Otogenic CSVT Retrospective Case Series and Associated Thrombophilia (CSVT PCR)

March 2, 2019 updated by: Kfir Siag, HaEmek Medical Center, Israel

Otogenic Cerebral Sinus Vein Thrombosis in Children: 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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 1834111
        • Haemek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with otogenic CSVT

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pediatric Otogenic CSVT
Children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee
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
All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee
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.
All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee
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.
All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee
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
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
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
All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Kfir Siag, MD, Haemek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2018

Primary Completion (Actual)

February 3, 2019

Study Completion (Actual)

February 3, 2019

Study Registration Dates

First Submitted

February 23, 2019

First Submitted That Met QC Criteria

March 2, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 2, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108-18-EMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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