Otogenic CSVT Retrospective Case Series and Associated Thrombophilia

Completed

• Conditions: Otitis Media; Lateral Sinus Thrombosis; Mastoiditis

• Registration Number: NCT03864055
• Lead Sponsor: HaEmek Medical Center, Israel

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

Study Timeline

• Study Start: 2018-12-02
• Primary Completion: 2019-02-03
• Study Completion: 2019-02-03
• Study First Submitted: 2019-02-23
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-02
• Last Update Submitted: 2019-03-02
• Study First Posted: 2019-03-06
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cultures result	All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee	the 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
Clinical Presentation	All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee	Clinical presentation signs and symptoms will be collected and a summary will be represented in a table including all subjects
Morbidity and Mortality	All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee	The 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.
Thrombophilia evaluation tests	All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee	Thrombophilia evaluation test results will be collected and a summary will be represented in a table including all subjects
Surgical intervention	All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee	Summary of all surgical interventions, and determination of the common types of surgery performed.

Secondary Outcome Measures

Name	Time	Method
Imaging Studies results	All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee	Common diagnosis and distribution of CSVT as mentioned by the radiologist's reports

Trial Locations

Locations (1)

HaEmek Medical Center; 🇮🇱 Afula, Israel