Primary Brainstem HemorrhageNCT04910490
Stereotactic Aspiration for Primary Brainstem Hemorrhage Based on 'Zhe-er Classification'
An observational study of Primary Brainstem Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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' Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Brainstem Hemorrhage
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients undergoing a stereotaxic aspiration or conservative therapy from 3/2014 to 10/2020 in 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Who cannot join
- patients with secondary brainstem hemorrhage due to blood vessel malformation, trauma, or malignancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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'
Read the 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.
- Conditions
- Primary Brainstem Hemorrhage
- Being tested
- No interventions - retrospective data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions - retrospective data collectionOther
No new/additional patients will be enrolled within this project.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: No interventions - retrospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival events
Survival events include death, deterioration/recovery of nervous function
Measured: 1 year after hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Nov 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Brainstem HemorrhageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianmin Zhang, MD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910490
- Sponsor's protocol ID
- 2020-908
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36908614
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Research on the Effect of Primary Brainstem Hemorrhage Stereotactic Aspiration Based on 'Zhe-er Classification'
- ClinicalTrials.gov ID
- NCT04910490
- Acronym / sponsor ID
- 2020-908
- Conditions
- Primary Brainstem Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients received stereotaxic aspiration | – | Other: No interventions - retrospective data collectionNo new/additional patients will be enrolled within this project. Only retrospective data will be collected on survival time and life quality |
| Patients received conservative therapy | – | Other: No interventions - retrospective data collectionNo new/additional patients will be enrolled within this project. Only retrospective data will be collected on survival time and life quality |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients undergoing a stereotaxic aspiration or conservative therapy from 3/2014 to 10/2020 in 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Key exclusion criteria (1 listed)
- patients with secondary brainstem hemorrhage due to blood vessel malformation, trauma, or malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions - retrospective data collectionNo new/additional patients will be enrolled within this project. | Other | Patients received conservative therapy, Patients received stereotaxic aspiration |
Primary outcome
Survival events
Time frame: 1 year after hemorrhage
Survival events include death, deterioration/recovery of nervous function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 36908614Zhou 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianmin Zhang, MD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Brainstem Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival events (time frame: 1 year after hemorrhage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.