All-cause mortality after major gastrointestinal bleeding among patients receiving direct oral anticoagulants: a protocol for a systematic review and meta-analysis

Syst Rev. 2022 Dec 13;11(1):269. doi: 10.1186/s13643-022-02146-5.

Abstract

Background: Gastrointestinal (GI) bleeding represents the single most frequent site of anticoagulant-related bleeding. Adverse outcomes after major GI bleeding including mortality are not well characterized and, as a result, may be underappreciated in clinical practice. We aim to conduct a systematic review and meta-analysis of the risk for 30-day all-cause mortality after major GI bleeding among patients receiving DOACs.

Methods: Electronic databases including MEDLINE, EMBASE, and Cochrane CENTRAL will be systematically searched to identify randomized controlled trials and prospective and retrospective cohort studies reporting 30-day all-cause mortality in adults with DOAC-related major GI bleeding. At least two investigators will independently perform study selection, risk of bias assessment, and data extraction. The proportion of deaths following a major GI event relative to the number of major GI bleeding events will be calculated for each individual study, and results across studies will be pooled using random-effects meta-analysis. We will assess risk of bias using criteria proposed by the GRADE group for prognostic studies.

Discussion: The findings of this systematic review and meta-analysis will provide clinicians and patients with estimates of mortality after the most common major bleeding event to support shared decision making about anticoagulation management.

Trial registration: PROSPERO CRD42022295815.

Keywords: Anticoagulation; Bleeding; Direct oral anticoagulants; Mortality.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Anticoagulants* / adverse effects
  • Gastrointestinal Hemorrhage* / chemically induced
  • Gastrointestinal Hemorrhage* / drug therapy
  • Humans
  • Meta-Analysis as Topic
  • Prospective Studies
  • Retrospective Studies
  • Systematic Reviews as Topic

Substances

  • Anticoagulants

Grants and funding