The Influencing Factors and Prediction Model of Poor Prognosis of Spontaneous Intraparenchymal Hemorrhage

September 20, 2023 updated by: Tang-Du Hospital
This study was designed to explore the influencing factors of spontaneous intraparenchymal hemorrhage's prognosis and develop predictive models for poor prognosis by establishing a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzing the correlation between collected variables and patients' outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Spontaneous intracranial hemorrhage is an important type of cerebrovascular disease. The disease has an acute onset, a serious condition, and a high mortality rate. Besides, the survivors always live with severe neurological dysfunction. It is essential to determine the influencing factors of poor prognosis, estimate patient's condition and predict the prognosis timely.

This study consists of two parts. The first part establishes a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzes the influence of different factors, such as surgical methods, on the prognosis. In the second part, a nested case-control study nested in this cohort will be established to analyse the influence of some other factors. The biological specimens are tested. The collected data were analysed to find out the risk factors of poor prognosis and establish a predictive model.

Recruitment and follow-up of the participants is expected to continue after the initial goal is achieved. As a large sample database of intracranial hemorrhage, this cohort will provide more research data for the future exploration of more clinical problems.

Study Type

Observational

Enrollment (Estimated)

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 Contact

Study Contact Backup

  • Name: Haixiao Liu, M.D
  • Phone Number: 86-15929315407
  • Email: 56761311@qq.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tandu Hospital, Fourth Military Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yan Qu, M.D, Ph.D
        • Principal Investigator:
          • Wei Guo, M.D Ph.D
        • Sub-Investigator:
          • Haixiao Liu, M.D

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All of the spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) patients receiving treatment in four clinical centers (Tangdu Hospital, Ankang Central Hospital, 987 Hospital of PLA Joint Logistic Support Force, and Nuclear Industry 215 Hospital of Shaanxi Province) who meet the screening criteria were invited to participate in this cohort study.

Description

Inclusion Criteria:

  1. Age 18-80；
  2. Diagnosed with spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) by Computed Tomography;
  3. Admitted within 24h of ictus；
  4. Did not undertake treatment before enrollment;
  5. Informed consent to participate in the study.

Exclusion Criteria:

  1. The hemorrhage caused by tumor, arteriovenous malformation, aneurysm or coagulopathy；
  2. Concurrent traumatic brain injury；
  3. Multiple intracerebral hemorrhage；
  4. Undertake any surgery after onset in other hospital；
  5. Refuse the treatment after admission;
  6. History of craniocerebral surgery；
  7. Known advanced demential or disability before onset；
  8. Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
  9. Confirmed malignant disease or life expectancy less than 6 months due to comorbid diseases;
  10. Concurrent serious infectious disease (HIV, tuberculosis etc.)
  11. Concurrent coagulation disorders or having taken anti-platelet or anticoagulant drugs;
  12. With indications of terminal brain hernia
  13. Pregnant or lactating females；
  14. Participation in another simultaneous trial of intracerebral hemorrhage treatment；
  15. Patients/relatives refuse to be followed up。

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spontaneous Supratentorial Intracerebral Haemorrhage
Participants with spontaneous supratentorial intracerebral haemorrhage.
Other: No intervention
No intervention
Spontaneous Intracerebellar Hemorrhage
Participants with spontaneous intracerebellar hemorrhage.
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 1 month after onset
The mortality rate of patients undertook different treatments at 1 month.
1 month after onset
Mortality
Time Frame: 6 month after onset
The mortality rate of patients undertook different treatments at 6 month.
6 month after onset
Mortality
Time Frame: 12 month after onset
The mortality rate of patients undertook different treatments at 12 month.
12 month after onset
Neurological Outcome Assessed by modified Rankin Scale (mRS) Score
Time Frame: 1 month after onset
The neurological function state of patients undertook different treatments at 1 month.
1 month after onset
Neurological Outcome Assessed by mRS Score
Time Frame: 6 month after onset
The neurological function state of patients undertook different treatments at 6 month.
6 month after onset
Neurological Outcome Assessed by mRS Score
Time Frame: 12 month after onset
The neurological function state of patients undertook different treatments at 12 month.
12 month after onset

Collaborators and Investigators

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

Sponsor

Tang-Du Hospital

Investigators

  • Study Chair: Yan Qu, Tang-Du Hospital
  • Study Director: Wei Guo, Tang-Du Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 15, 2019

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

March 31, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDSJWKICH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spontaneous Intracranial Hemorrhage

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe