Clinical Trial

Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Aquablation

Study acronym: TXA-AQ
Not Yet Recruiting Phase 4
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Record status
This record was last updated November 29, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
Summary
This study aims to find out if tranexamic acid (TXA), a medication, works to decrease blood loss during a specific surgery called Aquablation therapy, which is a treatment for men with Benign Prostatic Hyperplasia (BPH). BPH is a common condition in men over the age of 45 that involves enlargement of the prostate gland and can lead to problems or discomfort with urination. The main goal of this research is to see if TXA can help reduce the amount of blood loss during surgery compared to not using the drug. This is important because losing less blood during surgery can help patients recover faster and more safely. Researchers will monitor the safety of TXA and its effects on other outcomes, like the length of hospital stay and any possible changes in blood tests that check how well blood clots. Participants in this study will: * Be males diagnosed with BPH who are already scheduled to undergo Aquablation therapy. * Be randomly assigned to either receive TXA or a placebo (a look-alike substance that contains no drug) right before their surgery. * Not know which treatment they are receiving to make sure the results are unbiased. Researchers hope to engage participants who meet the health criteria of the study. They will be carefully monitored before, during, and after the surgery for any health changes, and their blood loss during surgery will be measured. This study does not require any additional time commitment outside of the standard surgical process, and all treatments will be provided at no additional cost to the participants. The researchers will ensure that all participants understand the procedure and support their safety throughout the research.
Trial Details
NCT Number NCT06710327
Lead Sponsor Kaiser Permanente
Conditions Benign Prostatic Hyperplasia
Enrollment 56 participants
Start Date 2025-01
Primary Completion 2025-07 (estimated)
Study Completion 2025-08 (estimated)
Updated on ClinicalTrials.gov 2024-11-29