Chongqing Intracerebral Hemorrhage Study

NCT03085472 | Unknown DMC

• 1 other identifier: X1517
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage; Stroke; Hematoma

Keywords

intracerebral hemrrohage; stroke; China; hematoma; CT; predictor; prognosis; outcome

Outcome Measures

Primary Outcomes (1)

• hematoma volume growth at 24 hours

  To assess early hematoma volume growth at 24 hours

  24 hours

Secondary Outcomes (8)

• functional outcome at 3 months assessed by modified Ranking Scale

  3 months

• early neurological deterioration assessed by NIHSS score at 24 hours

  24 hours

• early neurological deterioration assessed by NIHSS at 48 hours

  48 hours

• early neurological deterioration assessed by NIHSS score

  72hours

• perihematoma edema volume measurement at 24 hours

  24 hours

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

18 Years and older (Adult patients)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke; Hematoma

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qi Li, MD;PhD

CONTACT

86 18523381983; qili_md@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 21, 2017
• Study Start: February 16, 2017
• Primary Completion: February 1, 2019
• Study Completion: January 1, 2023
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

CN (1)