The United Kingdom Thrombotic Thrombocytopenic Purpura Registry (UK TTP Registry)

February 5, 2019 updated by: University College, London

The United Kingdom Thrombotic Thrombocytopenic Purpura Registry

This is a UK (United Kingdom) based registry, involving all sites treating newly presenting Thrombotic Thrombocytopenic Purpura (TTP). From this registry, important epidemiological data will be obtained. Admission and remission samples will be collected. DNA will be collected and analysed from patients wishing to participate to determine if any link exists between mutations/polymorphisms and the risk of TTP. As part of NHS commissioning, we will be undertaking long term follow up, to understand the impact of acute TTP on morbidity and mortality.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting with an acute episode of Thrombotic Thrombocytopenic Purpura (TTP) will be asked to consent for the registry once in remission. However, for those sites undertaking ADAMTS13 analysis, consent for admission and remission samples for TTP cases will be requested. A screening log of all cases analysed will be kept by sites and forwarded at 3 monthly intervals. This will help identify other non-TTP causes for ADAMTS13 analysis.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

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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