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

Primary Purpose

Kidney Calculi, Urologic Diseases, Benign Prostatic Hypertrophy

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TXA intraoperatively

No TXA intraoperatively

Arm Description

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

Patients will not receive intraoperative TXA during the HoLEP procedure.

Outcomes

Primary Outcome Measures

Same-day Discharge Rate
Number of participants who are discharged on the same day and have same-day catheter removal.
Length of Stay
Post-operative to discharge home
Same Day Discharge

Secondary Outcome Measures

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.
Duration of Postoperative Hematuria
Days participants have postoperative hematuria. This will be assessed by a weekly survey distributed to participants for 12 weeks.
Operative Times
Operative times during HoLEP procedure.
Adverse Events Related to TXA
Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures).

Full Information

First Posted
September 24, 2021
Last Updated
September 19, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05082142
Brief Title
Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
Official Title
Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi, Urologic Diseases, Benign Prostatic Hypertrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TXA intraoperatively
Arm Type
Experimental
Arm Description
Patients will receive intraoperative 1g TXA during the HoLEP procedure.
Arm Title
No TXA intraoperatively
Arm Type
No Intervention
Arm Description
Patients will not receive intraoperative TXA during the HoLEP procedure.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.
Primary Outcome Measure Information:
Title
Same-day Discharge Rate
Description
Number of participants who are discharged on the same day and have same-day catheter removal.
Time Frame
Day 0-1
Title
Length of Stay
Description
Post-operative to discharge home
Time Frame
Day 0-1
Title
Same Day Discharge
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of Participants With Bleeding Complications
Description
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.
Time Frame
12 weeks
Title
Duration of Postoperative Hematuria
Description
Days participants have postoperative hematuria. This will be assessed by a weekly survey distributed to participants for 12 weeks.
Time Frame
12 weeks
Title
Operative Times
Description
Operative times during HoLEP procedure.
Time Frame
Day 0
Title
Adverse Events Related to TXA
Description
Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures).
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36222618
Citation
Assmus MA, Lee MS, Helon JW, Krambeck AE. Tranexamic Acid Does Not Improve Outcomes of Holmium Laser Enucleation of the Prostate: A Prospective Randomized Controlled Trial. J Endourol. 2023 Feb;37(2):171-178. doi: 10.1089/end.2022.0407. Epub 2022 Dec 27.
Results Reference
derived

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

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