Study of Short-Term Apixaban Treatment to Improve Arteriovenous Fistula Maturation in Adults with End-Stage Renal Disease Undergoing Hemodialysis Access Surgery

What this Trial Is About

End-stage renal disease ESRD is a serious global health issue where patients often need hemodialysis using an arteriovenous fistula AVF for vascular access. AVFs are preferred due to longer use, fewer infections, and lower death rates compared to other options. However, many AVFs fail early because they do not mature properly, which happens in 20-40% of cases, making them unusable for dialysis. This research evaluates whether short-term use of apixaban, a blood thinner given during the critical 6-week maturation period after AVF creation, can improve fistula maturation rates without causing significant bleeding problems. The study compares two groups of adult ESRD patients undergoing primary upper arm AVF creation. One group receives apixaban 2.5 mg twice daily for 6 weeks starting after surgery, while the other group receives a matching placebo. Both groups receive standard intraoperative heparin during surgery but no study drug until 24 hours after surgery. Patients are followed for 6 months, with key assessments at 6 weeks, 3 months, and 6 months, including ultrasound measurements of vein size and blood flow, clinical exams, and recording dialysis use. Participants will undergo screening, surgery, and regular follow-up visits for clinical exams, ultrasound scans, lab tests, and monitoring for side effects like bleeding or hematoma. Researchers will measure fistula maturation based on size, blood flow, and usability for dialysis at 6 weeks, along with longer-term patency and complications. Compliance with study drug is checked by pill counts. Safety is overseen by a monitoring board, and data will be analyzed to see if apixaban improves AVF success compared to placebo.

Effect of Apiban Therapy on AVF Maturation in ESRD Patients