Condition: Intracerebral Hemorrhage · Minimally Invasive Surgical Procedures · Endoscopic Surgical Procedures · Sponsor: Radboud University Medical Center
Background: Intracerebral hemorrhage (ICH) accounts for 16-19% of all strokes in Western Europe and contributes profoundly to mortality and disability. Thirty-day case fatality is 40% and of those surviving, only few gain independence. Except for stroke unit care and possibly early blood pressure lowering, there is currently no treatment of proven benefit. Surgical treatment has so far not been proven effective. In the largest trials STICH I and II, and MISTIE III, the median time to treatment was more than 24 hours, which may be an important explanation for the lack of a treatment effect. A recent meta-analysis of randomized controlled trials showed that surgical treatment may be beneficial, in particular with minimally invasive procedures and when performed early. In the Dutch ICH Surgery pilot study, we showed that early minimally invasive endoscopy-guided surgical treatment performed within 8 hours of symptom onset in patients with supratentorial ICH is safe and technically effective. We hypothesize that early minimally invasive endoscopy-guided surgery improves the outcome in patients with supratentorial spontaneous ICH. Objectives: 1. To study whether minimally invasive endoscopy-guided surgery, in addition to standard medical management, for the treatment of spontaneous supratentorial ICH performed within 8 hours of symptom onset, improves functional outcome in comparison with standard medical management alone; 2. Determine whether patients treated with minimally inv…
This description comes directly from the study's public registry record.
Catharina JM Klijn, MD PhD · +31 24 361 33 94 · karin.klijn@radboudumc.nl
Floor NH Wilting, MD · +31 24 36166 00 · floor.wilting@radboudumc.nl
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| 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 |
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Source record: clinicaltrials.gov/study/NCT05460793