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Phase 4 Completed N=110 Randomized Treatment

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

Kidney Calculi · Urologic Diseases · Benign Prostatic Hypertrophy
Source: ClinicalTrials.gov NCT05082142 ↗
Enrolled (actual)
110
Serious AEs
0.9%
Results posted
Apr 2023
Primary outcomePrimary: Same-day Discharge Rate — 50; 49 Participants
◆ Published Evidence
Emerging
11citations · ~4 / year
Tranexamic Acid Does Not Improve Outcomes of Holmium Laser Enucleation of the Prostate: A Prospective Randomized Controlled Trial.
Journal of endourology · 2023 · Likely link

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.

Linked Publications

  • Tranexamic Acid Does Not Improve Outcomes of Holmium Laser Enucleation of the Prostate: A Prospective Randomized Controlled Trial.
    Journal of endourology · 2023 · 11 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Same-day Discharge Rate
50; 49
PRIMARY
Length of Stay
170; 187
PRIMARY
Same Day Discharge
51; 49
SECONDARY
Number of Participants With Bleeding Complications
4; 6
SECONDARY
Duration of Postoperative Hematuria
SECONDARY
Operative Times
58; 53
SECONDARY
Adverse Events Related to TXA
0; 0

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05082142) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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