- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03832881
The United Kingdom Thrombotic Thrombocytopenic Purpura Registry (UK TTP Registry)
The United Kingdom Thrombotic Thrombocytopenic Purpura Registry
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The UK TTP registry started in January 2009, following 3 years MRC funding, involving UK collaboration from all sites treating TTP patients. It has resulted in a cohort of data and samples from UK TTP cases. The registry promotes a collaborative approach with all UK patients and physicians involved with this life threatening disorder. The UK TTP registry has been used to provide information for highly specialist commissioning via NHS England and moving forward will be required to provide data relevant to the UK TTP Group and commissioners.
University College London (UCL) Haemostasis Research Unit (HRU) will collect and collate the data and help administrate for those sites participating in the registry. However, ADAMTS13 assays will no longer be subsidised. For those sites undertaking local assays, a record of cases will be shared centrally. The UK TTP registry will be part of the UK TTP Group.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: I Obu
- Phone Number: 0207 679 6428
- Email: uclh.ttp@nhs.net
Study Locations
-
-
-
London, United Kingdom, NW1 2PG
- Recruiting
- University College London Hospital
-
Contact:
- I Obu
- Phone Number: 0207 679 6428
- Email: uclh.ttp@nhs.net
-
Contact:
- Prof Marie Scully
- Phone Number: 0207 679 6428
- Email: uclh.ttp@nhs.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with a clinical diagnosis of TTP, defined by thrombocytopenia, MAHA which may be associated with clinical evidence of organ compromise.Confirmed by severely reduced ADAMTS13 levels and/or a positive antibody screen.
- No age restriction.
- Consent for addition to the Registry and collection/storage of admission information once in remission.
- Consent to collect, analyse and store EDTA sample once in remission.
- Consent to store samples once in remission (sample taken as part of standard care).
- For sites undertaking ADAMTS13 analysis, consent to send admission and remission samples for analysis relating to TTP.
- Follow up laboratory and clinical data at least yearly to identify any changes.
Exclusion Criteria:
- Patients with cancer or transplant associated MAHA will not be included.
- Patients not wishing to be involved with the registry.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TTP incidence
Time Frame: At study completion, approximately in 2023
|
Number of TTP cases in the UK each year
|
At study completion, approximately in 2023
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08/0264
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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