ASSOCIATION BETWEEN THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS) OR THROMBOEMBOLIC EVENTS, AND COVID-19 VACCINES

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46886
• EU PAS number:
  EUPAS44469
• Study ID:
  46886
• Official title and acronym:
  ASSOCIATION BETWEEN THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS) OR THROMBOEMBOLIC EVENTS, AND COVID-19 VACCINES
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Netherlands

  Spain

  United Kingdom

  United States
• Study description:
  Aim/s: To quantify the association between the administration of a COVID-19 vaccine and the occurrence of TTS-1a/ thromboembolic events (TE)-2a. To quantify the comparative association of developing TTS-1b/TE-2b between the administration of different COVID-19 vaccine brands. 3) To study the association between potential risk factors and TTS/TE, 4) To characterize the treatments used in patients with TTS/TE. METHODS A multi-nation network cohort study with 8 databases across six countries. Propensity score (PS) matching cohort will be used to estimate the incidence rate of getting TTS/TE for Objective 1a-2b. Negative control outcomes will be also used to assess residual confounding. LASSO regression will be used to identify risk factors of post-vaccination TTS/TE (3). For each risk factors identified, another logistic regression will be used to estimate the size of risk and its multiplicative interaction effect with COVID-19 vaccine. Data visualisation tools will be used to describe the treatment pathways among medications in patients diagnosed with TTS/TE (4).
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

IQVIA

United Kingdom

Parc Salut Spain, IQVIA Germany, SIDIAP spain, EMC Netherlands, UniOxf UK

Networks

Pharmacoepidemiology Research Group

Study timelines

Date when funding contract was signed

Planned: 28/09/2021

Actual: 28/09/2021

Study start date

Planned: 01/12/2020

Actual: 01/12/2020

Date of final study report

Planned: 28/02/2022

Actual: 30/03/2022

Sources of funding

EMA

Study protocol

Initial protocol

TTSCOVID19 vaccine protocol V2

Updated protocol

fullProtocol

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable