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Tranexamic Acid for Enlarged Prostate (TXA-AQ Trial)

Phase 4

Waitlist Available

Led By Christopher F Tenggardjaja, MD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Exhibiting clinically significant symptoms of BPH.

Male participants diagnosed with BPH scheduled for Aquablation therapy

Must not have

Renal insufficiency

Diagnosis of prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from initiation of surgery to post-operative follow up, up to 60 days post-surgery.

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to see if a medication called tranexamic acid (TXA) can reduce blood loss during Aquablation therapy, a surgery for men with Benign Prostatic Hyperplasia (

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Tranexamic Acid may cause side effects such as nausea, diarrhea, vomiting, headaches, muscle cramps, or an increased risk of blood clots. However, the exact side effects in this surgical context will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have noticeable symptoms from an enlarged prostate.

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I am a man scheduled for Aquablation therapy for BPH.

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I am 45 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidneys do not work properly.

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I have been diagnosed with prostate cancer.

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I have a history of blood clots or am at high risk for them.

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I have heart or brain blood vessel diseases before surgery.

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I am currently on blood thinners.

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I have a blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from initiation of surgery to post-operative follow up, up to 60 days post-surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from initiation of surgery to post-operative follow up, up to 60 days post-surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of surgery to post-operative follow up, up to 60 days post-surgery. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Perioperative Hemoglobin Change

Secondary study objectives

Change in ProThrombin Time (PT) Following Tranexamic Acid Administration

Change in activated fibrinogen level Following Tranexamic Acid Administration

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

+2 more

Side effects data

From 2017 Phase 4 trial • 246 Patients • NCT02030821

Deep Infection

Superficial Cellulitis

Hematoma/Seroma

100%

80%

60%

40%

20%

Study treatment Arm

Tranexamic Acid (TXA) - Total Hip Arthroplasty

Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty

Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty

Tranexamic Acid (TXA) - Total Knee Arthroplasty

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TXA AdministrationExperimental Treatment1 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: PlaceboPlacebo Group1 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.

0 / 9Eligibility criteria met