Association of the Risk for Thrombotic Thrombocytopenia Syndrome and Exposure To COVID-19 Vaccines (ATTEST)
An Assessment of a Relationship Between the Exposure to COVID-19 Vaccines and Risk of Thrombotic Thrombocytopenia Syndrome ATTEST Study (Association of the Risk for Thrombotic Thrombocytopenia Syndrome and Exposure To COVID-19 Vaccines)
Background/Rationale: A very rare syndrome of thrombosis associated with low platelets has been reported in a few cases of recent exposure to COVID-19 vaccine. This thrombotic thrombocytopenia syndrome seems to be affecting patients of all ages and both genders; at present there is no clear signal of risk factors.
Objectives: To evaluate an association between COVID-19 vaccine exposure and thromboembolic events occurring with thrombocytopenia (thrombotic thrombocytopenia syndrome; TTS).
Study design: Two primary study designs will be considered, a case control study and a self-controlled case series (SCCS). A cohort analysis will be considered, in addition or as an alternative to either of the primary study designs, pending feasibility assessment of the follow-up time.
Data Source(s): Data for the study will be accessed through the NHS Digital Trusted Research Environment (TRE), providing national data coverage. Primary care data will be linked with vaccination, hospitalization, COVID-19 test results, mortality data. Initial exploratory analyses will be conducted using the Oxford-Royal College of General Practitioners sentinel network; ORCHID network database (N>15million).
Subjects of interest are patients who have received a COVID-19 vaccine. However, investigators will require access to data from all subjects in the databases.
Statistical Analysis: The study period will start on December 02, 2020, when the COVID-19 vaccine was first approved in the UK and will end at the end of data availability.
For the case-control design, all cases of TTS will be matched with control using risk-set matching. A case or matched control will be considered exposed if a COVID-19 vaccination will be within risk interval prior to the diagnosis date of the matched case.
For the SCCS, estimates of relative incidence (RI), in all risk intervals will be reported.
For the retrospective cohort design, the incidence of TTS after receiving COVID-19 vaccine will be estimated and investigators will compare this incidence with that occurring in an unvaccinated comparator group about levels of infection across the whole population.
Variables: Demographic, socioeconomic descriptors, clinical diagnosis, vaccines, potential confounders, thrombotic phenomena, COVID-19 infection, and other characteristics as applicable.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oxford, United Kingdom, OX12JD
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- A minimum of 12 months medical history prior to the start of the study period
Exclusion Criteria:
- Less than 12 moths medical history prior to the start of the study period
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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COVID-19
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COVID-19 period
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Pre-COVID-19
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Pre-COVID-19 period
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COVID-19 vaccination roll-out
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COVID-19 vaccination roll-out period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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thrombotic thrombocytopenia syndrome; TTS
Time Frame: 9 months
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This is to complete studies in NHS Digital and ORCHID data
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9 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- D8111R00010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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