Chongqing Intracerebral Hemorrhage Study

• Conditions: Stroke; Intracerebral Hemorrhage; Hematoma

• Registration Number: NCT03085472
• Lead Sponsor: First Affiliated Hospital of Chongqing Medical University

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.

Study Timeline

• Study Start: 2017-02-16
• Status Verified: 2017-03
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-15
• Last Update Submitted: 2017-03-15
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21
• Primary Completion: 2019-02-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hematoma volume growth at 24 hours	24 hours	To assess early hematoma volume growth at 24 hours

Secondary Outcome Measures

Name	Time	Method
functional outcome at 3 months assessed by modified Ranking Scale	3 months	assess functional outcome at 3months using mRS
early neurological deterioration assessed by NIHSS at 48 hours	48 hours	To assess early neurological deterioration using NIHSS score at 48 hours
early neurological deterioration assessed by NIHSS score	72hours	To assess early neurological deterioration using NIHSS score at 72 hours
perihematoma edema volume measurement at 24 hours	24 hours	to measure the perihematoma edema volume at 24 hours
perihematoma edema volume measurement at 72 hours	72 hours	to measure the perihematoma edema volume at 72 hours
intraventricular hemorrhage growth	24 hours	to assess the presence of IVH at 24 hours
major thromboembolic events	2 weeks	to assess the thromboembolic events 2 weeks after admission
early neurological deterioration assessed by NIHSS score at 24 hours	24 hours	To assess early neurological deterioration using NIHSS score at 24 hours

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China