Kidney CalculiPhase 4NCT05082142
Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
A Phase 4 study testing Tranexamic acid in people with Kidney Calculi and Urologic Diseases, run by Northwestern University at 1 site in United States.
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%. Read more about this study
- Who is it for?
- Ages 18 to 89 years, men only
- Conditions the study is for
- Kidney Calculi, Urologic Diseases, Benign Prostatic Hypertrophy
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2021to 14 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Tranexamic acid
- Medical subject headings
- Kidney Calculi, Urologic Diseases, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.
| Study group | Role | What they receive |
|---|---|---|
| TXA intraoperatively | Experimental | Patients will receive intraoperative 1g TXA during the HoLEP procedure. Receives: Drug: Tranexamic acid |
| No TXA intraoperatively | No intervention | Patients will not receive intraoperative TXA during the HoLEP procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Same-day Discharge Rate
Number of participants who are discharged on the same day and have same-day catheter removal.
Measured: Day 0-1
Length of Stay
Post-operative to discharge home
Measured: Day 0-1
Same Day Catheter Removal
Number of participants who have same-day catheter removal.
Measured: 24 hours
Secondary outcomes (4)
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.
Measured: 12 weeks
Number of Participants With Postoperative Hematuria
Number of participants who have postoperative hematuria. This will be assessed by a weekly survey distributed to participants for 12 weeks.
Measured: 12 weeks
Operative Times
Operative times during HoLEP procedure.
Measured: Day 0
Adverse Events Related to TXA
Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start17 Sep 2021
- Primary completion15 Jun 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082142
- Sponsor's protocol ID
- STU00215134
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2021
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36222618
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
- ClinicalTrials.gov ID
- NCT05082142
- Acronym / sponsor ID
- STU00215134
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA intraoperatively | Experimental | Drug: Tranexamic acidPatients will receive intraoperative 1g TXA during the HoLEP procedure. |
| No TXA intraoperatively | No intervention | –Patients will not receive intraoperative TXA during the HoLEP procedure. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidPatients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure. | Drug | TXA intraoperatively |
Primary outcome
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.
Length of Stay
Time frame: Day 0-1
Post-operative to discharge home
Same Day Catheter Removal
Time frame: 24 hours
Number of participants who have same-day catheter removal.
4 secondary outcomes
Number of Participants With Bleeding Complications
Time frame: 12 weeks
Number of Participants With Postoperative Hematuria
Time frame: 12 weeks
Operative Times
Time frame: Day 0
Adverse Events Related to TXA
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36222618Assmus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid in people with Kidney Calculi and Urologic Diseases, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Same-day Discharge Rate (time frame: Day 0-1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05082142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.