Phase
Condition
Hemorrhage
Brain Injury
Stroke
Treatment
Minimally invasive endoscopy-guided surgery
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 years or older;
NIHSS ≥ 2;
Supratentorial non-traumatic ICH confirmed by non-contrast CT, without aCT-angiography confirmed causative vascular lesion (e.g. aneurysm, arteriovenousmalformation [AVM], dural arteriovenous fistula [DAVF], cerebral venous sinusthrombosis [CVST]), or other known underlying lesion (e.g. tumor, cavernoma);
Minimal hematoma volume of 10 mL;
Intervention can be started within 8 hours of symptom onset;
Written informed consent (deferred).
Exclusion
Exclusion Criteria:
Considerable pre-stroke dependency in activities of daily living, defined as apre-stroke mRS ≥3;
ICH-GS score ≥11;
Hemorrhage due to hemorrhagic transformation of an infarct;
Untreated coagulation abnormalities, including INR >1.3 (point of caremeasurement allowed), treatment with heparin and treatment with factor Xainhibitors. Patients on vitamin K antagonist can be included after correction of theINR, and patients on dabigatran (direct thrombin inhibitor) can be included afterreversal of dabigatran with idarucizumab;
Moribund (e.g. coning, bilateral dilated unresponsive pupils), or progressivelydeteriorating clinical course with imminent death;
Pregnancy (note: most patients will be beyond childbearing age);
DIST-INFLAME sub-study: patients that use immunosuppressive or immune-modulatingmedication.
Study Design
Study Description
Connect with a study center
Amsterdam University Medical Center
Amsterdam,
NetherlandsActive - Recruiting
Medisch Spectrum Twente
Enschede,
NetherlandsSite Not Available
University Medical Center Groningen
Groningen,
NetherlandsSite Not Available
Leiden University Medical Center
Leiden,
NetherlandsSite Not Available
Maastricht University Medical Center
Maastricht,
NetherlandsActive - Recruiting
Radboud University Medical Center
Nijmegen,
NetherlandsActive - Recruiting
Erasmus University Medical Center
Rotterdam,
NetherlandsActive - Recruiting
Haaglanden Medical Center
The Hague,
NetherlandsActive - Recruiting
Elisabeth-TweeSteden Hospital
Tilburg,
NetherlandsActive - Recruiting
University Medical Center Utrecht
Utrecht,
NetherlandsActive - Recruiting
Isala
Zwolle,
NetherlandsActive - Recruiting
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