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Research Showed Prophylactic Tranexamic Acid Lowers Perioperative Bleeding Risk Without Increasing Cardiovascular Risk Across Many Types of General Surgery.
A substudy analysis of the Perioperative Ischemic Evaluation-3 (POISE-3) trial showed that prophylactic tranexamic acid (TXA) significantly lowered the risk of perioperative bleeding without increasing cardiovascular risk for patients undergoing general surgery procedures, according to findings published in JAMA SURGEY.
PHONE-3 Was to Blinded, International, Multicenter, Randomized Clinical Trial That Enrolled 9,535 Patients AGED 45 and Older Underging Nancordiac Surgery. Participants Had Increaded Cardiovascular Risk and Were Expected to Require at Least an Overnight Hospital Stay After Surgery.
For the substudy, MAURA MARCUCCI, MD, MSCand Colleagues Evaluated the Safety and Effficcy of Treatment with Prophylactic Txa (1 G Bolus IV) Compred with placebo at the start and end of surgery.
The Total of 3,260 Patients Underwent to General Surgery Procedure. The Patients’ Mean Age Was 68.6 Years, 53.4% Were Men, and 46.6% Were Women. The Primary Efficacy Endpoint was a composite of life-threatening bleeding, Major Bleeding, or Bleeding into the critical organ. The Primary Safety Endpoint was a composite of myocardial Injury after Nancordiac Surgery, Nonhemorrhagic Stroke, peripheral arterial Thrombosis, or symptletic proximal venous thrombombolism at 30 days.
Reduction in Major Bleeding Across All Surgery Types
The Researchers Found That Prophylactic Txa Significantly Reduced Major Bleeding Events Compred with placebo (8.0% vs 10.5%, respectively; HR, 0.74; 95% CI, 0.59-0.93; P= 0.01). AddiTerally, 11.9% and 12.5% of Patients in the txa and placebo arms, respective, met the primary safety outcome (HR, 0.95; 95% CI, 0.78-1.16; P= 0 .63).
The Findings Also Showed No Significant Interact by Type of Surgery (General Surgery vs Nongeneral Surgery) on the Primary Effficacy (P= 0.81) and Safety (P= 0.37) Outcomes. Across Subtypes of General Surgery, Txa Decreased the Composite Bleeding Outcome in 332 Patients Undergoing Hepatopancobiliary Surgery (HR, 0.55; 95% CI, 0.34-0.91) and 940 Patients Undering Colorectal Surgery (HR, 0.67; 95% CI, 0.45-0.98) . Furthermore, The Researchers Observed in Significant Interaction Across Subtypes of General Surgery (P= 0.68).