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

NCT03832881 | Unknown

• 1 other identifier: 08/0264
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

TTP - Thrombotic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

• TTP incidence

  Number of TTP cases in the UK each year

  At study completion, approximately in 2023

Interventions

ADAMTS13, VWF assay DIAGNOSTIC_TEST

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with cancer or transplant associated MAHA will not be included.
• Patients not wishing to be involved with the registry.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, NW1 2PG, United Kingdom

RECRUITING

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.)

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Thrombophilia; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Central Study Contacts

I Obu

CONTACT

0207 679 6428; uclh.ttp@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: February 6, 2019
• Study Start: January 1, 2009
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

GB (1)