Stereotactic Aspiration for Primary Brainstem Hemorrhage Based on 'Zhe-er Classification'

May 31, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Descriptive Research on the Effect of Primary Brainstem Hemorrhage Stereotactic Aspiration Based on 'Zhe-er Classification'

The purpose of this study is to determine the benefit of stereotaxic aspiration for patients with primary brainstem hemorrhage with the guidance of 'Zhe-er Classification'

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective study aiming to analyze the clinical record of patients from March 2014 to October 2020. This study is indicated for primary brainstem hemorrhage.

Study Type

Observational

Enrollment (Anticipated)

340

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
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Jianmin Zhang

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with primary brainstem hemorrhage who receive stereotaxic aspiration or conservative therapy from 3/2014 to 10/2020 in 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Description

no new patients will be enrolled within this project

Inclusion Criteria:

  • Patients undergoing a stereotaxic aspiration or conservative therapy from 3/2014 to 10/2020 in 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Exclusion Criteria:

  • patients with secondary brainstem hemorrhage due to blood vessel malformation, trauma, or malignancies

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
Patients received stereotaxic aspiration
No new/additional patients will be enrolled within this project. Only retrospective data will be collected on survival time and life quality
Other: No interventions - retrospective data collection
No new/additional patients will be enrolled within this project.
Patients received conservative therapy
No new/additional patients will be enrolled within this project. Only retrospective data will be collected on survival time and life quality
Other: No interventions - retrospective data collection
No new/additional patients will be enrolled within this project.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival events
Time Frame: 1 year after hemorrhage
Survival events include death, deterioration/recovery of nervous function
1 year after hemorrhage

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Jianmin Zhang, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

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)

November 1, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

May 31, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 31, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-908

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.

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