Tranexamic Acid for Enlarged Prostate
(TXA-AQ Trial)

Recruiting in Palo Alto (17 mi)

Overseen byChristopher Tenggardjaja

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Kaiser Permanente

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Men over 45 with Benign Prostatic Hyperplasia (BPH) scheduled for Aquablation therapy can join. Participants must meet health criteria and will be randomly assigned to receive either Tranexamic Acid or a placebo without knowing which one they get.

Inclusion Criteria

I have noticeable symptoms from an enlarged prostate.

I am a man scheduled for Aquablation therapy for BPH.

I am 45 years old or older.

Exclusion Criteria

Required extended preoperative resting period

Belonging to vulnerable populations such as prisoners (who are not treated in our clinics)

I have been diagnosed with prostate cancer.

+6 more

Participant Groups

The trial is testing if Tranexamic Acid (TXA), given intravenously, reduces blood loss during Aquablation surgery compared to a placebo. The study also monitors TXA's safety and its impact on recovery indicators like hospital stay duration.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TXA AdministrationExperimental Treatment1 Intervention

Participants receive tranexamic acid (TXA) preoperatively via intravenous (IV) administration. The dose consists of 1g of TXA delivered in a single IV push immediately prior to the Aquablation therapy. TXA acts as an antifibrinolytic agent, preventing excessive blood loss by stabilizing the formation of blood clots during surgery. This intervention aims to assess TXA's efficacy in reducing perioperative blood loss compared to placebo, with all other aspects of the surgical procedure and postoperative care remaining standardized across both study arms.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive an intravenous (IV) administration of a placebo prior to their Aquablation procedure. This placebo is a saline solution that looks identical to the tranexamic acid (TXA) used in the Intervention Group but contains no active medication. The placebo is given to mimic the administration of TXA to ensure that the study conditions are the same for both groups, except for the active treatment. All other aspects of the surgical procedure and postoperative care remaining standardized across both study arms.