Clinical trial NCT03864055: Otogenic CSVT Retrospective Case Series and Associated Thrombophilia
Official title: Otogenic Cerebral Sinus Vein Thrombosis in Children: Retrospective Case Series and Associated Thrombophilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lateral Sinus Thrombosis
Mastoiditis
Otitis Media
Keywords: otitis media
mastoiditis
Lateral Sinus Thrombosis
subperiosteal abscess
sigmoid sinus
mastoid
mastoidectomy
ventilation tube
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 9
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with otogenic CSVT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Presentation
timeFrame: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee
measure: Cultures result
timeFrame: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee
measure: Morbidity and Mortality
timeFrame: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee
measure: Surgical intervention
timeFrame: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee
measure: Thrombophilia evaluation tests
timeFrame: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee
Secondary outcomes:
measure: Imaging Studies results
timeFrame: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: haemek medical center
name: Kfir Siag, MD
role: PRINCIPAL_INVESTIGATOR
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