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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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