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

NCT05082142 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-05-16

Study results available
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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.

Conditions

  • Kidney Calculi
  • Urologic Diseases
  • Benign Prostatic Hypertrophy

Interventions

DRUG

Tranexamic acid

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2022-06-15
Completion
2022-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05082142 on ClinicalTrials.gov