Plain English Summary
Background and study aims
Thrombosis occurs when a blood clot forms inside a blood vessel and obstructs the flow of blood. The aim of this study is to collect data on thrombosis occurring in patients aged under 18 (neonatal and paediatric thrombosis).
Who can participate?
Children (under 18 years of age) who have been diagnosed with thrombosis
What does the study involve?
We collect clinical and routine laboratory data on patients with thrombosis. No additional investigation is required and all tests performed are part of the patient’s normal diagnostic analysis.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
St Thomas' Hospital (UK)
When is the study starting and how long is it expected to run for?
May 2010 to May 2050
Who is funding the study?
Sanofi Aventis (UK)
Who is the main contact?
Dr Jayanthi Alamelu
jayanthi.alamelu@gstt.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jayanthi Alamelu
ORCID ID
Contact details
Centre for Haemostasis & Thrombosis
1st Floor
North Wing
St. Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 (0)20 7188 2802
jayanthi.alamelu@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Collecting epidemiological and treatment data on neonatal and paediatric thrombosis in the Guy's and St Thomas' Paediatric Thrombosis Registry: a retrospective observational study
Acronym
PaedCLOT
Study hypothesis
PaedCLOT is a registry to collect epidemiological and treatment data on neonatal and paediatric thrombosis.
Ethics approval
South East London REC 2 (formerly St Thomas' REC), 25/05/2010, ref: 10/H0802/36
Study design
Retrospective observational study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
Paediatric thrombosis
Intervention
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 patients 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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Determine the incidence, distribution of cases and epidemiology of neonatal and paediatric thrombosis in the UK, measured as timepoint of entry to the registry.
Secondary outcome measures
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.
Overall trial start date
01/05/2010
Overall trial end date
01/05/2050
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1000
Participant exclusion criteria
Lack of documented thrombosis
Recruitment start date
01/05/2010
Recruitment end date
01/05/2050
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St. Thomas' NHS Foundation Trust (UK)
Sponsor details
R&D Department
16th Floor Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 (0)20 7188 5736
karen.ignatian@nhs.net
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Sanofi Aventis (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary