Chongqing Intracerebral Hemorrhage Study

March 15, 2017 updated by: Qi Li, First Affiliated Hospital of Chongqing Medical University

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Chongqing, China, 400016
    - Recruiting
    - The First Affiliated Hospital of Chongqing Medical University
    - Contact:
      
      Qi Li, MD;PhD
      
      Phone Number: +(86) 18523381983
      
      Email: qili_md@126.com
    - Principal Investigator:
      
      Qi Li, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

18 Years and older (Adult patients)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
benigh hematoma Patients with novel imaging markers or clinical features suggestive of a relatively benigh hematoma (less likely to expand and have a relatively good outcome).
malignant hematoma Patients with novel imaging markers or clinical features suggestive of a relatively bad hematoma (more likely to expand and have a relatively poor outcome).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hematoma volume growth at 24 hours Time Frame: 24 hours	To assess early hematoma volume growth at 24 hours	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 16, 2017

Primary Completion (ANTICIPATED)

February 1, 2019

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (ACTUAL)

March 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)