Otogenic CSVT Retrospective Case Series and Associated Thrombophilia

Otitis Media Clinical Trial

— CSVT PCR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864055
• Other study ID #: 108-18-EMC
• Status: Completed
• Start date: December 2, 2018
• Est. completion date: February 3, 2019

Study information

• Verified date: March 2019
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 3, 2019
• Est. primary completion date: February 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lateral Sinus Thrombosis
• Mastoiditis
• Otitis
• Otitis Media
• Sinus Thrombosis, Intracranial
• Thrombophilia
• Thrombosis

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (11)

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. — View Citation

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

Kenet G, Kirkham F, Niederstadt T, Heinecke A, Saunders D, Stoll M, Brenner B, Bidlingmaier C, Heller C, Knöfler R, Schobess R, Zieger B, Sébire G, Nowak-Göttl 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. — View Citation

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. — View Citation

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. Epub 2007 Aug 20. — View Citation

Novoa E, Podvinec M, Angst R, Gürtler 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. Review. — View Citation

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. Epub 2007 Aug 2. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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