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

Introduction Immune 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 Analysis A 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 dissemination Since 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 number CRD42023471315. Strengths and limitations of this study ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study is supported by the National Natural Science Foundation of China (grant numbers 81673968) ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Since 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. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All the data generated in this study can be provided according to the reasonable requirements of the author. All the data generated in this study are included in the manuscript and are available online.