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

NCT06710327 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: KPSC IRB 056236KPSC IRB 056263
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH; TXA; Aquablation; Benign Prostatic Hyperplasia; Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured preoperatively and postoperatively, within 2 hours of surgery completion

Secondary Outcomes (5)

• Rate of Perioperative Complications Associated with Tranexamic Acid

  From initiation of surgery to post-operative follow up, up to 60 days post-surgery.

• Length of Hospital Stay Post-Aquablation Therapy

  From time of surgery to hospital discharge, typically within 1 day post-surgery

• Change in ProThrombin Time (PT) Following Tranexamic Acid Administration

  Lab values measured preoperatively and within 2 hours post-surgery.

• Change in activated partial thromboplastin time (aPTT) Following Tranexamic Acid Administration

  Lab values measured preoperatively and within 2 hours post-surgery.

• Change in activated fibrinogen level Following Tranexamic Acid Administration

  Lab values measured preoperatively and within 2 hours post-surgery.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

TXA Administration

EXPERIMENTAL

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.

Drug: Tranexamic Acid (IV)

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.

Also known as: TXA, Cyclokapron

TXA Administration

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.

Also known as: normal saline, NS

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Christopher F Tenggardjaja, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher F Tenggardjaja, MD

CONTACT

323-783-0397; Christopher.Tenggardjaja@kp.org

Eric J Robinson, MD

CONTACT

323-387-6121; Eric.J.Robinson@kp.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: placebo-controlled

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 29, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)