The Role of Deep Cerebral Vein Variation in Patients With... | NCT04941846

Studies
The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage

NCT04941846

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Jun 28, 2021Actual

Enrollment

296Estimated

Phase

Not provided

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Interventions

nimodipine and euvolemia

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013Actual

Primary Completion Date

Jan 2023Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Jun 18, 2021

First Submission Date that Met QC Criteria

Jun 18, 2021

First Posted Date

Jun 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2021

Last Update Posted Date

Jun 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

296Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nimodipine and euvolemia	Drug	administered nimodipine to prevent vasospasm, and euvolemia was maintained via intravenous hydration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
favorable or poor outcome	poor outcome (mRS 2-6) or favorable outcome (mRS 0-1).	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

This project plans to include 296 patients who meet the admission and discharge criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianmin Zhang, MD	Contact	+86 13805722695		zjm135@zju.edu.cn
Sheng Chen, MD	Contact	+86 13645814323		saintchan@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Yuanjian Fang, MD	2ndAffiliated Hospital, School of Medicine, Zhejiang University, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2ndAffiliated Hospital, School of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310009	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013345	Subarachnoid Hemorrhage

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009553	Nimodipine

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided