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.
Male participants diagnosed with BPH scheduled for Aquablation therapy.
Aged 45 years or older
Exhibiting clinically significant symptoms of BPH.
History of or high risk for thrombosis.
Presence of preoperative heart or cerebrovascular diseases.
Renal insufficiency.
Ongoing anticoagulation therapy.
Parallel
Tranexamic Acid (IV)
DrugThe intervention is administered as a clear, colorless solution infusion. The dosage administered is a 1 gram intravenous (IV) push, delivered immediately before starting the Aquablation therapy. The administration of TXA occurs only once, as a single dose preoperatively.
Placebo
DrugParticipants receive a saline solution, which is a sodium chloride (0.9%) IV infusion, identical in appearance to the TXA solution. The saline is administered as a single 1 gram-equivalent volume intravenous (IV) push, delivered immediately before the Aquablation therapy commences. This singular administration matches the frequency and timing of the TXA intervention to ensure uniformity across both study groups, maintaining the blinding of the study.
Perioperative Hemoglobin Change
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.
Rate of Perioperative Complications Associated with Tranexamic Acid
This measure tracks the incidence of perioperative complications, including but not limited to thromboembolic events, which are potential risks associated with TXA. The frequency of these complications will be compared between patients treated with TXA and those receiving a placebo to understand any increased risks when using TXA in the context of Aquablation therapy.
Length of Hospital Stay Post-Aquablation Therapy
This secondary outcome evaluates whether TXA administration affects the length of postoperative hospital stay compared to placebo. The length of stay is calculated from the time of surgery completion to the time of discharge, aiming to ascertain if TXA can contribute to a faster recovery and shorter hospitalization.
Change in ProThrombin Time (PT) Following Tranexamic Acid Administration
This measure determines if TXA administration has any significant effect on an element of the coagulation, prothrombin time (PT). Serum sample will be collected and analyzed preoperatively and postoperatively to detect any changes that might indicate a heightened risk of clotting or bleeding abnormalities.
Change in activated partial thromboplastin time (aPTT) Following Tranexamic Acid Administration
This measure determines if TXA administration has any significant effect on an element of the coagulation, activated partial thromboplastin time (aPTT). Serum sample will be collected and analyzed preoperatively and postoperatively to detect any changes that might indicate a heightened risk of clotting or bleeding abnormalities.
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