Tranexamic acid for epistaxis in hereditary hemorrhagic telangiectasia patients: a European cross‐over controlled trial in a rare disease. (29th July 2014)

• Record Type: Journal Article
• Authors: Gaillard, S.; Dupuis‐Girod, S.; Boutitie, F.; Rivière, S.; Morinière, S.; Hatron, P.‐Y.; Manfredi, G.; Kaminsky, P.; Capitaine, A.‐L.; Roy, P.; Gueyffier, F.; Plauchu, H.; The ATERO Study Group
• Is Part Of: Journal of thrombosis and haemostasis. Volume 12:Number 9(2014:Sep.)
• Page Start: 1494
• Page End: 1502
• Publication Date: 2014-07-29
• Subjects: Thrombosis -- Periodicals; Hemostasis -- Periodicals; Blood coagulation disorders -- Periodicals; 616.1
• DOI: 10.1111/jth.12654
• Languages: English
• ISSNs: 1538-7933

Abstract

<abstract abstract-type="main" id="jth12654-abs-0001"> <title>Summary</title> <sec id="jth12654-sec-0001" sec-type="section"> <title>Background</title> <p>Hereditary hemorrhagic telangiectasia (HHT) is a genetic disorder associated with abnormal angiogenesis and disabling epistaxis. Tranexamic acid (TA) has been widely used in the treatment of these severe bleeds but with no properly designed trial.</p> </sec> <sec id="jth12654-sec-0002" sec-type="section"> <title>Objectives</title> <p>To demonstrate the efficacy of TA in epistaxis in HHT patients and to explore its safety of use.</p> </sec> <sec id="jth12654-sec-0003" sec-type="section"> <title>Patients/Methods</title> <p>A randomized, placebo‐controlled, double‐blind, cross‐over trial was conducted. Participants were randomized to receive TA (3 g a day) then placebo or the opposite sequence. The main analysis compared intra‐individual mean duration of epistaxis under TA vs. placebo on a log scale. The primary outcome was the mean duration of epistaxis per month, assessed with specific grids to be completed by participants. The number of epistaxis episodes was recorded as a secondary outcome.</p> </sec> <sec id="jth12654-sec-0004" sec-type="section"> <title>Results</title> <p>A total of 118 randomized patients contributed to the statistical analysis. The mean duration of epistaxis per month was significantly shorter with TA than placebo (0.19 on the log scale; SD = 0.07; <italic>P</italic> = 0.005), corresponding to a decrease of 17.3% (15.7 min) in the duration of epistaxis per month (CI 95%, 5.5–27.6). The median number of epistaxis episodes per month was 22.1 episodes in the placebo arm vs. 23.3 episodes in the TA arm. No thrombophlebitis was observed.</p> </sec> <sec id="jth12654-sec-0005" sec-type="section"> <title>Conclusions</title> <p>In the ATERO study, we demonstrated a significant decrease in the duration of epistaxis in HHT patients taking TA. No safety issues were recorded in our cohort of patients.</p> </sec> </abstract>