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โ† Trials
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Dutch Intracerebral Hemorrhage Surgery Trial

RecruitingNAAges 18 Years - anyAllRadboud University Medical Center
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 18 years or older; 2. NIHSS โ‰ฅ 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 โ‰ฅ3; 2. ICH-GS score โ‰ฅ11; 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.
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What it tests

  • Minimally invasive endoscopy-guided surgery
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Where

11 sites
Amsterdam University Medical Center
Amsterdam, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Haaglanden Medical Center
The Hague, Netherlands

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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