Abstract
Data sourcesCochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, a regularly updated database informed by trials identified within electronic databases including MEDLINE. Further defined searches were undertaken in PubMed, Embase, The Cochrane Library, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform. Additional hand searching of relevant journals and books of conference proceedings was undertaken.Study selectionRandomised and quasi-randomised controlled trials in people of all ages with haemophilia or VWD undergoing oral or dental procedures using antifibrinolytic agents (tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)) to prevent perioperative bleeding compared to no intervention with or without placebo.Data extraction and synthesisTwo authors independently assessed identified publications for inclusion based on defined selection criteria. The two authors performed data extraction and risk of bias assessments using standardised forms and the Cochrane risk of bias tools. A third author, deemed to have particular subject expertise, verified eligibility of inclusion.ResultsOne randomised, double-blinded placebo controlled trial and one quasi-randomised trial were included. A total of 59 participants with haemophilia undergoing dental extraction were involved. Both trials evidenced a notable reduction in post-operative bleeding following dental extraction when either TXA or EACA were used, in addition to routine preoperative factor replacement, when compared to placebo. The number of post-operative bleeds, amount of blood loss and the need for additional clotting factors were reduced in the groups receiving antifibrinolytic therapy. No eligible trials in people with VWD were identified.ConclusionsLow quality evidence exists to support the use of adjuvant antifibrinolytic therapy to reduce perioperative bleeding in patients with haemophilia undergoing dental extraction. The limited number of trials identified (N=2), minimal sample size (N=28, N=31) and historic nature of the studies, originating from the 1970s, in addition to study heterogeneity and subsequent selection bias results in a low quality evidence grade for recommending adjuvant antifibrinolytic therapy. There is no clear indication to alter current practice utilising antifibrinolytic therapy to manage patients with haemophilia undergoing dental surgery in accordance with internationally accepted guidelines. However, further research with standardised study deigns would be welcomed in order to enhance the evidence base in the management of people with haemophilia and VWD.
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