Fatal Cerebral Infarction After Nasal Augmentation With H... | NCT04189068

Studies
Fatal Cerebral Infarction After Nasal Augmentation With Hyaluronic Acid

NCT04189068

Sponsor

Xijing Hospital

Status

Completed

Last Update Posted

Dec 6, 2019Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Magnetic Resonance Angiography

Interventions

Not provided

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 24, 2019Actual

Primary Completion Date

Oct 10, 2019Actual

Completion Date

Oct 22, 2019Actual

First Submitted Date

Oct 30, 2019

First Submission Date that Met QC Criteria

Dec 5, 2019

First Posted Date

Dec 6, 2019Actual

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

Dec 5, 2019

Last Update Posted Date

Dec 6, 2019Actual

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

this study discussed the pathogenesis, treatment, and prognosis of severe cerebral infarction and ophthalmic artery occlusion for Aisan induced by hyalruonic acid filler injection.

Detailed Description

Intra-arterial thrombolysis and retrobulbar injection of hyaluronidase have been used for HA-induced ophthalmic artery obstruction.

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

1Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pulse	Monitore the "beats per minute over the past 6 days.	0-6 day
blood pressure	Monitor the blood pressure and record with mm Hg over the past 6 days.	0-6 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of cerebral infarction

Exclusion Criteria:

fat embolism

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patient with severe cerebral infarction and ophthalmic artery occlusion after nasal augmentation by HA.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Ma	Xijing Hospital	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Qing		Xi'an	Shaan XI Province	710032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26763725	Background	Li KT, Huang YH, Chen CH, Chou LW. Delayed-onset cerebral infarction after cosmetic facial injection using hyaluronic acid. J Formos Med Assoc. 2016 Jul;115(7):587-8. doi: 10.1016/j.jfma.2015.11.012. Epub 2016 Jan 4. No abstract available.