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

Urologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05082142
• Other study ID #: STU00215134
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 17, 2021
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: March 2024
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Calculi
• Hypertrophy
• Kidney Calculi
• Nephrolithiasis
• Prostatic Hyperplasia
• Urologic Diseases

Intervention

Drug:
• Tranexamic acid
Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Same-day Discharge Rate	Number of participants who are discharged on the same day and have same-day catheter removal.	Day 0-1
Primary	Length of Stay	Post-operative to discharge home	Day 0-1
Primary	Same Day Discharge		24 hours
Secondary	Number of Participants With Bleeding Complications	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.	12 weeks
Secondary	Duration of Postoperative Hematuria	Days participants have postoperative hematuria. This will be assessed by a weekly survey distributed to participants for 12 weeks.	12 weeks
Secondary	Operative Times	Operative times during HoLEP procedure.	Day 0
Secondary	Adverse Events Related to TXA	Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures).	12 weeks