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Completed

NCT Number: NCT05082142

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

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.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

Primary outcomes

  1. Same-day Discharge Rate

    Time frame: Day 0-1

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

  2. Length of Stay

    Time frame: Day 0-1

    Post-operative to discharge home

  3. Same Day Discharge

    Time frame: 24 hours

Secondary outcomes

  1. Number of Participants With Bleeding Complications

    Time frame: 12 weeks

    Participants who have bleeding complications (defined as unplanned ED visit/clinic/procedure/admission related to bleeding, clot retention, clot evacuation, need for perioperative transfusion). This will be assessed by a weekly survey distributed to participants for 12 weeks.

  2. Duration of Postoperative Hematuria

    Time frame: 12 weeks

    Days participants have postoperative hematuria. This will be assessed by a weekly survey distributed to participants for 12 weeks.

  3. Operative Times

    Time frame: Day 0

    Operative times during HoLEP procedure.

  4. Adverse Events Related to TXA

    Time frame: 12 weeks

    Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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