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

NCT05082142 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STU00215134
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Same-day Discharge Rate

  Number of participants who are discharged on the same day and have same-day catheter removal.

  Day 0-1

• Length of Stay

  Post-operative to discharge home

  Day 0-1

• Same Day Discharge

  24 hours

Secondary Outcomes (4)

• Number of Participants With Bleeding Complications

  12 weeks

• Duration of Postoperative Hematuria

  12 weeks

• Operative Times

  Day 0

• Adverse Events Related to TXA

  12 weeks

Study Arms (2)

TXA intraoperatively

EXPERIMENTAL

Patients will receive intraoperative 1g TXA during the HoLEP procedure.

Drug: Tranexamic acid

No TXA intraoperatively

NO INTERVENTION

Patients will not receive intraoperative TXA during the HoLEP procedure.

Interventions

Tranexamic acid DRUG

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

TXA intraoperatively

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males 18-89 undergoing HoLEP
• Willing to sign the Informed Consent Form
• Able to read, understand, and complete patient questionnaires, pain texts, and medication diary

You may not qualify if:

• Allergy or hypersensitivity to TXA, history of acute venous or arterial thrombosis, intrinsic risk for thrombosis or thromboembolism, history of thromboembolic disease, hereditary thrombophilia, use of hormonal agents
• Patients having any additional simultaneous procedure other than a HoLEP (cystolitholapaxy allowed).
• Anticipated need for perineal urethrostomy at the time of HoLEP
• Patient not undergoing catheter removal and voiding trial at Northwestern Memorial Hospital

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Assmus MA, Lee MS, Helon JW, Krambeck AE. Tranexamic Acid Does Not Improve Outcomes of Holmium Laser Enucleation of the Prostate: A Prospective Randomized Controlled Trial. J Endourol. 2023 Feb;37(2):171-178. doi: 10.1089/end.2022.0407. Epub 2022 Dec 27.

  PMID: 36222618 DERIVED

MeSH Terms

Conditions

Kidney Calculi; Urologic Diseases; Prostatic Hyperplasia

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Nicholas Dean (current fellow)
• Organization: Northwestern University

nicholas.dean@northwestern.edu

7806906285

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 18, 2021
• Study Start: September 17, 2021
• Primary Completion: June 15, 2022
• Study Completion: December 14, 2022
• Last Updated: May 16, 2024
• Results First Posted: April 7, 2023

Record last verified: 2024-04

Locations

US (1)