Lateral Sinus ThrombosisCSVT PCRNCT03864055

Otogenic CSVT Retrospective Case Series and Associated Thrombophilia

An observational study of Lateral Sinus Thrombosis and Mastoiditis, run by HaEmek Medical Center, Israel at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages Up to 18 yearsHealthy volunteers can take part
Conditions the study is for: Lateral Sinus Thrombosis, Mastoiditis, Otitis Media
How many people: 9 participants
Where: 1 siteIsrael
Study dates: 2 Dec 2018to 3 Feb 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: Children with otogenic CSVT

Who may be able to join

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

Show all 9Show fewer

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Israel1 site

HaEmek Medical Center
Afula, 1834111

Other trials in Israel

About this study

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

Read the 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

Conditions: Lateral Sinus Thrombosis, Mastoiditis, Otitis Media
Keywords: otitis media, mastoiditis, Lateral Sinus Thrombosis, subperiosteal abscess, sigmoid sinus, mastoid, mastoidectomy, ventilation tube
Medical subject headings: Lateral Sinus Thrombosis, Mastoiditis, Otitis Media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03864055
Study group	Role	What they receive
Pediatric Otogenic CSVT		Children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Presentation
Clinical presentation signs and symptoms will be collected and a summary will be represented in a table including all subjects
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Common diagnosis and distribution of CSVT as mentioned by the radiologist's reports
Measured: All cases and follow up documentation reported up to a designated date 31 August 2018 predetermined by the institutional ethics committee

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 20183 Feb 2019

First posted6 Mar 2019
Study start2 Dec 2018
Primary completion3 Feb 2019
Study completion3 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Lateral Sinus ThrombosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03864055
Sponsor's protocol ID: 108-18-EMC
Acronym: CSVT PCR
Status last verified: Mar 2019
First submitted: 23 Feb 2019
Last updated: 6 Mar 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ichord R. Cerebral Sinovenous Thrombosis. Front Pediatr. 2017 Jul 27;5:163. doi: 10.3389/fped.2017.00163. eCollection 2017.
PubMed 28798906
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.
PubMed 17729250
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.
PubMed 29530427
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.
PubMed 15467900
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.
PubMed 26590005
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.
PubMed 23639339
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.
PubMed 17560171
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.
PubMed 17707917
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.
PubMed 11496852
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.
PubMed 19758711
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.
PubMed 17681615

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Otogenic Cerebral Sinus Vein Thrombosis in Children: Retrospective Case Series and Associated Thrombophilia
ClinicalTrials.gov ID: NCT03864055
Acronym / sponsor ID: CSVT PCR / 108-18-EMC
Conditions: Lateral Sinus Thrombosis, Mastoiditis, Otitis Media
Keywords: otitis media, mastoiditis, Lateral Sinus Thrombosis, subperiosteal abscess, sigmoid sinus, mastoid, mastoidectomy, ventilation tube
Study type: Observational
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: HaEmek Medical Center, IsraelUniversity, hospital or other
Study start: 2 Dec 2018 (actual)
Primary completion: 3 Feb 2019 (actual)
Study completion: 3 Feb 2019 (actual)
First posted: 6 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Pediatric Otogenic CSVT	–	–Children with Otogenic Cerebral Sinus Vein Thrombosis (CSVT)

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Children with otogenic CSVT

Key inclusion criteria (9 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
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
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.
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.
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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
Background: PubMed 28798906Ichord R. Cerebral Sinovenous Thrombosis. Front Pediatr. 2017 Jul 27;5:163. doi: 10.3389/fped.2017.00163. eCollection 2017.
Background: PubMed 17729250Skinner 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.
Background: PubMed 29530427Schneider 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.
Background: PubMed 15467900Kenet 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.
Background: PubMed 26590005Zanoletti 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.
Background: PubMed 23639339Novoa 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.
Background: PubMed 17560171Kenet 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.
Background: PubMed 17707917Kvaerner 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.
Background: PubMed 11496852deVeber 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.
Background: PubMed 19758711Pang 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.
Background: PubMed 17681615Palma 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kfir Siag, MD principal investigator

haemek medical center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lateral Sinus Thrombosis and Mastoiditis, run by HaEmek Medical Center, Israel at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03864055, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.