Otogenic CSVT Retrospective Case Series and Associated Thrombophilia

NCT03864055 | Completed

• 1 other identifier: 108-18-EMC
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Lateral Sinus Thrombosis; Mastoiditis; Otitis Media

Keywords

otitis media; mastoiditis; Lateral Sinus Thrombosis; subperiosteal abscess; sigmoid sinus; mastoid; mastoidectomy; ventilation tube

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Imaging Studies results

  All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee

Study Arms (1)

Pediatric Otogenic CSVT

Children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with otogenic CSVT

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

HaEmek Medical Center

Afula, 1834111, Israel

Location

Related Publications (11)

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

  PMID: 28798906 BACKGROUND

• 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.

  PMID: 17729250 BACKGROUND

• 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.

  PMID: 29530427 BACKGROUND

• 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.

  PMID: 15467900 BACKGROUND

• 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.

  PMID: 26590005 BACKGROUND

• 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.

  PMID: 23639339 BACKGROUND

• 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.

  PMID: 17560171 BACKGROUND

• 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.

  PMID: 17707917 BACKGROUND

• 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.

  PMID: 11496852 BACKGROUND

• 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.

  PMID: 19758711 BACKGROUND

• 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.

  PMID: 17681615 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

cultures from blood, ear secretions and samples collected during a surgical procedure. also PCR (polymerase chain reaction assay) analysis for bacterial RNA.

MeSH Terms

Conditions

Lateral Sinus Thrombosis; Mastoiditis; Otitis Media

Condition Hierarchy (Ancestors)

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

Study Officials

• Kfir Siag, MD

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Siag Kfir

Study Record Dates

• First Submitted: February 23, 2019
• First Posted: March 6, 2019
• Study Start: December 2, 2018
• Primary Completion: February 3, 2019
• Study Completion: February 3, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

IL (1)