Urethral StricturePhase 4REDUCERNCT07501884
REDUCER Trial (TXA in Urethroplasty)
A Phase 4 study testing Tranexamic Acid and Urethroplasty in people with Urethral Stricture and Urethral Diseases, run by Amjad Alwaal, MD, MSc, FRCSC, FACS at 1 site in United States.
Trial summary
This study will test whether tranexamic acid (TXA), a medication used to reduce bleeding, can decrease blood loss in patients having urethroplasty. Participants will be randomly assigned to receive either a single intravenous dose of TXA at the start of anesthesia or standard care without TXA. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Stricture, Urethral Diseases
- What is being tested?
- Tranexamic Acid and Urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years old)
- Undergoing urethroplasty for urethral stricture disease
- Ability to provide informed consent
Who cannot join
- Known contraindication to tranexamic acid (TXA)
- History of thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, stroke)
- Known bleeding disorder or coagulopathy
- Current use of anticoagulation that cannot be safely held perioperatively
- Severe renal impairment
- Allergy or hypersensitivity to tranexamic acid
- History of seizures
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospital
Newark, New Jersey, 07103
Amjad Alwaal, MD, 973-972-4418, amjad.alwaal@rutgers.edu
About this study
Official title: Reduction of Perioperative Blood Loss in Urethral Reconstruction Using Tranexamic Acid (REDUCER Trial): A Multicenter Pragmatic Randomized Study
This study will test whether tranexamic acid (TXA), a medication used to reduce bleeding, can decrease blood loss in patients having urethroplasty. Participants will be randomly assigned to receive either a single intravenous dose of TXA at the start of anesthesia or standard care without TXA. Researchers will compare hemoglobin change after surgery as well as estimated blood loss and complications.
Read the detailed description
Urethroplasty can be associated with variable perioperative blood loss. Tranexamic acid (TXA) is an antifibrinolytic medication that has been shown to reduce blood loss in multiple surgical settings, but it has not been well studied in urethroplasty.
This is a prospective, randomized, open-label trial evaluating the effect of a single perioperative dose of TXA in adult patients undergoing elective urethroplasty. Participants will be assigned in a 1:1 ratio to receive either TXA or standard care without TXA. TXA will be administered as a single intravenous dose at induction of anesthesia.
The primary outcome is postoperative change in hemoglobin. Secondary outcomes include estimated blood loss, operative time, transfusion requirement, and perioperative complications. Participants will be followed through the postoperative period, including routine clinical follow-up.
Study data will be collected from routine clinical care and the electronic medical record. The goal of this study is to determine whether TXA may provide a simple and practical strategy to reduce blood loss in urethroplasty.
- Conditions
- Urethral Stricture, Urethral Diseases
- Being tested
- Tranexamic Acid, Urethroplasty
- Keywords
- Tranexamic Acid, Urethroplasty, Blood Loss, Hemoglobin, Reconstructive Urology
- Medical subject headings
- Urethral Stricture, Urethral Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Tranexamic acid (TXA) will be administered perioperatively according to institutional protocol to reduce intraoperative and postoperative bleeding.
UrethroplastyProcedure or surgery
Surgical urethral reconstruction performed according to standard institutional techniques.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid (TXA) | Experimental | Participants undergoing urethroplasty will receive tranexamic acid (TXA) administered perioperatively in addition to standard surgical care. Receives: Drug: Tranexamic Acid |
| Standard of Care (No TXA) | Active comparator | Participants undergoing urethroplasty will receive standard surgical care without tranexamic acid. Receives: Procedure: Urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin
Difference between preoperative hemoglobin and postoperative hemoglobin measured as part of routine clinical care.
Measured: Baseline to postoperative day 5-7
Secondary outcomes (4)
Estimated intraoperative blood loss (milliliters)
Estimated intraoperative blood loss in milliliters (mL) as recorded in the anesthesia record and operative report during surgery.
Measured: During surgery
Total operative time (minutes)
Operative time in minutes, defined as time from surgical incision to skin closure completion, as documented in the operative report.
Measured: During surgery
Intraoperative surgical field quality assessed by the Boezaart Surgical Field Grading Scale
Intraoperative surgical field quality will be assessed by the operating surgeon using the Boezaart Surgical Field Grading Scale, a 6-point ordinal scale ranging from 0 to 5, where 0 = no bleeding, 1 = slight bleeding with no suction required, 2 = slight bleeding requiring occasional suction, 3 = slight bleeding requiring frequent suction and threatening the surgical field, 4 = moderate bleeding requiring frequent suction and significantly threatening the surgical field, and 5 = severe bleeding requiring constant suction and making surgery nearly impossible. Higher scores indicate worse operative field quality.
