Why the study?
Previous clinical trials have addressed that rivaroxaban is effective for PE, and this study aims to systematically assess its efficacy and safety.
Does rivaroxaban reduce all-cause mortality and major bleeding in patients with pulmonary embolism?
Does rivaroxaban reduce all-cause mortality and major bleeding in patients with pulmonary embolism?
This study protocol outlines a systematic review and meta-analysis to evaluate the efficacy and safety of rivaroxaban for the treatment of pulmonary embolism.
Protocol outlines systematic assessment of rivaroxaban for PE; leaves open updated efficacy and safety evidence until results published.
BACKGROUND: Previous clinical trials have addressed that rivaroxaban is effective for the treatment of patients with pulmonary embolism (PE). This study will systematically assess its efficacy and safety for PE. METHODS: We will carry out this study by searching the following electronic databases from inception to March 1, 2019 without language restrictions: Cochrane Library, EMBASE, PUBMED, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. In addition, we will also search clinical trial registries, dissertations, and conference abstracts to avoid any missing potential studies. All randomized controlled trials of rivaroxaban for patients with PE will be fully considered. Two researchers will independently perform literature selection, data collection, and methodological quality assessment. If it is appropriate, outcome data will be pooled by using a fixed-effect model or random-effect model, and meta-analysis will be considered for operation. RESULTS: All efficacy and safety of rivaroxaban for PE will be assessed through all primary and secondary outcomes. The primary outcomes are all-cause mortality and major bleeding. The secondary outcomes are recurrent venous thromboembolism, duration of hospital stay, quality of life, patient satisfaction, and adverse events. CONCLUSION: The findings of this study will summarize updated evidence on the efficacy and safety of rivaroxaban for patients with PE. ETHICS AND DISSEMINATION: It is not necessary to inquire ethical approval for this study, because it will not analyze any individual patient data. The results of this study will be published through peer-reviewed journals. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019126095.
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Jia et al. (2019) studied this question.
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