Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Aquablation for Benign Prostatic Hyperplasia: a Randomized Controlled Trial (TXA-AQ)

NCT06710327 Phase 4 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Kaiser Permanente
Phase	Phase 4
Status	NOT_YET_RECRUITING
Enrolment	56
Start date	2025-01
Completion	2025-08

Conditions

• Benign Prostatic Hyperplasia

Interventions

• Tranexamic Acid (IV)
• Placebo

Primary outcomes

• Perioperative Hemoglobin Change — Measured preoperatively and postoperatively, within 2 hours of surgery completion
  The primary outcome measure is the efficacy of tranexamic acid (TXA) in decreasing the amount of hemoglobin lost during Aquablation therapy compared to placebo. This will be quantitatively assessed by measuring the hemoglobin levels in patients' blood samples collected immediately before and after the procedure. The change in hemoglobin levels will be compared between the TXA-treated group and the placebo group to determine if TXA administration results in a significantly smaller decrease in hemoglobin, indicating less blood loss.

Countries

United States