Dutch Intracerebral Hemorrhage Surgery Trial

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jul 12, 2022

Keywords

ClinConnect Summary

The Dutch Intracerebral Hemorrhage Surgery Trial is studying whether a specific type of surgery, called minimally invasive endoscopy-guided surgery, can help patients who have had a type of stroke known as intracerebral hemorrhage (ICH). This surgery would be performed within 8 hours of the stroke's onset, alongside standard medical care. The goal is to see if this approach leads to better recovery outcomes than just medical treatment alone. Researchers will look at improvements in daily functioning after 180 days and also assess any potential side effects from the surgery.

To participate in the trial, individuals must be at least 18 years old and have a confirmed diagnosis of spontaneous supratentorial ICH, with certain conditions related to the size of the bleed and their overall health. Patients will be randomly assigned to either receive the surgery along with standard care or only standard care. Throughout the study, participants will have regular check-ups to monitor their progress, and researchers will also analyze blood samples to understand how the body responds to the treatment. This trial aims to provide valuable information on the effectiveness and safety of this surgical approach for ICH patients.

Gender

ALL

Eligibility 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.