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

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05082142

Collaborator

(none)

110

Enrollment

Location

Arms

11.5

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Calculi Urologic Diseases Benign Prostatic Hypertrophy	Drug: Tranexamic acid	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 17, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TXA intraoperatively Patients will receive intraoperative 1g TXA during the HoLEP procedure.	Drug: Tranexamic acid Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.
No Intervention: No TXA intraoperatively Patients will not receive intraoperative TXA during the HoLEP procedure.

Arm

Intervention/Treatment

Experimental: TXA intraoperatively

Patients will receive intraoperative 1g TXA during the HoLEP procedure.

Drug: Tranexamic acid

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

No Intervention: No TXA intraoperatively

Patients will not receive intraoperative TXA during the HoLEP procedure.

Outcome Measures

Primary Outcome Measures

Same-day discharge rate [Day 0-1]
Number of participants who are discharged on the same day and have same-day catheter removal.

Secondary Outcome Measures

Number of participants with bleeding complications [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.
Duration of postoperative hematuria [12 weeks]
Days participants have postoperative hematuria. This will be assessed by a weekly survey distributed to participants for 12 weeks.
Operative, enucleation, and morcellation times [Day 0]
Operative, enucleation, and morcellation times during HoLEP procedure.
Adverse events related to TXA [12 weeks]
Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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