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Randomized Controlled Trial
Tranexamic Acid for Lower GI Hemorrhage: A Randomized Placebo-Controlled Clinical Trial.
- Stephen R Smith, David Murray, Peter G Pockney, Cino Bendinelli, Brian D Draganic, and Rosemary Carroll.
- Department of Colorectal Surgery, John Hunter Hospital, University of Newcastle, Newcastle, New South Wales, Australia.
- Dis. Colon Rectum. 2018 Jan 1; 61 (1): 99-106.
BackgroundLower GI hemorrhage is a common source of morbidity and mortality. Tranexamic acid is an antifibrinolytic that has been shown to reduce blood loss in a variety of clinical conditions. Information regarding the use of tranexamic acid in treating lower GI hemorrhage is lacking.ObjectiveThe aim of this trial was to determine the clinical efficacy of tranexamic acid when used for lower GI hemorrhage.DesignThis was a prospective, double-blind, placebo-controlled, randomized clinical trial.SettingsThe study was conducted at a tertiary referral university hospital in Australia.PatientsConsecutive patients aged >18 years with lower GI hemorrhage requiring hospital admission from November 2011 to January 2014 were screened for trial eligibility (N = 265).InterventionsA total of 100 patients were recruited after exclusions and were randomly assigned 1:1 to either tranexamic acid or placebo.Main Outcome MeasuresThe primary outcome was blood loss as determined by reduction in hemoglobin levels. The secondary outcomes were transfusion rates, transfusion volume, intervention rates for bleeding, length of hospital stay, readmission, and complication rates.ResultsThere was no difference between groups with respect to hemoglobin drop (11 g/L of tranexamic acid vs 13 g/L of placebo; p = 0.9445). There was no difference with respect to transfusion rates (14/49 tranexamic acid vs 16/47 placebo; p = 0.661), mean transfusion volume (1.27 vs 1.93 units; p = 0.355), intervention rates (7/49 vs 13/47; p = 0.134), length of hospital stay (4.67 vs 4.74 d; p = 0.934), readmission, or complication rates. No complications occurred as a direct result of tranexamic acid use.LimitationsA larger multicenter trial may be required to determine whether there are more subtle advantages with tranexamic acid use in some of the secondary outcomes.ConclusionsTranexamic acid does not appear to decrease blood loss or improve clinical outcomes in patients presenting with lower GI hemorrhage in the context of this trial. see Video Abstract at http://links.lww.com/DCR/A453.
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