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NCT05082142 · ClinicalTrials.gov registry record · Phase 4
Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
NCT05082142: Completed Phase 4 study, sponsored by Northwestern University.
NCT05082142 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05082142, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants who are discharged on the same day and have same-day catheter removal.
Interventions
- DRUG Tranexamic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2021-09-17 |
| Est. Completion | 2022-12-14 |
| Phase | Phase 4 |
What the finished NCT05082142 record still lists
NCT05082142 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Tranexamic acid is the first listed.
NCT05082142 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05082142 about?
NCT05082142 is a clinical study titled "Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)". 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 appro...
What is the current status of trial NCT05082142?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2021-09-17. Estimated completion is 2022-12-14.
What interventions are being tested in trial NCT05082142?
The interventions under investigation include: Tranexamic acid (DRUG).
Who is sponsoring clinical trial NCT05082142?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05082142's enrollment target sits among peer trials
110 727th of 2000 higher than 1,264 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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