Intracerebral hemorrhage
Conditions
Interventions
Patients will be randomized (1:1) to minimally invasive endoscopy-guided surgery performed within 8 hours of symptom onset in addition to standard medical management or to standard medical management
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older; 2. NIHSS = 2; 3. Supratentorial non-traumatic ICH confirmed by non-contrast CT, without a CTA confirmed causative vascular lesion (e.g. aneurysm, AVM, DAVF, 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
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; 7. DIST-INFLAME (sub-study): patients that use immunosuppressive or immune-modulating medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter will be the modified Rankin scale (mRS) score at 180 days. This categorical scale measures functional outcome with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect will be estimated with ordinal logistic regression analysis as common odds ratio, adjusted for neurosurgical center and prespecified prognostic factors. The adjusted common odds ratio will measure the likelihood that minimally invasive endoscopy-guided surgery will lead to lower mRS scores as compared to standard medical management alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include: the score on the mRS at 90 and 365 days; good outcome (defined as a mRS 0-2), favorable outcome (mRS 0-3) and all other possible dichotomizations of the mRS at 90, 180 and 365 days; NIHSS at day 6 (±1 day); death, Barthel Index, EuroQol-5D-5L, SS-QOL, health economic evaluations (medical consumption, productivity loss and burden for the caregiver), patient location and home time at 90, 180 and 365 days. Safety outcomes will be death within 24 hours, at 7 and at 30 days and procedure-related complications within 7 days. Technical efficacy outcomes will be percentage volume reduction based on the baseline CT and CT at 24 hours (± 6 hours), percentage of participants with clot volume reduction =70%, and =80%, and with remaining clot volume =10mL, and =15mL, and conversion to craniotomy. In DIST-INFLAME, outcomes will include perihematomal edema at 6 days (±1 day), functional outcome at 180 days and immune and metabolomic profiles at 3 (± 12 hours) and 6 days (±1 day). | — |
Countries
Austria, Belgium, Denmark, Germany, Netherlands, Spain
Contacts
Public ContactC.J.M. Klijn
Radboud Universitair Medisch Centrum
Outcome results
None listed