SMCV Assessment on Brain Swelling in Patients With SAH Fr... | NCT05714735

Studies
SMCV Assessment on Brain Swelling in Patients With SAH From Ruptured Artery Aneurysm

NCT05714735

Sponsor

Xuanwu Hospital, Beijing

Status

Unknown status

Last Update Posted

Feb 6, 2023Actual

Enrollment

198Estimated

Phase

Not provided

Conditions

Arterial Aneurysm

Interventions

Cerebral Venography

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

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Dec 7, 2019Actual

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Jan 27, 2023

First Submission Date that Met QC Criteria

Feb 3, 2023

First Posted Date

Feb 6, 2023Actual

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

Feb 3, 2023

Last Update Posted Date

Feb 6, 2023Actual

Name	Class
The People Hospital of Baoan Shenzhen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

198Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Whole-brain venography		Cerevbral venography	Radiation: Cerebral Venography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cerebral Venography	Radiation	Cerebral Venography Observation by DSA examinations	Whole-brain venography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death	Death	One year
Bleeding events	Intracerebral Hemorrhage	One year

Secondary Outcomes

Measure	Description	Time Frame
Brain swelling	Brain swelling score	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

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

patients with anterior circulation aneurysmal subarachnoid hemorrhage

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
qiaoyu huang, M.D	The People Hospital of Shenzhen Baoan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The People Hospital of Shenzhen Baoan		Shenzhen	Guangdong	518000	China

Condition Browse Module

MeSH Terms

ID	Term
D001929	Brain Edema

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided