Otogenic CSVT Retrospective Case Series and Associated Thrombophilia

NCT ID: NCT03864055

Last Updated: 2019-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-02

Study Completion Date

2019-02-03

Brief Summary

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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

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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

Conditions

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Lateral Sinus Thrombosis Mastoiditis Otitis Media

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pediatric Otogenic CSVT

Children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT)

No interventions assigned to this group

Eligibility Criteria

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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.

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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Kfir Siag

Dr. Siag Kfir

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kfir Siag, MD

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

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HaEmek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

References

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Ichord R. Cerebral Sinovenous Thrombosis. Front Pediatr. 2017 Jul 27;5:163. doi: 10.3389/fped.2017.00163. eCollection 2017.

Reference Type BACKGROUND
PMID: 28798906 (View on PubMed)

Skinner R, Koller K, McIntosh N, McCarthy A, Pizer B; United Kingdom Children's Cancer Study Group (UKCCSG); Paediatric Oncology Nursing Forum (PONF) Supportive Care Group. Prevention and management of central venous catheter occlusion and thrombosis in children with cancer. Pediatr Blood Cancer. 2008 Apr;50(4):826-30. doi: 10.1002/pbc.21332.

Reference Type BACKGROUND
PMID: 17729250 (View on PubMed)

Schneider S, Kapelushnik J, Kraus M, El Saied S, Levi I, Kaplan DM. The association between otogenic lateral sinus thrombosis and thrombophilia - A long-term follow-up. Am J Otolaryngol. 2018 May-Jun;39(3):299-302. doi: 10.1016/j.amjoto.2018.03.013. Epub 2018 Mar 7.

Reference Type BACKGROUND
PMID: 29530427 (View on PubMed)

Kenet G, Waldman D, Lubetsky A, Kornbrut N, Khalil A, Koren A, Wolach B, Fattal A, Kapelushnik J, Tamary H, Yacobovitch J, Raveh E, Revel-Vilk S, Toren A, Brenner B. Paediatric cerebral sinus vein thrombosis. A multi-center, case-controlled study. Thromb Haemost. 2004 Oct;92(4):713-8. doi: 10.1160/TH04-03-0182.

Reference Type BACKGROUND
PMID: 15467900 (View on PubMed)

Zanoletti E, Cazzador D, Faccioli C, Sari M, Bovo R, Martini A. Intracranial venous sinus thrombosis as a complication of otitis media in children: Critical review of diagnosis and management. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2398-403. doi: 10.1016/j.ijporl.2015.10.059. Epub 2015 Nov 5.

Reference Type BACKGROUND
PMID: 26590005 (View on PubMed)

Novoa E, Podvinec M, Angst R, Gurtler N. Paediatric otogenic lateral sinus thrombosis: therapeutic management, outcome and thrombophilic evaluation. Int J Pediatr Otorhinolaryngol. 2013 Jun;77(6):996-1001. doi: 10.1016/j.ijporl.2013.03.030. Epub 2013 Apr 29.

Reference Type BACKGROUND
PMID: 23639339 (View on PubMed)

Kenet G, Kirkham F, Niederstadt T, Heinecke A, Saunders D, Stoll M, Brenner B, Bidlingmaier C, Heller C, Knofler R, Schobess R, Zieger B, Sebire G, Nowak-Gottl U; European Thromboses Study Group. Risk factors for recurrent venous thromboembolism in the European collaborative paediatric database on cerebral venous thrombosis: a multicentre cohort study. Lancet Neurol. 2007 Jul;6(7):595-603. doi: 10.1016/S1474-4422(07)70131-X.

Reference Type BACKGROUND
PMID: 17560171 (View on PubMed)

Kvaerner KJ, Bentdal Y, Karevold G. Acute mastoiditis in Norway: no evidence for an increase. Int J Pediatr Otorhinolaryngol. 2007 Oct;71(10):1579-83. doi: 10.1016/j.ijporl.2007.06.022. Epub 2007 Aug 20.

Reference Type BACKGROUND
PMID: 17707917 (View on PubMed)

deVeber G, Andrew M, Adams C, Bjornson B, Booth F, Buckley DJ, Camfield CS, David M, Humphreys P, Langevin P, MacDonald EA, Gillett J, Meaney B, Shevell M, Sinclair DB, Yager J; Canadian Pediatric Ischemic Stroke Study Group. Cerebral sinovenous thrombosis in children. N Engl J Med. 2001 Aug 9;345(6):417-23. doi: 10.1056/NEJM200108093450604.

Reference Type BACKGROUND
PMID: 11496852 (View on PubMed)

Pang LH, Barakate MS, Havas TE. Mastoiditis in a paediatric population: a review of 11 years experience in management. Int J Pediatr Otorhinolaryngol. 2009 Nov;73(11):1520-4. doi: 10.1016/j.ijporl.2009.07.003. Epub 2009 Sep 15.

Reference Type BACKGROUND
PMID: 19758711 (View on PubMed)

Palma S, Fiumana E, Borgonzoni M, Bovo R, Rosignoli M, Martini A. Acute mastoiditis in children: the "Ferrara" experience. Int J Pediatr Otorhinolaryngol. 2007 Nov;71(11):1663-9. doi: 10.1016/j.ijporl.2007.06.018. Epub 2007 Aug 2.

Reference Type BACKGROUND
PMID: 17681615 (View on PubMed)

Other Identifiers

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108-18-EMC

Identifier Type: -

Identifier Source: org_study_id

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