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

This clinical study is investigating whether a medication called tranexamic acid (TXA) can help reduce blood loss during a type of prostate surgery known as Aquablation therapy. This therapy is used to treat Benign Prostatic Hyperplasia (BPH), a common condition in older men that results in the enlargement of the prostate gland which can cause difficulty with urination.

Purpose of the Study:

The primary purpose of this research is to determine if TXA makes this surgery safer by decreasing the amount of blood lost during the procedure. Reducing blood loss during surgery is beneficial because it can lead to quicker recovery times and reduce the likelihood of complications. The study will also look at other important factors such as the overall safety of using TXA, its effect on the length of time participants stay in the hospital after surgery, and whether it causes any significant changes in blood clotting tests.

How the Research Will Happen:

Participants in the study will be men diagnosed with BPH who are planning to undergo Aquablation therapy. They will be randomly placed into one of two groups:

One group will receive TXA through an IV right before their surgery. The other group will receive a placebo, which is a substance that looks like the medication but contains no active drug, administered in the same way.

This setup ensures that neither the participants nor the health care providers know who receives the TXA and who receives the placebo, helping to maintain objectivity in the results.

What Participants Will Do:

Participants will visit the hospital as they normally would for their scheduled surgery. Before the surgery, they will receive either TXA or the placebo. The procedure itself and the immediate recovery process do not change. Researchers will collect information about how much blood participants lose during surgery and monitor their recovery closely.

The number of visits and what each participant needs to do during the study remains the same as what would happen during typical Aquablation therapy. Besides receiving the TXA or placebo, there are no additional procedures or drugs involved.

Safety Measures:

Study researchers are committed to participant safety. Participants will be closely monitored throughout the surgery and their recovery. The research team will watch for any side effects or reactions to the medication, especially any signs of blood clotting or allergic reactions, as TXA is known to affect blood clotting. If there are any concerns about a participant's health, they can be quickly addressed by the medical team.

Why This Matters:

For men undergoing Aquablation therapy for BPH, managing blood loss is a major safety concern. If TXA can effectively reduce blood loss without causing other complications, it could improve the outcomes for thousands of men who undergo this surgery every year.

This study will help doctors better understand the benefits and risks of using TXA in this setting, potentially leading to its wider use in similar surgeries to improve patient safety and outcomes.

Inclusion criteria

• Male participants diagnosed with BPH scheduled for Aquablation therapy.
• Aged 45 years or older
• Exhibiting clinically significant symptoms of BPH.

Exclusion criteria

• History of or high risk for thrombosis.
• Presence of preoperative heart or cerebrovascular diseases.
• Renal insufficiency.
• Ongoing anticoagulation therapy.
• Required extended preoperative resting period.
• Diagnosis of prostate cancer.
• Any form of blood coagulation dysfunction.
• Previous use of warfarin or aspirin before the surgery.
• Belonging to vulnerable populations such as prisoners (who are not treated in our clinics).