Clinical trial NCT03085472: Chongqing Intracerebral Hemorrhage Study
Official title: Chongqing Intracerebral Hemorrhage Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracerebral Hemorrhage
Stroke
Hematoma
Keywords: intracerebral hemrrohage
stroke
China
hematoma
CT
predictor
prognosis
outcome
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 Years and older (Adult patients)

Brief summary: The Chongqing intracerebral hemorrhage study is a multi-center, prospective, observational study led by professor Qi Li from Chongqing Medical University. Professor Peng Xie will be the senior consultant for the study. The Chongqing intracerebral hemorrhage study will focus on the epidemiology, natural history, pathogenesis, laboratory, radiological aspects, clinical outcomes and the effects of treatment in patients with intracerebral hemorrhage.

The clinical, laboratory, imaging, genetic and outcome data of patients diagnosed with acute intracerebral hemorrhage will be prospectively collected. The prognosis of patients with intracerebral hemorrhage will be assessed by using several outcome measure scales at different time points.

Detailed description: The Chongqing intracerebral hemorrhage study will try to address several key issues in ICH. The baseline clinical data including demographic, disease severity scores, prior drug history and relevant medical history, premorbid mRS scores will be prospectively recorded. The admission and follow-up imaging data of all registered patients will be saved as Dicom format for future use and review. The functional outcomes will be assessed and recorded by experienced neurologists.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Informed consent to participate in the study
* Patients diagnosed with CT-confirmed spontaneous Intracerebral Hemorrhage (ICH)
* Patients are willing to participate in the follow up assessment

Exclusion Criteria:

* Did not agree to participate in the study
* Secondary ICH to hemorrhagic infarction or tumor bleeding etc.
* Traumatic ICH

Primary outcomes:
measure: hematoma volume growth at 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: functional outcome at 3 months assessed by modified Ranking Scale
timeFrame: 3 months
measure: early neurological deterioration assessed by NIHSS score at 24 hours
timeFrame: 24 hours
measure: early neurological deterioration assessed by NIHSS at 48 hours
timeFrame: 48 hours
measure: early neurological deterioration assessed by NIHSS score
timeFrame: 72hours
measure: perihematoma edema volume measurement at 24 hours
timeFrame: 24 hours
measure: perihematoma edema volume measurement at 72 hours
timeFrame: 72 hours
measure: intraventricular hemorrhage growth
timeFrame: 24 hours
measure: major thromboembolic events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
References: