Chongqing Intracerebral Hemorrhage Study

Stroke Clinical Trial

Official title:

Chongqing Intracerebral Hemorrhage Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03085472
• Other study ID #: X1517
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2017
• Last updated: March 15, 2017
• Start date: February 16, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2017
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Qi Li, MD;PhD
• Phone: 86 18523381983
• Email: qili_md[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2023
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hematoma
• Hemorrhage
• Intracerebral Hemorrhage
• Stroke

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

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