BRACKETS Pilot Trial to Test Tranexamic Acid and Desmopressin for Reducing Bleeding in Adults with Severe Kidney Disease Undergoing Noncardiac Surgery

What this Trial Is About

Researchers are evaluating the use of prophylactic preoperative tranexamic acid TXA and desmopressin in patients with advanced kidney disease undergoing noncardiac surgery. This pilot study aims to assess the feasibility and design of a larger trial, provide preliminary safety and efficacy data, and gather pharmacokinetic information to help select appropriate dosages. The study addresses a gap since patients with severe kidney disease have been excluded from large trials despite bleeding risks during surgery. Participants will be randomly assigned to receive intravenous TXA, desmopressin, both, or placebos shortly before surgery. TXA dosing varies based on kidney function and dialysis status, with either 1000 mg or 500 mg infused over 10 minutes. Desmopressin is given as a 20 mcg infusion over 30 minutes. Placebo infusions use saline solutions matching the timing and volume of the active drugs. Treatment is administered within 20 minutes before the skin incision. During the study, researchers will monitor recruitment rates, drug administration timing, and conduct a 30-day follow-up after surgery. They will assess bleeding outcomes, blood transfusions, surgical complications, cardiovascular events, kidney function changes, and other safety measures. The total observation period includes the day of surgery and 30 days afterward, tracking hospital stay duration and postoperative recovery indicators to evaluate the interventions impact comprehensively.

Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial