AneurysmBayysmcvNCT05696639
SMCV Assessment on Brain Swelling in Patients With SAH
An observational study of Aneurysm and Subarachnoid Hemorrhage, run by Shenzhen Baoan District People's Hospital at 1 site in China.
Trial summary
Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage.This study is a retrospective cohort aimed to predict the extent of brain swelling. Cerebral venous assessment can identify the risk of brain swelling and improve surgical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aneurysm, Subarachnoid Hemorrhage, Brain Swelling
- What is being tested?
- Aneurysm embolization
- Type of treatment
- Surgery or procedure
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 30 Dec 2023
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients with an anterior communicating aneurysmal subarachnoid hemorrhage between January 2017 and December 2022 who underwent aneurysm embolization surgery, excluding patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors.
Who may be able to join
- patients with anterior communicating aneurysm
Who cannot join
- Hunt-Hess grade I- patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Venous Assessment on Brain Swelling in Patients With Aneurysm Subarachnoid Hemorrhage: Retrospective Cohort Study
Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage.This study is a retrospective cohort aimed to predict the extent of brain swelling. Cerebral venous assessment can identify the risk of brain swelling and improve surgical outcomes.
Read the detailed description
Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage (SAH).This study is a retrospective cohort aimed to predict the extent of brain swelling (BS). Cerebral venous assessment can identify the risk of cerebral swelling and improve surgical outcomes. This study is a retrospective cohort analysis. Cerebral venous angiography (CVA) will be adopted and the superficial middle cerebral vein (SMCVs) will be evaluated.
- Conditions
- Aneurysm, Subarachnoid Hemorrhage, Brain Swelling
- Being tested
- Aneurysm embolization
- Medical subject headings
- Aneurysm, Subarachnoid Hemorrhage, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aneurysm embolizationProcedure or surgery
All patients underwent Aneurysm embolization surgery, the cerebral venous will be observed intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Undeveloped venous group | patients with undeveloped cerebral venous Receives: Procedure: Aneurysm embolization | |
| Well Developed venous group | patients with well-developed cerebral venous Receives: Procedure: Aneurysm embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain swelling
grading of brain swelling
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Apr 2017
- Primary completion1 Dec 2022
- Study completion30 Dec 2023 (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 AneurysmStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Baoan District People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JIangang Hu, Phd, Study director, The People Hospital of Shenzhen Baoan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696639
- Sponsor's protocol ID
- BYL20220216
- Acronym
- Bayysmcv
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang Y, Hu J. Effects of low-dose intravenous heparin therapy in aneurysmal subarachnoid hemorrhage: a randomized controlled clinical trial protocol. Trials. 2023 Jul 8;24(1):447. doi: 10.1186/s13063-023-07493-9.
PubMed 37422666
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Venous Assessment on Brain Swelling in Patients With Aneurysm Subarachnoid Hemorrhage: Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05696639
- Acronym / sponsor ID
- Bayysmcv / BYL20220216
- Conditions
- Aneurysm, Subarachnoid Hemorrhage, Brain Swelling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Shenzhen Baoan District People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 25 Jan 2023 (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.
Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage.This study is a retrospective cohort aimed to predict the extent of brain swelling. Cerebral venous assessment can identify the risk of brain swelling and improve surgical outcomes.
Detailed description
Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage (SAH).This study is a retrospective cohort aimed to predict the extent of brain swelling (BS). Cerebral venous assessment can identify the risk of cerebral swelling and improve surgical outcomes. This study is a retrospective cohort analysis. Cerebral venous angiography (CVA) will be adopted and the superficial middle cerebral vein (SMCVs) will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Undeveloped venous group | – | Procedure: Aneurysm embolizationpatients with undeveloped cerebral venous |
| Well Developed venous group | – | Procedure: Aneurysm embolizationpatients with well-developed cerebral venous |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with an anterior communicating aneurysmal subarachnoid hemorrhage between January 2017 and December 2022 who underwent aneurysm embolization surgery, excluding patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors.
Key inclusion criteria (1 listed)
- patients with anterior communicating aneurysm
Key exclusion criteria (1 listed)
- Hunt-Hess grade I- patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors were excluded.
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 |
|---|---|---|
| Aneurysm embolizationAll patients underwent Aneurysm embolization surgery, the cerebral venous will be observed intraoperatively. | Procedure or surgery | Undeveloped venous group, Well Developed venous group |
Primary outcome
brain swelling
Time frame: 2 weeks
grading of brain swelling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 37422666Zhang Y, Hu J. Effects of low-dose intravenous heparin therapy in aneurysmal subarachnoid hemorrhage: a randomized controlled clinical trial protocol. Trials. 2023 Jul 8;24(1):447. doi: 10.1186/s13063-023-07493-9.
- Individual participant dataSharing planned: Undecided
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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.
JIangang Hu, Phd study director
The People Hospital of Shenzhen Baoan
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 Aneurysm and Subarachnoid Hemorrhage, run by Shenzhen Baoan District People's Hospital 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 25 Jan 2023. 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?
brain swelling (time frame: 2 weeks). 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 NCT05696639, 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 25 Jan 2023.