NCT04910490

Brief Summary

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'

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

May 31, 2021

Last Update Submit

May 31, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival events

    Survival events include death, deterioration/recovery of nervous function

    1 year after hemorrhage

Study Arms (2)

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

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

Interventions

No new/additional patients will be enrolled within this project.

Patients received conservative therapyPatients received stereotaxic aspiration

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianmin Zhang

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

  • Zhou J, Wang R, Mao J, Gu Y, Shao A, Liu F, Zhang J. Prognostic models for survival and consciousness in patients with primary brainstem hemorrhage. Front Neurol. 2023 Feb 23;14:1126585. doi: 10.3389/fneur.2023.1126585. eCollection 2023.

Study Officials

  • Jianmin Zhang, MD

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 2, 2021

Study Start

November 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations