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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tranexamic acid (TXA) can reduce blood loss during Aquablation therapy for men with Benign Prostatic Hyperplasia (BPH), a condition that enlarges the prostate and causes urination problems. The goal is to determine if TXA can make surgery safer by minimizing blood loss, potentially leading to quicker recovery. Eligible participants are men diagnosed with BPH, scheduled for this specific surgical procedure, and experiencing notable symptoms. Participants will receive either TXA or a placebo before surgery, without knowing which one, to ensure unbiased results. All treatments are part of the normal surgical process, requiring no extra time or cost. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for tranexamic acid?

Research has shown that tranexamic acid (TXA) is generally safe for people. Studies have found that TXA effectively reduces blood loss during prostate surgeries without increasing the risk of serious issues like blood clots in veins or lungs. This is encouraging because it helps patients recover more quickly and safely.

In past studies, patients who received TXA experienced significantly less bleeding compared to those who did not take the drug. This suggests that TXA can be a safe choice for reducing blood loss during surgery. While side effects may occur, they are usually mild and manageable.

Overall, the evidence supports TXA as a safe treatment for reducing blood loss during surgery, especially for prostate procedures. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for enlarged prostate, which often involve medications like alpha-blockers or 5-alpha-reductase inhibitors, tranexamic acid (TXA) offers a unique approach by focusing on reducing blood loss during surgical procedures. TXA acts as an antifibrinolytic agent, stabilizing blood clots and minimizing bleeding, which is particularly beneficial during operations like Aquablation therapy. Researchers are excited about TXA because it could enhance surgical outcomes by reducing complications associated with blood loss, offering a potentially safer and more efficient option for patients undergoing prostate surgery.

What evidence suggests that tranexamic acid might be an effective treatment for reducing blood loss during Aquablation therapy for BPH?

In this trial, participants will receive either tranexamic acid (TXA) or a placebo to evaluate its effectiveness in reducing perioperative blood loss during prostate surgeries for an enlarged prostate. Studies have shown that TXA reduces blood loss during such surgeries by stabilizing blood clots, thereby minimizing bleeding. Specifically, previous studies found that patients who received TXA during prostate surgery lost less blood and required fewer blood transfusions. Importantly, TXA did not significantly increase the risk of complications such as deep vein thrombosis (a type of blood clot) or pulmonary embolism (a blockage in the lungs). These findings suggest that TXA may aid in quicker and safer recovery by reducing surgical bleeding. ^{1 2 3 4 6}

Who Is on the Research Team?

Christopher Tenggardjaja

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10039104/

Evaluating the effectiveness of tranexamic acid ... According to the findings of the current study, the administration of TXA led to reduce bleeding in BPH patients who underwent open prostatectomy. Furthermore, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06710327

Effect of Tranexamic Acid on Intraoperative Blood Loss in ... 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 ...

3. withpower.com withpower.com/trial/phase-4-hyperplasia-2025-4ac0e

Tranexamic Acid for Enlarged Prostate (TXA-AQ Trial) 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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818018302150

Systematic review and meta-analyses of tranexamic acid ... TXA reduced intraoperative blood loss and the need for transfusion, without increasing the risk of DVT and PE in prostate surgeries.

5. researchgate.net researchgate.net/publication/368712191_Evaluating_the_effectiveness_of_tranexamic_acid_administration_in_reducing_bleeding_in_benign_prostate_hyperplasia_patients_underwent_open_prostatectomy_A_double-blind_randomized_clinical_trial

(PDF) Evaluating the effectiveness of tranexamic acid ... Conclusion: According to the findings of the current study, the administration of TXA led to reduce bleeding in BPH patients who underwent open ...

6. spandidos-publications.com spandidos-publications.com/10.3892/etm.2018.7025

Tranexamic acid is beneficial for reducing perioperative ... In the current study, it was observed that in the TXA group, intraoperative blood loss was significantly lower compared with the control group.