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

  • STATUS
    Recruiting
  • days left to enroll
    45
  • participants needed
    110
  • sponsor
    Northwestern University
Updated on 26 October 2021

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.

Description

On the day of the surgery, the treatment assigned to the participant will be determined by chance, like flipping a coin. One arm will undergo the HoLEP procedure while receiving 1g TXA IV intraoperatively. The second arm will undergo the HoLEP procedure without receiving TXA IV intraoperatively.

After surgery, participants will receive weekly surveys via text message or email asking them to report any instances of difficulty urinating or blood in the urine. These surveys will continue for 12 weeks.

30 days after surgery, participants will come in for a standard clinical follow up appointment where they will be asked to complete a questionnaire about bleeding complications and symptoms.

12 weeks after surgery, participants will come in for their 12-week follow up and will be assessed for benign prostate hyperplasia (BPH) symptoms and their urine flow rate will be measured.

Details
Condition Nephrolithiasis, uropathy, urological disease, urinary tract disorders, Benign Prostatic Hyperplasia (Enlarged Prostate), renal stones, benign prostatic hyperplasia (bph), Kidney Stones, Prostatic disorder, urological diseases, KIDNEY STONE, Benign prostatic hypertrophy, URINARY TRACT DISORDER, Prostate Disorders, urinary tract disease
Treatment Tranexamic Acid
Clinical Study IdentifierNCT05082142
SponsorNorthwestern University
Last Modified on26 October 2021

Eligibility

Yes No Not Sure

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
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