Condition category
Circulatory System
Date applied
31/03/2010
Date assigned
01/07/2010
Last edited
15/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 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.

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

http://www.guysandstthomas.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

15/03/2016: Plain English summary added.