Thrombosis with thrombocytopenia syndrome (TTS) and vaccine-induced immune thrombocytopenia and thrombosis (VITT): Brighton Collaboration case definitions and guidelines for data collection, analysis, and presentation of immunisation safety data.
Vaccine
; 42(7): 1799-1811, 2024 Mar 07.
Article
em En
| MEDLINE
| ID: mdl-38302339
ABSTRACT
This is a revision of the online November 2021 Brighton thrombosis with thrombocytopenia syndrome (TTS) case definition and a new Brighton Collaboration case definition for vaccine-induced immune thrombocytopenia and thrombosis (VITT). These case definitions are intended for use in clinical trials and post-licensure pharmacovigilance activities to facilitate safety data comparability across multiple settings. They are not intended to guide clinical management. The case definitions were developed by a group of subject matter and Brighton Collaboration process experts as part of the Coalition for Epidemic Preparedness Innovations (CEPI)-funded Safety Platform for Evaluation of vACcines (SPEAC). The case definitions, each with defined levels of diagnostic certainty, are based on relevant published evidence and expert consensus and are accompanied by specific guidelines for TTS and VITT data collection and analysis. The document underwent peer review by a reference group of vaccine safety stakeholders and haematology experts to ensure case definition useability, applicability and scientific integrity.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Trombocitopenia
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Trombose
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Vacinas
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Púrpura Trombocitopênica Idiopática
Tipo de estudo:
Guideline
Limite:
Humans
Idioma:
En
Revista:
Vaccine
Ano de publicação:
2024
Tipo de documento:
Article