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Otogenic CSVT Retrospective Case Series and Associated Thrombophilia

Otogenic Cerebral Sinus Vein Thrombosis in Children: Retrospective Case Series and Associated Thrombophilia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03864055
Acronym
CSVT PCR
Enrollment
9
Registered
2019-03-06
Start date
2018-12-02
Completion date
2019-02-03
Last updated
2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Sinus Thrombosis, Mastoiditis, Otitis Media

Keywords

otitis media, mastoiditis, Lateral Sinus Thrombosis, subperiosteal abscess, sigmoid sinus, mastoid, mastoidectomy, ventilation tube

Brief summary

The aim of this study is to report the clinical presentation, Microbiological, laboratory and imaging evaluation, prothrombotic factors analysis, medical and surgical management and outcomes in children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT).

Detailed description

Objective: Otogenic Cerebral Sinus Vein Thrombosis (CSVT) is a rare but serious intracranial complication of otitis media in children. The aim of this study is to report the clinical presentation, Microbiological, laboratory and imaging evaluation, prothrombotic factors analysis, medical and surgical management and outcomes in children with otogenic CSVT. Study design: Retrospective case series

Interventions

None listed

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* age of 18 years or younger * both sexes are included * a clinical or radiological finding of mastoiditis in the patient's file * Documentation of CSVT in an imaging study, either CT or MRI. Patient's

Exclusion criteria

* age above 18 years * lack of a clinical or radiological finding of mastoiditis in the patient's file * Lack of documentation of CSVT in an imaging study, either CT or MRI. * previous unprovoked venous thromboembolism event.

Design outcomes

Primary

MeasureTime frameDescription
Clinical PresentationAll cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committeeClinical presentation signs and symptoms will be collected and a summary will be represented in a table including all subjects
Cultures resultAll cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committeethe results of cultures from blood, ear secretions, surgery samples, and PCR(polymerize chain reaction assay) will be summarized for the percentage of each pathogen and number of positive results from each type of test
Morbidity and MortalityAll cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committeeThe percentage of Morbidity and Mortality until the end of the follow-up period. Morbidity will include any long term sequelae including permanent neurological deficits, chronic ear inflammation, recurrent mastoiditis, and recurrent thromboembolic events.
Surgical interventionAll cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committeeSummary of all surgical interventions, and determination of the common types of surgery performed.
Thrombophilia evaluation testsAll cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committeeThrombophilia evaluation test results will be collected and a summary will be represented in a table including all subjects

Secondary

MeasureTime frameDescription
Imaging Studies resultsAll cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committeeCommon diagnosis and distribution of CSVT as mentioned by the radiologist's reports

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026