Subarachnoid Hemorrhage, AneurysmalNCT04941846
The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- nimodipine and euvolemia
- Type of treatment
- Injection or infusion
- How many people
- 296 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jan 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: This project plans to include 296 patients who meet the admission and discharge criteria
Who may be able to join
- Patients with negative subarachnoid hemorrhage diagnosed by DSA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2ndAffiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Jianmin Zhang, MD, +86 13805722695, zjm135@zju.edu.cn
Sheng Chen, MD, +86 13645814323, saintchan@zju.edu.cn
About this study
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.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- nimodipine and euvolemia
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nimodipine and euvolemiaDrug
administered nimodipine to prevent vasospasm, and euvolemia was maintained via intravenous hydration
What is being measured
The primary outcome is the main question the study is designed to answer.
favorable or poor outcome
poor outcome (mRS 2-6) or favorable outcome (mRS 0-1).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study startJan 2013
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuanjian Fang, MD, Principal investigator, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941846
- Sponsor's protocol ID
- 2020111
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT04941846
- Acronym / sponsor ID
- 2020111
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 28 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 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This project plans to include 296 patients who meet the admission and discharge criteria
Key inclusion criteria (1 listed)
- Patients with negative subarachnoid hemorrhage diagnosed by DSA
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| nimodipine and euvolemiaadministered nimodipine to prevent vasospasm, and euvolemia was maintained via intravenous hydration | Drug | – |
Primary outcome
favorable or poor outcome
Time frame: 1 year
poor outcome (mRS 2-6) or favorable outcome (mRS 0-1).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Yuanjian Fang, MD principal investigator
2ndAffiliated 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 Subarachnoid Hemorrhage, Aneurysmal, 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 3 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 28 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?
Contact Jianmin Zhang, MD (+86 13805722695, zjm135@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
favorable or poor outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2021.