Minimally invasive surgery for intracerebral hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of early minimally invasive endoscopy-guided surgical treatment for patients suffering from supratentorial intracerebral hemorrhage (ICH). The study aims to initiate surgical intervention within 8 hours of symptom onset to potentially improve outcomes, as previous trials have shown delayed treatment may hinder effectiveness. Participants will be closely monitored to assess safety and technical efficacy of the procedure. The trial is conducted across multiple prominent medical centers in the Netherlands.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older;
2. NIHSS ≥ 2;
3. Supratentorial non-traumatic ICH confirmed by non-contrast CT, without a CT-angiography confirmed causative vascular lesion (e.g. aneurysm, arteriovenous malformation \[AVM\], dural arteriovenous fistula \[DAVF\], cerebral venous sinus thrombosis \[CVST\]), or other known underlying lesion (e.g. tumor, cavernoma);
4. Minimal hematoma volume of 10 mL;
5. Intervention can be started within 8 hours of symptom onset;
6. Written informed consent (deferred).

Exclusion Criteria:

1. Considerable pre-stroke dependency in activities of daily living, defined as a pre-stroke mRS ≥3;
2. ICH-GS score ≥11;
3. Hemorrhage due to hemorrhagic transformation of an infarct;
4. Untreated coagulation abnormalities, including INR \>1.3 (point of care measurement allowed), treatment with heparin and treatment with factor Xa inhibitors. Patients on vitamin K antagonist can be included after correction of the INR, and patients on dabigatran (direct thrombin inhibitor) can be included after reversal of dabigatran with idarucizumab;
5. Moribund (e.g. coning, bilateral dilated unresponsive pupils), or progressively deteriorating clinical course with imminent death;
6. Pregnancy (note: most patients will be beyond childbearing age);
7. DIST-INFLAME sub-study: patients that use immunosuppressive or immune-modulating medication.

Where it's running

• Amsterdam University Medical Center
  Amsterdam, Netherlands Recruiting
• Maastricht University Medical Center
  Maastricht, Netherlands Recruiting
• Radboud University Medical Center
  Nijmegen, Netherlands Recruiting
• Erasmus University Medical Center
  Rotterdam, Netherlands Recruiting
• Haaglanden Medical Center
  The Hague, Netherlands Recruiting
• Elisabeth-TweeSteden Hospital
  Tilburg, Netherlands Recruiting

Study contacts

• Principal investigator: Catharina JM Klijn, MD PhD — Radboud University Medical Center
• Study coordinator: Catharina JM Klijn, MD PhD
• Email: karin.klijn@radboudumc.nl
• Phone: +31 24 361 33 94

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.