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Chongqing Intracerebral Hemorrhage Study

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ClinicalTrials.gov Identifier: NCT03085472
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Qi Li, 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.


Condition or disease
Intracerebral Hemorrhage Stroke Hematoma

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
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chongqing Intracerebral Hemorrhage Study
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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).



Primary Outcome Measures :
  1. hematoma volume growth at 24 hours [ Time Frame: 24 hours ]
    To assess early hematoma volume growth at 24 hours


Secondary Outcome Measures :
  1. functional outcome at 3 months assessed by modified Ranking Scale [ Time Frame: 3 months ]
    assess functional outcome at 3months using mRS

  2. 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

  3. early neurological deterioration assessed by NIHSS at 48 hours [ Time Frame: 48 hours ]
    To assess early neurological deterioration using NIHSS score at 48 hours

  4. early neurological deterioration assessed by NIHSS score [ Time Frame: 72hours ]
    To assess early neurological deterioration using NIHSS score at 72 hours

  5. perihematoma edema volume measurement at 24 hours [ Time Frame: 24 hours ]
    to measure the perihematoma edema volume at 24 hours

  6. perihematoma edema volume measurement at 72 hours [ Time Frame: 72 hours ]
    to measure the perihematoma edema volume at 72 hours

  7. intraventricular hemorrhage growth [ Time Frame: 24 hours ]
    to assess the presence of IVH at 24 hours

  8. major thromboembolic events [ Time Frame: 2 weeks ]
    to assess the thromboembolic events 2 weeks after admission



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
18 Years and older (Adult patients)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085472


Contacts
Contact: Qi Li, MD;PhD 86 18523381983 qili_md@126.com

Locations
China
The First Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, China, 400016
Contact: Qi Li, MD;PhD    +(86) 18523381983    qili_md@126.com   
Principal Investigator: Qi Li, MD,PhD         
Sponsors and Collaborators
First Affiliated Hospital of Chongqing Medical University

Responsible Party: Qi Li, Professor, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03085472     History of Changes
Other Study ID Numbers: X1517
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qi Li, First Affiliated Hospital of Chongqing Medical University:
intracerebral hemrrohage
stroke
China
hematoma
CT
predictor
prognosis
outcome

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Hematoma
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases