Hemostasis after percutaneous transfemoral access: A protocol for systematic review

Abstract

Background: Access site hemostasis after percutaneous procedures done in the catheterization laboratory still needs to be better studied in relation to such aspects as the different results achieved with different hemostasis strategies, the impact of different introducer sheath sizes, and arterial versus venous access. The objective of this review is to synthesize the available scientific evidence regarding different techniques for hemostasis of femoral access sites after percutaneous diagnostic and therapeutic procedures. Methods:This review is being reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). The primary outcomes will include the following vascular complications: hematoma, pseudoaneurysm, bleeding, minor, and major vascular complications. The secondary outcomes will include the following: time to hemostasis, repetition of manual compression, and device failure. A structured strategy will be used to search the PubMed/ MEDLINE, Embase, CINAHL, and CENTRAL databases. In addition, a handsearch of the reference lists of selected studies will be conducted. The ERIC research database will be queried for the gray literature and ClinicalTrials.gov, for potential results not yet published in indexed journals. Two reviewers will independently screen citations and abstracts, identify full-text articles for inclusion, extract data, and appraise the quality and risk of bias of included studies. If possible, a meta-analysis will be carried out. All estimations will be made using Review Manager 5.3. Statistical heterogeneity will be assessed by considering the I2 proxy, accompanied with qualitative indicators such as differences in procedures, interventions, and outcomes among the studies. If synthesis proves inappropriate, a narrative review will be undertaken. Results: This protocol adheres to the PRISMA-P guideline to ensure clarity and completeness of reporting at all phases of the systematic review. Conclusion: This study will provide synthesized information on different methods used to achieve hemostasis after femoral access. Ethics and dissemination: Ethical approval number CAAE 19713219700005327. The results of the systematic review will be disseminated via publication in a peer-reviewed journal and through conference presentations. Systematic review registration: PROSPERO CRD42019140794. Abbreviations: CENTRAL = Cochrane Central Register of Controlled Trials, CIs = confidence intervals, CINAHL = Cumulative Index to Nursing and Allied Health Literature, ERIC = Education Resources Information Center, GRADE = Grading of Recommendations, Assessment, Development and Evaluation, MEDLINE = Medical Literature Analysis and Retrieval System Online, PRISMA = Preferred Reporting Items for Systematic Reviews and Meta-Analyses, PRISMA-P = Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols.