Epidemiology of Thrombotic Thrombocytopenia Syndrome in Integrated Health-care Database in England

COVID-19 Clinical Trial

Official title:

Epidemiology of Thrombotic Thrombocytopenia Syndrome in Integrated Health-care Database in England.Secondary Data Analysis Using a Cohort Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222750
• Other study ID #: D8111R00011
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: November 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background/Rationale: A rare syndrome of thrombosis associated with low platelets has been reported in a few cases of recent exposure to COVID-19 vaccine. Medicines & Healthcare products Regulatory Agency (MHRA) had requested for all cases of thrombosis or thrombocytopenia occurring within 28 days of coronavirus vaccine to be reported via the online yellow card system. This syndrome seems to be affecting patients of all ages and both genders; at present there is no clear signal of risk factors. Up to and including 14 April 2021, the MHRA had received 168 United Kingdom (UK) reports of thrombo-embolic events with concurrent low levels of platelets following the use of the COVID-19 Vaccine AstraZeneca. The United Kingdom (UK) is uniquely placed to study this area because of its registration-based primary care system, and a unique identifier number links primary care to secondary care data. Additionally, vaccination is well advanced, maximising population wide vaccine exposure.

Objectives and Hypotheses: Estimate event rates and describe characteristics of patients with a record for thrombotic thrombocytopenia syndrome, thromboembolism or thrombocytopenia, in the general population of England.

Methods:

Study design: Secondary data analysis using a cohort design. Data Source(s): This is a retrospective cohort study using linked secondary databases in England accessed through the NHS Digital Trusted Research Environment (TRE). The primary care data will be linked with vaccination, primary care data, hospitalization, COVID-19 test results, mortality data at the national level for capture of key study variables. This integrated digital health system will also include other linkages such as the Oxford-Royal College of General Practitioners sentinel network; ORCHID.

Study Population: All patients, with our population of interest in England who are present in the integrated health records of NHS Digital TRE and/or the Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) database at the start of each study period.

Variables: Demographic, socioeconomic, clinical descriptors and risk factors for thrombosis and/or thrombocytopenia; COVID-19 vaccines.

Statistical Analysis: The event rates with 95% CIs will be calculated by dividing the number of events with person-time at risk per 100,000 person-years. Further, event count and event rates will be evaluated in a relationship with COVID-19 vaccination date.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41200246
• Est. completion date: May 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients, with a primary focus from age 16 years old and older, in England who are present in the integrated database at the start of each study period.

Exclusion Criteria:

• Less than 12 months of prior history at start of each respective study period.

Related Conditions & MeSH terms

• COVID-19
• Thrombocytopenia

Intervention

Other:
• Pre-COVID-19
Pre-COVID-19
• COVID-19
COVID-19
• COVID-19 vaccination roll-out
COVID-19 vaccination roll-out

Locations

Country	Name	City	State
United Kingdom	Research Site	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate event rates and describe characteristics of patients with a record for thrombotic thrombocytopenia syndrome, thromboembolism or thrombocytopenia, in the general population of England.	This is to complete studies in NHS Digital and ORCHID data	9 months

External Links

•   CSR Synopsis _Redacted (002).pdf