- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05714735
SMCV Assessment on Brain Swelling in Patients With SAH From Ruptured Artery Aneurysm (SMCV)
February 3, 2023 updated by: Xuanwu Hospital, Beijing
Assessment of Superficial Cerebral Venous Structures in Brain Swelling in Patients With Subarachnoid Hemorrhage From Anterior Communicating Artery Aneurysmal
Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations.To explore the relationship between the structure of middle and superficial cerebral veins in cerebral angiography and cerebral edema after ischemia-reperfusion of anterior circulation with large core infarction.
Study Type
Observational
Enrollment (Anticipated)
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
-
Shenzhen, Guangdong, China, 518000
- The People Hospital of Shenzhen Baoan
-
-
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with anterior circulation aneurysmal subarachnoid hemorrhage
Description
Inclusion criteria:
- age 18-70 years;
- Hunt-Hess grade IV-V on admission; single aneurysm in the anterior circulation; interventional embolization of aneurysm is the first choice, and preoperative ventricular puncture drainage and intracranial pressure probe placement.
Exclusion criteria:
- Hunt-Hess grade I-III on admission;
- patients with blood bubble-like aneurysm or accompanying intracranial hematoma who are not suitable for interventional embolization; those who directly choose craniotomy and clipping;
- poor general condition or combined with pregnancy , malignant tumors, etc.
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 |
---|---|
Whole-brain venography
Cerevbral venography
|
Cerebral Venography Observation by DSA examinations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: One year
|
Death
|
One year
|
Bleeding events
Time Frame: One year
|
Intracerebral Hemorrhage
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain swelling
Time Frame: One year
|
Brain swelling score
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: qiaoyu huang, M.D, 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)
November 1, 2017
Primary Completion (ACTUAL)
December 7, 2019
Study Completion (ANTICIPATED)
December 30, 2023
Study Registration Dates
First Submitted
January 27, 2023
First Submitted That Met QC Criteria
February 3, 2023
First Posted (ACTUAL)
February 6, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2023
Last Update Submitted That Met QC Criteria
February 3, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAOAN SMCV in SAH
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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