Measured: During surgery
30-day postoperative complications
Postoperative complications, including bleeding-related events.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomized in a 1:1 ratio to receive either tranexamic acid (TXA) or standard of care without TXA. Allocation will occur prior to surgery. Each participant will remain in their assigned group throughout the study, and outcomes will be compared between the two parallel groups.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amjad Alwaal, MD, MSc, FRCSC, FACS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amjad Alwaal, MD, MSc, FRCSC, FACS, Rutgers, The State University of New Jersey
- Investigators
- Amjad Alwaal, MD, MSc, FACS, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501884
- Sponsor's protocol ID
- Pro2026000612
- Other IDs
- Pro2026000612
- Acronym
- REDUCER
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and the absence of a formal data sharing plan at this time.
Publications
Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
PubMed 22611164CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
PubMed 20554319
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Perioperative Blood Loss in Urethral Reconstruction Using Tranexamic Acid (REDUCER Trial): A Multicenter Pragmatic Randomized Study
- ClinicalTrials.gov ID
- NCT07501884
- Acronym / sponsor ID
- REDUCER / Pro2026000612
- Conditions
- Urethral Stricture, Urethral Diseases
- Keywords
- Tranexamic Acid, Urethroplasty, Blood Loss, Hemoglobin, Reconstructive Urology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Amjad Alwaal, MD, MSc, FRCSC, FACSUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether tranexamic acid (TXA), a medication used to reduce bleeding, can decrease blood loss in patients having urethroplasty. Participants will be randomly assigned to receive either a single intravenous dose of TXA at the start of anesthesia or standard care without TXA. Researchers will compare hemoglobin change after surgery as well as estimated blood loss and complications.
Detailed description
Urethroplasty can be associated with variable perioperative blood loss. Tranexamic acid (TXA) is an antifibrinolytic medication that has been shown to reduce blood loss in multiple surgical settings, but it has not been well studied in urethroplasty.
This is a prospective, randomized, open-label trial evaluating the effect of a single perioperative dose of TXA in adult patients undergoing elective urethroplasty. Participants will be assigned in a 1:1 ratio to receive either TXA or standard care without TXA. TXA will be administered as a single intravenous dose at induction of anesthesia.
The primary outcome is postoperative change in hemoglobin. Secondary outcomes include estimated blood loss, operative time, transfusion requirement, and perioperative complications. Participants will be followed through the postoperative period, including routine clinical follow-up.
Study data will be collected from routine clinical care and the electronic medical record. The goal of this study is to determine whether TXA may provide a simple and practical strategy to reduce blood loss in urethroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either tranexamic acid (TXA) or standard of care without TXA. Allocation will occur prior to surgery. Each participant will remain in their assigned group throughout the study, and outcomes will be compared between the two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid (TXA) | Experimental | Drug: Tranexamic AcidParticipants undergoing urethroplasty will receive tranexamic acid (TXA) administered perioperatively in addition to standard surgical care. |
| Standard of Care (No TXA) | Active comparator | Procedure: UrethroplastyParticipants undergoing urethroplasty will receive standard surgical care without tranexamic acid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥18 years old)
- Undergoing urethroplasty for urethral stricture disease
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- Known contraindication to tranexamic acid (TXA)
- History of thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, stroke)
- Known bleeding disorder or coagulopathy
- Current use of anticoagulation that cannot be safely held perioperatively
- Severe renal impairment
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 AcidTranexamic acid (TXA) will be administered perioperatively according to institutional protocol to reduce intraoperative and postoperative bleeding. | Drug | Tranexamic Acid (TXA) |
| UrethroplastySurgical urethral reconstruction performed according to standard institutional techniques. | Procedure or surgery | Standard of Care (No TXA) |
Primary outcome
Change in hemoglobin
Time frame: Baseline to postoperative day 5-7
Difference between preoperative hemoglobin and postoperative hemoglobin measured as part of routine clinical care.
4 secondary outcomes
Estimated intraoperative blood loss (milliliters)
Time frame: During surgery
Total operative time (minutes)
Time frame: During surgery
Intraoperative surgical field quality assessed by the Boezaart Surgical Field Grading Scale
Time frame: During surgery
30-day postoperative complications
Time frame: Within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Results publication: PubMed 22611164Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
- Results publication: PubMed 20554319CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and the absence of a formal data sharing plan at this time.
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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.
Amjad Alwaal, MD, MSc, FACS principal investigator
Rutgers University
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 and Urethroplasty in people with Urethral Stricture and Urethral Diseases, run by Amjad Alwaal, MD, MSc, FRCSC, FACS 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 8 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: opening soon, as of the sponsor's last update on 13 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amjad Alwaal, MD, MSc, FACS (973-972-4418, amjad.alwaal@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin (time frame: Baseline to postoperative day 5-7). 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 NCT07501884, which also lists 2 linked publications.
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 13 Aug 2026.