The Dutch ICH Surgery Trial pilot study; minimally-invasive endoscopy-guided surgery for spontaneous intracerebral hemorrhage

Completed

Conditions: 10007963
Brain haemorrhage
Intracerebral hematoma
10009720

Registration Number: NL-OMON46374

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

1. Age * 18
2. NIHSS * 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. Written informed consent

Exclusion Criteria

1. Pre-stroke disability, which interferes with the assessment of functional outcome at 90 days, i.e. mRS > 2
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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome parameters will be safety (death within 24 hours; 7-day<br /><br>procedure related complications; 7-day mortality, 30 day mortality) and<br /><br>technical effectiveness (proportional volume reduction; proportion of patients<br /><br>with clot volume reduction 60% and 80%; proportion of patients with remaining<br /><br>clot volume *15mL). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters will be the effect of surgery on 90 day functional outcome<br /><br>(modified Rankin Scale) in comparison with the matched control patients with<br /><br>ICH, on NIHSS at one week and on functional outcome after 180 days.</p><br>