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

Recruiting

Conditions: Intracerebral hemorrhage
Intracerebral hematoma
10007963
10009720

Registration Number: NL-OMON51777

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 600

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter will be the modified Rankin scale (mRS) score at<br /><br>180 days. This categorical scale measures functional outcome with scores<br /><br>ranging from 0 (no symptoms) to 6 (death). The treatment effect will be<br /><br>estimated with ordinal logistic regression analysis as common odds ratio,<br /><br>adjusted for prespecified prognostic factors. The adjusted common odds ratio<br /><br>will measure the likelihood that minimally invasive endoscopy-guided surgery<br /><br>will lead to lower mRS scores as compared to standard medical management alone.</p><br>

Secondary Outcome Measures