Urologic Diseases Clinical Trial
Official title:
Tranexamic Acid to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
Verified date | April 2024 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 14, 2022 |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06397287 -
PROM Project Urology
|
||
Completed |
NCT03572348 -
VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.
|
N/A | |
Completed |
NCT03339609 -
Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children
|
N/A | |
Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
N/A | |
Completed |
NCT03668262 -
ED50 of Cis-atracurium for Laryngeal Mask Incubation in General Anesthesia
|
||
Recruiting |
NCT04763538 -
Quality and Outcome Measurements of Urological Patients
|
||
Not yet recruiting |
NCT03899298 -
Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
|
Phase 1 | |
Completed |
NCT05032287 -
Medical Expulsive Therapy Post-SWL For Renal Stones
|
N/A | |
Active, not recruiting |
NCT03243682 -
The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones
|
N/A | |
Recruiting |
NCT05169892 -
Aquablation in Benign Prostatic Hyperplasia in Canada
|
||
Enrolling by invitation |
NCT03234543 -
Remote Ischemic Conditioning in Abdominal Surgery
|
N/A | |
Recruiting |
NCT05201131 -
Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
|
||
Recruiting |
NCT06187870 -
Bank of Biological Material From Patients and Healthy Donors for the Study of Urological and Uro-oncological Pathologies
|
||
Completed |
NCT03847909 -
A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2
|
Phase 2 | |
Recruiting |
NCT04972890 -
The Outcomes of Intracavernosal Umbilical Cord Mesenchymal Stem Cells Implantation in Patients With Diabetic Erectile Dysfunction
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT03258658 -
Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures
|
Phase 1 | |
Terminated |
NCT02543645 -
A Study of Varlilumab and Atezolizumab in Patients With Advanced Cancer
|
Phase 1 | |
Terminated |
NCT03843073 -
Connected Catheter- Safety and Effectiveness Study
|
N/A | |
Terminated |
NCT04826484 -
Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
|
Phase 3 | |
Terminated |
NCT04059159 -
Connected Catheter - Safety and Effectiveness Study
|
N/A |