Benign Prostatic HyperplasiaPhase 4TXA-TURPNCT07460518
Tranexamic Acid for Bleeding Reduction During TURP Surgery
A Phase 4 study testing Tranexamic Acid in people with Benign Prostatic Hyperplasia and Transurethral Resection of the Prostate, run by Hamza Najout at 1 site in Morocco.
Trial summary
Transurethral resection of the prostate (TURP) is commonly performed in elderly patients and may be associated with perioperative bleeding leading to postoperative anemia and delayed recovery. Tranexamic acid (TXA), an antifibrinolytic agent, may reduce surgical bleeding by inhibiting fibrin degradation. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate, Perioperative Bleeding
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMorocco
- Study dates
- 30 Mar 2026to 30 Oct 2026
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 50 years or older
- Diagnosed with benign prostatic hyperplasia (BPH)
- Scheduled for elective transurethral resection of the prostate (TURP) under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Provided written informed consent
Who cannot join
- History of thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke)
- Known hypersensitivity to tranexamic acid
- Severe renal impairment (creatinine clearance <30 mL/min)
- Coagulation disorders
- Current anticoagulant therapy not appropriately discontinued
- History of seizure disorder
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Morocco1 site, 1 recruiting
- Recruiting
Mohammed V Military Teaching Hospital
Rabat, 10180
Hamza Najout, MD, PhD, +212672188155, hamza.najout@gmail.com
hamza najout, MD, PhD(c)
About this study
Official title: Tranexamic Acid for Perioperative Haemostatic Optimisation During Transurethral Resection of the Prostate: A Randomized Quadruple-Blind Placebo-Controlled Trial
Transurethral resection of the prostate (TURP) is commonly performed in elderly patients and may be associated with perioperative bleeding leading to postoperative anemia and delayed recovery. Tranexamic acid (TXA), an antifibrinolytic agent, may reduce surgical bleeding by inhibiting fibrin degradation.
This prospective randomized quadruple-blind placebo-controlled clinical trial evaluates whether perioperative administration of intravenous tranexamic acid reduces intraoperative blood loss and preserves postoperative hemoglobin concentration in patients undergoing TURP under standardized spinal anesthesia.
Read more
Participants are randomly assigned to receive either intravenous tranexamic acid or placebo prior to surgery. The primary outcomes assess objective measures of perioperative blood loss and postoperative hemoglobin levels. Secondary outcomes include recovery parameters, perioperative safety, and exploratory hospital-level economic impact.
The study aims to determine whether anesthesia-led haemostatic optimization using tranexamic acid improves perioperative physiological stability and recovery efficiency within an enhanced recovery framework.
Read the detailed description
This investigator-initiated, prospective, randomized, quadruple-blind, placebo-controlled clinical trial is conducted at Mohammed V Military Teaching Hospital, Rabat, Morocco.
The study evaluates tranexamic acid as a perioperative blood management intervention during transurethral resection of the prostate performed under standardized spinal anesthesia within an enhanced recovery pathway. TURP surgery is characterized by local fibrinolytic activation that may contribute to continuous microvascular bleeding. Tranexamic acid inhibits plasminogen activation and may therefore reduce intraoperative haemoglobin loss.
Eligible participants undergoing elective TURP are randomized in a 1:1 ratio to receive either intravenous tranexamic acid (10 mg/kg) administered prior to surgical resection or placebo. Allocation concealment and quadruple blinding include participants, care providers, investigators, and outcome assessors.
The study includes two complementary co-primary haemostatic endpoints:
- total haemoglobin mass recovered in irrigation effluent as an objective measure of intraoperative blood loss, and
- postoperative haemoglobin concentration measured at 24 hours.
Secondary outcomes evaluate perioperative recovery variables, transfusion requirement, hospital length of stay, adverse events, and exploratory health-economic impact from a hospital perspective.
A prespecified interim analysis evaluates feasibility, treatment effect estimation, and safety signals without early stopping rules. Final confirmatory analysis will be performed after completion of planned enrollment.
- Conditions
- Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate, Perioperative Bleeding, Anemia, Postoperative
- Being tested
- Tranexamic Acid, Placebo (Normal Saline)
- Keywords
- Tranexamic Acid, TURP, Patient Blood Management, Spinal Anesthesia, Randomized Controlled Trial, Hemostasis, Enhanced Recovery After Surgery, Perioperative Medicine
- Medical subject headings
- Prostatic Hyperplasia, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Intravenous tranexamic acid administered at a dose of 10 mg/kg approximately 30 minutes before surgical resection to reduce perioperative bleeding during transurethral resection of the prostate.
Placebo (Normal Saline)Drug
Intravenous administration of normal saline placebo prepared to be identical in appearance and volume to the tranexamic acid solution to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid Group | Experimental | Participants receive intravenous tranexamic acid (10 mg/kg) administered approximately 30 minutes before transurethral resection of the prostate under standardized spinal anesthesia. Receives: Drug: Tranexamic Acid |
| Placebo Group | Placebo comparator | Participants receive an identical volume of normal saline placebo administered intravenously prior to surgery under standardized spinal anesthesia. Receives: Drug: Placebo (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Hemoglobin Mass Recovered in Irrigation Effluent
Total hemoglobin mass (grams) quantified from irrigation effluent collected during transurethral resection of the prostate as an objective measure of intraoperative blood loss.
