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Antifibrinolytic Agent

Tranexamic Acid for Prostate Enlargement

Phase 4
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study Summary

This trial will assess if a drug called TXA can improve same day discharge rates after a prostate surgery. Primary outcome is SDD rate and secondary outcomes include bleeding, clot retention, and other complications.

Who is the study for?
This trial is for males aged 18-89 who are undergoing a prostate surgery called HoLEP and can complete questionnaires. It's not for those with a history of blood clots, thrombosis risks, additional simultaneous procedures (except cystolitholapaxy), or allergies to Tranexamic acid.Check my eligibility
What is being tested?
The study tests if Tranexamic acid (TXA), a drug that helps blood clot, can increase the rate of patients going home the same day after HoLEP surgery. The comparison is between patients receiving TXA and those who do not.See study design
What are the potential side effects?
Possible side effects of TXA may include an increased risk of blood clots like deep vein thrombosis or pulmonary embolism, stroke events, and prolonged bleeding after surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Length of Stay
Same Day Discharge
Same-day Discharge Rate
Secondary outcome measures
Adverse Events Related to TXA
Duration of Postoperative Hematuria
Number of Participants With Bleeding Complications
+1 more

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116
22%
Readmissions
14%
Postoperative infections
10%
Re-operations
4%
Thromboembolic events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Tranexamic Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TXA intraoperativelyExperimental Treatment1 Intervention
Patients will receive intraoperative 1g TXA during the HoLEP procedure.
Group II: No TXA intraoperativelyActive Control1 Intervention
Patients will not receive intraoperative TXA during the HoLEP procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,121 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
Amy Krambeck 2021. "Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05082142.
~31 spots leftby Apr 2025
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