The impact of COVID-19 vaccines on patients with immune thrombocytopenic purpura: A protocol for a systematic review and meta-analysis

Abstract

AbstractIntroductionImmune thrombocytopenic purpura (ITP) is characterized by a decrease in platelet counts and can be triggered by various factors, such as viral infections and vaccinations. Concerns have emerged regarding potential links between the vaccines for COVID-19 and the worsening of ITP. This systematic review aims to comprehensively assess the impact of COVID-19 vaccines on patients with ITP, including associated risks and outcomes.Methods and AnalysisA thorough search will be conducted across multiple electronic databases, including PubMed, Web of Science, EMBASE, Cochrane Library, CNKI, Wan Fang, VIP, and CBM, to identify pertinent studies. This study will encompass randomized controlled trials, cohort studies, case-control studies, and case series that assess the effects of COVID-19 vaccines on individuals with ITP. The primary outcome will center on alterations in platelet count, while secondary outcomes will encompass the occurrence of thromboembolic events, bleeding complications, recurrence rate of ITP, impact of ITP exacerbation, and adverse events. The data will be synthesized and subjected to meta-analysis using Review Manager Software (RevMan) V.5.3. Additionally, subgroup analyses will be conducted to investigate potential sources of heterogeneity.Ethics and disseminationSince this study involves the analysis of previously published data, ethical approval is not required. The findings will be disseminated through publication in a peer-reviewed journal and presentation at relevant scientific conferences.PROSPERO registration numberCRD42023471315.Strengths and limitations of this studyAssessing the overall impact of COVID-19 vaccines on patients with ITPIncorporating a variety of study types to perform a thorough analysisImplementing a standardized methodology to evaluate and mitigate bias in the studies includedPossible restrictions in data accessibility and variations in heterogeneity among the studies consideredThe effects of different types of COVID-19 vaccines on patients with ITP may differ, leading to potential disparities in the outcomes.