TTP - Thrombotic Thrombocytopenic PurpuraNCT03832881
The United Kingdom Thrombotic Thrombocytopenic Purpura Registry (UK TTP Registry)
An observational study of TTP - Thrombotic Thrombocytopenic Purpura, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TTP - Thrombotic Thrombocytopenic Purpura
- What is being tested?
- ADAMTS13, VWF assay
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with cancer or transplant associated MAHA will not be included.
- Patients not wishing to be involved with the registry.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London, NW1 2PG
Prof Marie Scully, 0207 679 6428, uclh.ttp@nhs.net
I Obu, 0207 679 6428, uclh.ttp@nhs.net
About this study
Official title: 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.
Read the 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.
- Being tested
- ADAMTS13, VWF assay
- Medical subject headings
- Purpura, Thrombotic Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAMTS13, VWF assayDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
TTP incidence
Number of TTP cases in the UK each year
Measured: At study completion, approximately in 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study startJan 2009
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TTP - Thrombotic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832881
- Sponsor's protocol ID
- 08/0264
- Status last verified
- Feb 2019
- First submitted
- 11 Jan 2019
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The United Kingdom Thrombotic Thrombocytopenic Purpura Registry
- ClinicalTrials.gov ID
- NCT03832881
- Acronym / sponsor ID
- 08/0264
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients with cancer or transplant associated MAHA will not be included.
- Patients not wishing to be involved with the registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAMTS13, VWF assay | Diagnostic test | – |
Primary outcome
TTP incidence
Time frame: At study completion, approximately in 2023
Number of TTP cases in the UK each year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TTP - Thrombotic Thrombocytopenic Purpura, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I Obu (0207 679 6428, uclh.ttp@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TTP incidence (time frame: At study completion, approximately in 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.