Tranexamic Acid for Enlarged Prostate

(TXA-AQ Trial)

Overseen By Eric J Robinson, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Kaiser Permanente

Must not be taking: Anticoagulants, Aspirin

Disqualifiers: Thrombosis, Heart disease, Renal insufficiency, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

56 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on ongoing anticoagulation therapy or have used warfarin or aspirin before the surgery.

What data supports the effectiveness of the drug Tranexamic Acid for treating an enlarged prostate?

Research shows that Tranexamic Acid (TXA) can help reduce bleeding in prostate surgeries, as it has been effective in managing bleeding in other types of surgeries like cardiac and orthopedic procedures. However, its specific effectiveness and safety for enlarged prostate treatments are not fully established yet. ^{1 2 3 4 5}

How does the drug tranexamic acid differ from other treatments for enlarged prostate?

Tranexamic acid is unique for treating an enlarged prostate because it is primarily used to reduce bleeding, unlike other treatments that focus on shrinking the prostate or relieving urinary symptoms. It works by preventing the breakdown of blood clots, which can help manage bleeding during prostate surgeries or in cases of refractory bleeding. ^{1 2 3 4 5}

Research Team

Christopher Tenggardjaja

Principal Investigator

Kaiser Permanente

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive either tranexamic acid (TXA) or placebo intravenously before surgery

Immediate pre-surgery

1 visit (in-person)

Surgery

Participants undergo Aquablation therapy for BPH with monitoring of blood loss

During surgery

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for safety, blood loss, and recovery post-surgery

Up to 60 days post-surgery

Follow-up visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tranexamic Acid

Trial Overview 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.

Participant Groups

Group I: TXA Administration Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Intraprostatic injection of tranexamic acid to control refractory bleeding while maintaining therapeutic anticoagulation. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Does Not Improve Outcomes of Holmium Laser Enucleation of the Prostate: A Prospective Randomized Controlled Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analyses of tranexamic acid use for bleeding reduction in prostate surgery. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of tranexamic acid administration in reducing bleeding in benign prostate hyperplasia patients underwent open prostatectomy: A double-blind randomized clinical trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Can high-dose tranexamic acid have a role during transurethral resection of the prostate in large prostates? A randomised controlled trial. [2022]