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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Kaiser Permanente
Study ID
NCT06710327
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
MALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tranexamic Acid (IV) — DRUG
    The 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 — DRUG
    Participants 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.

Study Details

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.

Key Dates

Start date
Jan 31, 2025
Status verified
Nov 2024
Primary completion
Jul 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Placebo Comparator: Placebo
    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.
  • Experimental: TXA Administration
    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.

Primary Outcome Measure

Perioperative Hemoglobin Change [ Time Frame: Measured preoperatively and postoperatively, within 2 hours of surgery completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027
Christopher F Tenggardjaja, MD
[email protected]
323-783-0397
Eric J Robinson, MD
[email protected]
323-387-6121
Christopher F Tenggardjaja, MD
Christopher P Filson, MD
Eric J Robinson, MD

Find similar trials in Los Angeles, CA

By research site
Kaiser Permanente Los Angeles Medical Center· Los Angeles, CA

Related Studies