Otitis Media Clinical Trial
— CSVT PCROfficial title:
Otogenic Cerebral Sinus Vein Thrombosis in Children: Retrospective Case Series and Associated Thrombophilia
Verified date | March 2019 |
Source | HaEmek Medical Center, Israel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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. |
Country | Name | City | State |
---|---|---|---|
Israel | HaEmek Medical Center | Afula |
Lead Sponsor | Collaborator |
---|---|
HaEmek Medical Center, Israel |
Israel,
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
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 |
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