CompletedPhase 4

Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)

United States110 participantsStarted 2021-09-17

Plain-language summary

This study is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP). The investigators attempt to perform HoLEP as a same-day discharge (SDD) procedure, but at Northwestern Memorial, the SDD rate is currently approximately 60%. The limiting factor in SDD is hematuria. Tranexamic acid (TXA) is a clot promoting drug that is commonly used by orthopedic, cardiac and obstetric surgeons to prevent bleeding. The primary outcome will be to assess if there is a difference in SDD rates in those who receive TXA vs. those who do not. Secondary outcomes will assess bleeding complications (defined as unplanned ED visit/clinic visit/procedure/admission related to bleeding, clot retention, clot evacuation, need for perioperative transfusion) between participants who receive TXA vs. those do not. The study will also assess differences in perioperative complications associated with TXA including but not limited to: deep venous thrombosis, pulmonary embolism, cerebrovascular events, between the groups. The study will also assess for the duration of postoperative hematuria between groups as well as differences in operative times between the groups. The investigators anticipate that there may be up to a 25% increase in SDD rates in those who receive TXA vs. those who do not.

Who can participate

Age range

18 Years – 89 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males 18-89 undergoing HoLEP * Willing to sign the Informed Consent Form * Able to read, understand, and complete patient questionnaires, pain texts, and medication diary Exclusion Criteria: * Allergy or hypersensitivity to TXA, history of acute venous or arterial thrombosis, intrinsic risk for thrombosis or thromboembolism, history of thromboembolic disease, hereditary thrombophilia, use of hormonal agents * Patients having any additional simultaneous procedure other than a HoLEP (cystolitholapaxy allowed). * Anticipated need for perineal urethrostomy at the time of HoLEP * Patient not undergoing catheter removal and voiding trial at Northwestern Memorial Hospital

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Same-day Discharge Rate

Timeframe: Day 0-1

Length of Stay

Timeframe: Day 0-1

Same Day Discharge

Timeframe: 24 hours

Trial details

NCT IDNCT05082142

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-15

Results submitted2023-02-13

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