Swiss trial of decompressive craniectomy versus best medical treatment of spontaneous supratentorial intracerebral hemorrhage: a randomized controlled trial

Recruiting

Conditions: spontaneous intracerebral hemorrhage / brain bleeding
10007963
10009720
10047075

Registration Number: NL-OMON50259

Lead Sponsor: Inselspital, universitätsspital Bern

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

- Age: >=18 to <=75 years
- Deep ICH (basal ganglia or thalamus) that may extend into cerebral lobes,
ventricles or subarachnoid space
- Acute stroke syndrome due to a spontaneous ICH
- NIHSS score of >=10 and <=30
- Glasgow coma scale (GCS) >7 and <14
- Randomization within 66 hours after ictus
- Surgical treatment not later than 6 hours after randomization
- Volume of hematoma >=30 ml and <=100 ml

Exclusion Criteria

- ICH due to known or suspected structural abnormality in the brain (e.g.,
intracranial aneurysm, brain arteriovenous malformation, brain tumor) or brain
trauma, or previous stroke thrombolysis
- Cerebellar or brainstem hemorrhage
- Exclusive lobar hemorrhage
- Moribund patients (GCS 3-7)
- Patient has a signed do-not-treat statement
- Known advanced dementia or significant pre-stroke disability
- Concomitant medical illness that would interfere with outcome assessment and
follow-up
- Pregnancy
- Prior major brain surgery within <6 month or prior DC
- Foreseeable difficulties in follow-up due to geographic reasons
- Known definite contraindication for a surgical procedure
- A very high likelihood that the patient will die within the next 24 hours on
the basis of clinical and/or radiological criteria
- Previous participation in this trial or in another ongoing investigational
trial
- Prior symptomatic ICH
- ICH secondary to thrombolysis
- Bilateral areactive pupils

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> Primary outcome is the composite of mortality or dependency (mRS score 5<br /><br>[severe dependency] or 6 [death]) at 180 days ± 14 days. Primary endpoint (mRS)<br /><br>will be assessed by a structured telephone interview (180 days ± 14 days post<br /><br>randomization)</p><br>

Secondary Outcome Measures