Intracerebral hemorrhage (intracerebrale bloeding) Minimally invasive surgery (minimaal invasieve chirurgie)
Conditions
Interventions
Minimally-invasive endoscopy-guided surgery within 8 hours after symptom onset, additional to standard medical management.
Minimaal invasieve endoscopie geleide chirurgie binnen 8 uur na het starten
Sponsors
Radboud University Medical Center
(on behalf of the CONTRAST consortium)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age ≥ 18 2. NIHSS ≥ 2 (Table 2) 3. Supratentorial ICH confirmed by CT, without a CTA confirmed causative vascular lesion (eg aneurysma, AVM, DAVF, CVST). 4. Minimal lesion size 10 mL 5. Intervention can be started within 8 hours from symptoms onset; or for controls presentation within 8 hours of symptom onset. 6. Patient¡es or legal representative's written informed consent
Exclusion criteria
Exclusion criteria: 1. Pre-stroke disability, which interferes with the assessment of functional outcome at 90 days, i.e. mRS > 2 (Table 1) 2. Causative vascular lesion (e.g. aneurysm, AVM, DAVF, CVST) on CTA or other known underlying cause (e.g. tumor, cavernoma) 3. Untreated coagulation abnormalities, including INR > 1.3 (point of care measurement allowed) and treatment with oral thrombin or factor X antagonists; patients on vitamin K antagonist can be included after correction of the INR. 4. Current known severe infection for which antibiotic treatment at time of ICH symptom onset 5. Patient moribund (eg. coning, bilateral dilated unresponsive pupils) 6. Pregnancy (note: most patients will be beyond child bearing age; if not a pregnancy test is mandatory).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters will be the effect of surgery on the 90-day and 180-day functional outcome, compared with the controls, measured by the modified Rankin Scale score. Secundaire uitkomstparameters zijn het effect van de chirurgische behandeling op de NIHSS na een week en functioneren na 90 en 180 dagen, gemeten met de gemodificeerde Rankin Scale, vergeleken met de controle patiënten. | — |
Primary
| Measure | Time frame |
|---|---|
| The main outcome parameters will be safety (death within 24 hours; 7-day procedure related complications; 7-day mortality; 30-day mortality) and technical effectiveness (proportional volume reduction, proportion of patients with clot volume reduction >60% and >80%, proportion of patients with remaining clot volume <15mL) De primaire uitkomstparameters zijn veiligheid (overlijden binnen 24 uur; procedure gerelateerde complicaties binnen 7 dagen; mortaliteit binnen 7 en 30 dagen) en technische effectiviteit (volume reductie; het aantal patient met een volumereductie van ≥60% en ≥80%; het aantal patiënten met een residu bloedvolume van minder dan 15 mL). | — |
Contacts
Public ContactC.J.M. Klijn
University Medical Center Utrecht Brain Center Rudolf Magnus Department of Neurology & Neurosurgery G03.232 PO Box 85500
Outcome results
None listed