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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03832881
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Information provided by (Responsible Party):
University College, London

Brief Summary:
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.

Condition or disease Intervention/treatment
TTP - Thrombotic Thrombocytopenic Purpura Diagnostic Test: ADAMTS13, VWF assay

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Other
Official Title: The United Kingdom Thrombotic Thrombocytopenic Purpura Registry
Actual Study Start Date : January 2009
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Primary Outcome Measures :
  1. TTP incidence [ Time Frame: At study completion, approximately in 2023 ]
    Number of TTP cases in the UK each year

Biospecimen Retention:   Samples With DNA

On Admission/Pre-treatment:

• A 5ml double spun citrate sample (platelet free plasma separated) taken on admission and/or pre-treatment. (Part of Standard Care).

In Remission/Approximately 3 months post admission:

  • A 5ml double spun remission citrate sample (platelet free plasma separated) following discharge from the acute episode. (Part of Standard Care)
  • A 5ml EDTA whole blood sample for DNA extraction. (Informed Consent from patient required).
  • A 5ml serum sample. (Sample taken as part of Standard Care; Informed Consent required for storage and use of sample for current and future analysis of parameters related to TTP; Current tests include, IgG subtyping and Rituximab levels.)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03832881

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Contact: I Obu 0207 679 6428

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United Kingdom
University College London Hospital Recruiting
London, United Kingdom, NW1 2PG
Contact: Prof Marie Scully    0207 679 6428   
Contact: I Obu    0207 679 6428   
Sponsors and Collaborators
University College, London

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Responsible Party: University College, London Identifier: NCT03832881    
Other Study ID Numbers: 08/0264
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases