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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 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 110 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05082142
The ClinicalTrials.gov registry entry for NCT05082142 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tranexamic acid is the first listed.
NCT05082142 reports 0 study locations.
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.
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