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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXA intraoperatively | Experimental | Patients will receive intraoperative 1g TXA during the HoLEP procedure. |
|
| No TXA intraoperatively | No Intervention | Patients will not receive intraoperative TXA during the HoLEP procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Same-day Discharge Rate | Number of participants who are discharged on the same day and have same-day catheter removal. | Day 0-1 |
| Length of Stay | Post-operative to discharge home | Day 0-1 |
| Same Day Discharge | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36222618 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TXA Intraoperatively | Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure. |
| FG001 | No TXA Intraoperatively | Patients will not receive intraoperative TXA during the HoLEP procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TXA Intraoperatively | Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure. |
| BG001 | No TXA Intraoperatively |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Same-day Discharge Rate | Number of participants who are discharged on the same day and have same-day catheter removal. | Posted | Count of Participants | Participants | Day 0-1 |
|
90-day complications post-operatively
Clavien Dindo classification was used to categorize complications
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TXA Intraoperatively | Patients will receive intraoperative 1g TXA during the HoLEP procedure. Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CD IIIb | Renal and urinary disorders | Systematic Assessment | ureteroscopy for obstructing ureteral stone |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CD I | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Dean (current fellow) | Northwestern University | 7806906285 | nicholas.dean@northwestern.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 29, 2021 | Mar 8, 2023 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 29, 2021 | Feb 8, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D014570 | Urologic Diseases |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 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 |
| Operative Times | Operative times during HoLEP procedure. | Day 0 |
| Adverse Events Related to TXA | Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures). | 12 weeks |
Patients will not receive intraoperative TXA during the HoLEP procedure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-op Prostate size, continious | Median | Full Range | cc |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Length of Stay | Post-operative to discharge home | Posted | Median | Inter-Quartile Range | minutes | Day 0-1 |
|
|
|
| Primary | Same Day Discharge | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Not Posted | 12 weeks | Participants |
| Secondary | Operative Times | Operative times during HoLEP procedure. | Posted | Median | Inter-Quartile Range | minutes | Day 0 |
|
|
|
| Secondary | Adverse Events Related to TXA | Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures). | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 0 |
| 55 |
| 1 |
| 55 |
| 9 |
| 55 |
| EG001 | No TXA Intraoperatively | Patients will not receive intraoperative TXA during the HoLEP procedure. | 0 | 55 | 0 | 55 | 17 | 55 |
|
| CD II | Renal and urinary disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |