Minimally invasive surgery for intracerebral hemorrhage
Dutch ICH Surgery Trial; Minimally Invasive Endoscopy-guided Surgery for Spontaneous Supratentorial Intracerebral Hemorrhage
This study is testing if early minimally invasive surgery can help people with brain bleeding feel better when done within 8 hours of their symptoms starting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Drugs / interventions | idarucizumab |
| Locations | 11 sites (Amsterdam and 10 other locations) |
| Trial ID | NCT05460793 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of supratentorial non-traumatic ICH and a hematoma volume of at least 10 mL.
Not a fit: Patients with considerable pre-stroke dependency or those with certain coagulation abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality and improve recovery outcomes for patients with intracerebral hemorrhage.
How similar studies have performed: Previous studies have suggested that early surgical intervention for ICH may be beneficial, indicating that this approach could build on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amsterdam and 10 other locations
- Amsterdam University Medical Center — Amsterdam, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Netherlands (Not_yet_recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Not_yet_recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Not_yet_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)
- University Medical Center Utrecht — Utrecht, Netherlands (Recruiting)
- Isala — Zwolle, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.