Otogenic CSVT Retrospective Case Series and Associated Thrombophilia

Study Overview
=================
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

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

Conditions
-----------------
Lateral Sinus Thrombosis, Mastoiditis, Otitis Media

Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Otogenic CSVT<br>Children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT) | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mastoiditis, otitis media, Lateral Sinus Thrombosis, subperiosteal abscess, sigmoid sinus, mastoid, mastoidectomy, ventilation tube