Risk Stratification and Minimally Invasive Surgery in Acute ICH Patients
Risk Stratification and Minimally Invasive Surgery in Acute ICH Patients
The study consists of 2 parts: the first part is to conduct a multicenter retrospective
 analysis of more than 1000 acute ICH patients treated by conservative observation from 33
 centers in China to create a predictive model of intracerebral hemorrhage growth based on
 clinical, blood, genetic, imaging, and pharmacological factors; the second part is to
 validate the efficacy of the minimally invasive surgery, including stereotactic thrombolysis
 and endoscopic surgery, in 300 eligible patients with high risk of hemorrhage growth
 according to the first part results in a prospective multicenter cohort study.
Spontaneous intracerebral hemorrhage (ICH) accounts for 2 million strokes worldwide per year
 and is the deadliest subtype of stroke with a 1-year mortality rate up to 50%. Given the high
 morbidity and mortality of this disease process, surgical options have been repeatedly
 evaluated in large multicenter randomized controlled trials that unfortunately have not
 demonstrated improved outcomes. Time to treatment is a factor that has been shown to carry
 enormous weight in the treatment of ischemic stroke but has not yet been demonstrated to play
 a role in hemorrhagic stroke. On the other hand, Intracerebral hemorrhage growth in
 early-stage is associated with the poor clinical outcome. Thus, investigators assume that
 minimally invasive surgery in early-stage ICH patients with high risk of hemorrhage growth
 may improve the long-term outcomes. In the first part, the investigators will review more
 than 1000 early-stage ICH patients from 33 centers within the last 5 years in China to create
 a predictive model of intracerebral hemorrhage growth based on clinical, blood, genetic,
 imaging, and pharmacological factors. The "early-stage" means 24 hours from symptom onset to
 baseline imaging. The "hemorrhage growth" is defined as an increase in intracerebral
 hemorrhage volume between baseline and repeat imaging of more than 6 mL or more than 33%. The
 second part is to validate the efficacy of the minimally invasive surgery in patients with
 high risk of hemorrhage growth according to the first part results in a prospective
 multicenter cohort study. Endoscopic surgery and stereotactic thrombolysis (150 patients)
 will be compared with conventional treatment (150 patients), including medical treatment and
 conventional craniotomy. Clinical data and laboratory data will be collected by electric case
 report form (CRF) and uploaded online by each neurosurgery center to form the prospective
 clinical database in First Affiliated Hospital of Fujian Medical University. This cohort
 follow-up study will be across a 3-year period with a 2 years interval of enrollment and 1
 year follow up for each patient.
1. Retrospective part

 Inclusion Criteria:

 -  Emergent CT showed a spontaneous supratentorial intracerebral hemorrhage (patient
 with a small amount of intraventricular hemorrhage is eligible);

 -  Patients should have undergone baseline CT scan within 24 hours after hemorrhage
 onset and repeated fewer than 48 hours;

 -  Patients without herniation.

 -  Patients were treated by observation before hemorrhage growth (if happened).

 Exclusion Criteria:

 -  Spontaneous intracerebral hemorrhage secondary to an underlying structural cause
 identified by brain imaging, (ie, vascular malformation, aneurysm, tumor);

 -  The time from symptom onset to baseline imaging was not known in hours, clinical
 information or lab results was not enough to determine the growth of the hematoma
 or to perform statistical analysis;

 -  Patients had accepted acute treatment that might have reduced intracerebral
 hemorrhage volume (ie, surgical evacuation, external ventricular drainage, lumbar
 puncture).

 2. Prospective part

 Inclusion Criteria:

 -  Emergent CT showed a spontaneous supratentorial intracerebral hemorrhage (patient with
 a small amount of intraventricular hemorrhage is eligible);

 -  Patients without herniation meet the clinical uncertainty principle as follows: the
 responsible neurosurgeon is uncertain about the benefits of surgery.

 -  Patients should have undergone baseline CT scan within 24 hours after hemorrhage
 onset; the volume of the hematoma is more than 20 ml and less than 100ml on the first
 CT scan.

 -  Patients with a Glasgow coma score of 5 or more.

 -  Informed consent, and willing to accept long-term follow-up.

 Exclusion Criteria:

 -  Spontaneous intracerebral hemorrhage secondary to an underlying structural cause
 identified by brain imaging, (ie, vascular malformation, aneurysm, tumor);

 -  patients had a cerebellar hemorrhage or extension of a supratentorial hemorrhage into
 the brainstem;

 -  patients had severe pre-existing physical or mental disability or severe comorbidity
 that might interfere with the assessment of outcome.

 -  Severe coagulopathy, INR cannot be reversed to less than or equal to 1.5

 -  Patients during pregnancy or lactation.