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COMPLETED
NCT05082142
PHASE4

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

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2021-09-17

Completion Date

2022-12-14

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

Tranexamic acid

Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.

Locations (1)

Northwestern University

Chicago, Illinois, United States