- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04941846
The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage
June 18, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
The incidence of Rosenthal basilar vein (BVR) variants (deep venous drainage variants) was relatively increased in patients with AN-SAH compared with patients with aneurysms.
However, the inclusion criteria for AN-SAH patients in these studies were different.
Some studies have investigated both PAN-SAH and NPAN-SAH, while some studies have only investigated PAN-SAH patients.
However, we believe that NPAN-SAH may be the bleeding caused by non-BVR variation.
Although previous studies did not find any association between NPAN-SAH and BVR variants, the results in their study were different, which may be due to the limited number of cases.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
296
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianmin Zhang, MD
- Phone Number: +86 13805722695
- Email: zjm135@zju.edu.cn
Study Contact Backup
- Name: Sheng Chen, MD
- Phone Number: +86 13645814323
- Email: saintchan@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Recruiting
- 2ndAffiliated Hospital, School of Medicine, Zhejiang University
-
Contact:
- Jianmin Zhang, MD
- Phone Number: +86 13805722695
- Email: zjm135@zju.edu.cn
-
Contact:
- Sheng Chen, MD
- Phone Number: +86 13645814323
- Email: saintchan@zju.edu.cn
-
Principal Investigator:
- Yuanjian Fang, MD
-
-
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
This project plans to include 296 patients who meet the admission and discharge criteria
Description
Inclusion Criteria:
Patients with negative subarachnoid hemorrhage diagnosed by DSA
Exclusion Criteria:
- In patients with aneurysms, external ventricular drainage (EVD) alone or decompression craniotomy alone or conservative treatment was performed
- Have a history of trauma or prior brain injury (stroke, cerebral hemorrhage, etc., with associated chronic changes on CT)
- Patients with loss of imaging data and severe comorditions prior to onset of SAH
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
favorable or poor outcome
Time Frame: 1 year
|
poor outcome (mRS 2-6) or favorable outcome (mRS 0-1).
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yuanjian Fang, MD, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
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)
January 1, 2013
Primary Completion (Anticipated)
January 1, 2023
Study Completion (Anticipated)
January 1, 2023
Study Registration Dates
First Submitted
June 18, 2021
First Submitted That Met QC Criteria
June 18, 2021
First Posted (Actual)
June 28, 2021
Study Record Updates
Last Update Posted (Actual)
June 28, 2021
Last Update Submitted That Met QC Criteria
June 18, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Intracranial Hemorrhages
- Hemorrhage
- Subarachnoid Hemorrhage
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Nimodipine
Other Study ID Numbers
- 2020111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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