An Assessment of a relationship between the exposure to COVID-19 vaccines and risk of thrombotic thrombocytopenia syndrome (Association of the risk for Thrombotic Thrombocytopenia Syndrome and Exposure To COVID-19 vaccines) - ATTEST study

Study identification

• EU PAS number:
  EUPAS43687
• Study ID:
  49257
• Official title and acronym:
  An Assessment of a relationship between the exposure to COVID-19 vaccines and risk of thrombotic thrombocytopenia syndrome (Association of the risk for Thrombotic Thrombocytopenia Syndrome and Exposure To COVID-19 vaccines) - ATTEST study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  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 people who have received a COVID-19 vaccine. However, we will require access to data from all subjects in the databases.
• Study status:
  Finalised

Research institutions and networks

Institutions

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford

United Kingdom

Study timelines

Date when funding contract was signed

Actual:14/06/2021

Study start date

Planned:15/03/2023

Actual:01/03/2022

Data analysis start date

Planned:03/04/2023

Actual:07/06/2023

Date of final study report

Planned:30/11/2023

Actual:15/05/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

D8111R00010