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NCT06710327 · ClinicalTrials.gov registry record · Phase 4
Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Aquablation
A Phase 4 study, sponsored by Kaiser Permanente.
- Not yet
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT06710327: Clinical Trial Phase 4 study, sponsored by Kaiser Permanente.
NCT06710327 is a Phase 4 study that has not yet begun recruiting, run by Kaiser Permanente. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06710327, a Phase 4 study, has not yet begun recruiting, sponsored by Kaiser Permanente.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study 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.
Primary Outcome
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 hem
Interventions
- DRUG Placebo
- DRUG Tranexamic Acid (IV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2025-01 |
| Est. Completion | 2025-08 |
| Phase | Phase 4 |
What is known before NCT06710327 opens enrollment
NCT06710327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06710327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06710327 about?
NCT06710327 is a clinical study titled "Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Aquablation". 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 o...
What is the current status of trial NCT06710327?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2025-01. Estimated completion is 2025-08.
What interventions are being tested in trial NCT06710327?
The interventions under investigation include: Placebo (DRUG), Tranexamic Acid (IV) (DRUG).
Who is sponsoring clinical trial NCT06710327?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06710327's enrollment target sits among peer trials
56 1213th of 2000 higher than 783 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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