Guy's and St Thomas' Paediatric Thrombosis Registry
| ISRCTN | ISRCTN63203157 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63203157 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/03/2010
- Registration date
- 01/07/2010
- Last edited
- 15/03/2016
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Centre for Haemostasis & Thrombosis
1st Floor, North Wing
St. Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)20 7188 2802 |
|---|---|
| jayanthi.alamelu@gstt.nhs.uk |
Study information
| Study design | Retrospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Other |
| 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 |
| Study acronym | PaedCLOT |
| Study objectives | PaedCLOT is a registry to collect epidemiological and treatment data on neonatal and paediatric thrombosis. |
| Ethics approval(s) | South East London REC 2 (formerly St Thomas' REC), 25/05/2010, ref: 10/H0802/36 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2010 |
| Completion date | 01/05/2050 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Key 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 |
| Key exclusion criteria | Lack of documented thrombosis |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 01/05/2050 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 7EH
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department
16th Floor Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Phone | +44 (0)20 7188 5736 |
|---|---|
| karen.ignatian@nhs.net | |
| Website | http://www.guysandstthomas.nhs.uk/ |
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/03/2016: Plain English summary added.
