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ISRCTN
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ISRCTN63203157
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ClinicalTrials.gov identifier
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Public title
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Guy's and St Thomas' Paediatric Thrombosis Registry
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Scientific title
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Collecting epidemiological and treatment data on neonatal and paediatric thrombosis in the Guy's and St Thomas' Paediatric Thrombosis Registry: a retrospective observational study
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Acronym
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PaedCLOT
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Serial number at source
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N/A
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Study hypothesis
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PaedCLOT is a registry to collect epidemiological and treatment data on neonatal and paediatric thrombosis.
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Lay summary
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Ethics approval
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South East London REC 2 (formerly St Thomas' REC) approved on the 25th May 2010 (ref: 10/H0802/36)
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Study design
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Retrospective observational study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Paediatric thrombosis
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Participants - inclusion criteria
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1. Patients with a clinical or radiological diagnosis of thrombosis
2. Aged less than 18 years, either sex
3. Consent for addition to the Registry
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Participants - exclusion criteria
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Lack of documented thrombosis
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Anticipated start date
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01/05/2010
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Anticipated end date
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01/05/2050
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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1000
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Interventions
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Study design and methodology:
This is a registry requiring the collection of baseline and follow up clinical and routine laboratory data on patients presenting with thrombosis. No additional investigation will be required as part of participation in this registry. All tests performed will be part of the patient’s normal diagnostic analysis.
Patient population:
Children (under 18 years of age) presenting with thrombosis will be included in the registry. The patients may have had a previous episode of thrombosis or be new cases. All patients will require consent signed by a parent or legal guardian. Patients must have clinically or radiologically identified documented thrombosis.
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Primary outcome measure(s)
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Determine the incidence, distribution of cases and epidemiology of neonatal and paediatric thrombosis in the UK, measured as timepoint of entry to the registry.
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Secondary outcome measure(s)
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1. Identifying associated risk factors in paediatric thrombosis
2. Treatment practices currently used
3. Morbidity with outcome data
4. Mortality data
Measured both at the time of entry and follow-up over time in cases that would be otherwise reviewed upto a year or longer if there are any long term complications.
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Sources of funding
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Sanofi Aventis (UK)
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Trial website
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Publications
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Contact name
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Dr
Jayanthi
Alamelu
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Address
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Centre for Haemostasis & Thrombosis
1st Floor, North Wing
St. Thomas' Hospital
Westminster Bridge Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 2802
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Fax
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+44 (0)20 7401 3125
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Email
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jayanthi.alamelu@gstt.nhs.uk
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Sponsor
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Guy's and St. Thomas' NHS Foundation Trust (UK)
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Address
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R&D Department
16th Floor Tower Wing
Guy's Hospital
Great Maze Pond
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 5736
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Fax
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+44 (0)20 7188 1295
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Email
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karen.ignatian@nhs.net
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Sponsor website:
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http://www.guysandstthomas.nhs.uk/
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Date applied
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31/03/2010
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Last edited
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01/07/2010
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Date ISRCTN assigned
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01/07/2010
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