanden Zürich

13.06.2024

Centre Hospitalier Universitaire Vaudois Lausanne

09.07.2024

Hôpital du Valais Sion

Please visit
ClinicalTrials.gov
To get an overview
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