- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05696639
SMCV Assessment on Brain Swelling in Patients With SAH (Bayysmcv)
January 13, 2023 updated by: Shenzhen Baoan District People's Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
198
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
-
-
Guangdong
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Shenzhen, Guangdong, China, 518000
- Shenzhen Baoan People's Hospital
-
-
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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
patients with anterior communicating aneurysm
Exclusion Criteria:
Hunt-Hess grade I- patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors were excluded.
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Undeveloped venous group
patients with undeveloped cerebral venous
|
All patients underwent Aneurysm embolization surgery, the cerebral venous will be observed intraoperatively.
|
|
Well Developed venous group
patients with well-developed cerebral venous
|
All patients underwent Aneurysm embolization surgery, the cerebral venous will be observed intraoperatively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
brain swelling
Time Frame: 2 weeks
|
grading of brain swelling
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: JIangang Hu, Phd, The People Hospital of Shenzhen Baoan
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)
April 1, 2017
Primary Completion (Actual)
December 1, 2022
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
January 13, 2023
First Submitted That Met QC Criteria
January 13, 2023
First Posted (Estimate)
January 24, 2023
Study Record Updates
Last Update Posted (Estimate)
January 24, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BYL20220216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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