NCT04189068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2019

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

16 days

First QC Date

October 30, 2019

Last Update Submit

December 5, 2019

Conditions

Magnetic Resonance Angiography

Keywords

Cerebral Infarction Hyaluronic Acid Embolism

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of cerebral infarction

You may not qualify if:

  • fat embolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qing

Xi'an, Shaan XI Province, 710032, China

Location

Related Publications (1)

  • 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.

    PMID: 26763725BACKGROUND

Study Officials

  • Ma

    Xijing Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Clinical research

Study Record Dates

First Submitted

October 30, 2019

First Posted

December 6, 2019

Study Start

September 24, 2019

Primary Completion

October 10, 2019

Study Completion

October 22, 2019

Last Updated

December 6, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)