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New treatment option for Intracerebral Haemorrhage
Official title Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)
ClinicalTrials.gov ID: NCT05681988
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Spontaneous supratentorial intracerebral hemorrhage (SSICH), defined as the sudden occurrence of bleeding into the lobar parenchyma and/or into the...
- 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)
You likely can't join if
- SSICH due to known or suspected structural abnormality in the brain (e.g. vascular malformation, aneurysm, arteriovenous malformation (AVM), brain...
- 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...
- Pregnancy
- Relevant disability prior to SSICH (mRS \>2)
See the full eligibility 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...
- 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)
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
- Bern, Switzerland
- Geneva, Switzerland
- Lausanne, Switzerland
- Lucerne, Switzerland
- Lugano, Switzerland
- Sankt Gallen, Switzerland
- Sion, Switzerland
- Winterthur, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland; Bern, Switzerland; Geneva, Switzerland; Lausanne, Switzerland; Lucerne, Switzerland; Lugano, Switzerland and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.