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Completed

NCT Number: NCT03864055

Otogenic CSVT Retrospective Case Series and Associated Thrombophilia

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).

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Key information

Conditions

Lateral Sinus Thrombosis Bone Diseases Bone Diseases, Infectious Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ear Diseases Embolism and Thrombosis Infections Intracranial Embolism and Thrombosis Intracranial Thrombosis Mastoiditis Musculoskeletal Diseases Nervous System Diseases Osteomyelitis Otitis Otitis Media Otorhinolaryngologic Diseases Sinus Thrombosis, Intracranial Thromboembolism Vascular Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HaEmek Medical Center

Afula, 1834111, Israel

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Clinical Presentation

    Time frame: 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

  2. Cultures result

    Time frame: 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

  3. Morbidity and Mortality

    Time frame: 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.

  4. Surgical intervention

    Time frame: 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.

  5. Thrombophilia evaluation tests

    Time frame: 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

Secondary outcomes

  1. Imaging Studies results

    Time frame: 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

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

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

Acronym: CSVT PCR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2019
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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