Measured: During surgery (from start of resection to end of procedure, up to 3 hours)
Postoperative Hemoglobin Concentration
Systemic hemoglobin concentration (g/dL) measured 24 hours after transurethral resection of the prostate to assess perioperative hemoglobin preservation.
Measured: 24 hours after surgery
Secondary outcomes (5)
Perioperative Red Blood Cell Transfusion Requirement
Requirement for allogeneic red blood cell transfusion during the perioperative period according to institutional transfusion thresholds.
Measured: From surgery until hospital discharge (up to 7 days)
Operative Duration
Total duration of transurethral resection of the prostate measured in minutes from surgical start to completion.
Measured: During surgery (from skin incision to end of resection, up to 3 hours)
Duration of Bladder Catheterization
Number of days from surgery until removal of urinary bladder catheter.
Measured: From end of surgery until urinary catheter removal (up to 7 days)
Hospital Length of Stay
Total number of days from surgery to hospital discharge.
Measured: From end of surgery until hospital discharge (up to 14 days)
Perioperative Adverse Events
Occurrence of thromboembolic complications, seizures, or other serious adverse events during the perioperative period.
Measured: From surgery until hospital discharge (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start30 Mar 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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 are randomized in a 1:1 ratio to receive intravenous tranexamic acid or placebo prior to transurethral resection of the prostate under standardized spinal anesthesia.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamza Najout
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hamza Najout, Military Teaching Hospital Mohammed V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460518
- Sponsor's protocol ID
- HMIMV-TXA-TURP-2025
- Acronym
- TXA-TURP
- Status last verified
- Oct 2026
- First submitted
- 1 Mar 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for Perioperative Haemostatic Optimisation During Transurethral Resection of the Prostate: A Randomized Quadruple-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07460518
- Acronym / sponsor ID
- TXA-TURP / HMIMV-TXA-TURP-2025
- Conditions
- Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate, Perioperative Bleeding, Anemia, Postoperative
- Keywords
- Tranexamic Acid, TURP, Patient Blood Management, Spinal Anesthesia, Randomized Controlled Trial, Hemostasis, Enhanced Recovery After Surgery, Perioperative Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hamza NajoutUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 10 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.
Transurethral resection of the prostate (TURP) is commonly performed in elderly patients and may be associated with perioperative bleeding leading to postoperative anemia and delayed recovery. Tranexamic acid (TXA), an antifibrinolytic agent, may reduce surgical bleeding by inhibiting fibrin degradation.
This prospective randomized quadruple-blind placebo-controlled clinical trial evaluates whether perioperative administration of intravenous tranexamic acid reduces intraoperative blood loss and preserves postoperative hemoglobin concentration in patients undergoing TURP under standardized spinal anesthesia.
Participants are randomly assigned to receive either intravenous tranexamic acid or placebo prior to surgery. The primary outcomes assess objective measures of perioperative blood loss and postoperative hemoglobin levels. Secondary outcomes include recovery parameters, perioperative safety, and exploratory hospital-level economic impact.
The study aims to determine whether anesthesia-led haemostatic optimization using tranexamic acid improves perioperative physiological stability and recovery efficiency within an enhanced recovery framework.
Detailed description
This investigator-initiated, prospective, randomized, quadruple-blind, placebo-controlled clinical trial is conducted at Mohammed V Military Teaching Hospital, Rabat, Morocco.
The study evaluates tranexamic acid as a perioperative blood management intervention during transurethral resection of the prostate performed under standardized spinal anesthesia within an enhanced recovery pathway. TURP surgery is characterized by local fibrinolytic activation that may contribute to continuous microvascular bleeding. Tranexamic acid inhibits plasminogen activation and may therefore reduce intraoperative haemoglobin loss.
Eligible participants undergoing elective TURP are randomized in a 1:1 ratio to receive either intravenous tranexamic acid (10 mg/kg) administered prior to surgical resection or placebo. Allocation concealment and quadruple blinding include participants, care providers, investigators, and outcome assessors.
The study includes two complementary co-primary haemostatic endpoints:
- total haemoglobin mass recovered in irrigation effluent as an objective measure of intraoperative blood loss, and
- postoperative haemoglobin concentration measured at 24 hours.
Secondary outcomes evaluate perioperative recovery variables, transfusion requirement, hospital length of stay, adverse events, and exploratory health-economic impact from a hospital perspective.
A prespecified interim analysis evaluates feasibility, treatment effect estimation, and safety signals without early stopping rules. Final confirmatory analysis will be performed after completion of planned enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to receive intravenous tranexamic acid or placebo prior to transurethral resection of the prostate under standardized spinal anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Group | Experimental | Drug: Tranexamic AcidParticipants receive intravenous tranexamic acid (10 mg/kg) administered approximately 30 minutes before transurethral resection of the prostate under standardized spinal anesthesia. |
| Placebo Group | Placebo comparator | Drug: Placebo (Normal Saline)Participants receive an identical volume of normal saline placebo administered intravenously prior to surgery under standardized spinal anesthesia. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients aged 50 years or older
- Diagnosed with benign prostatic hyperplasia (BPH)
- Scheduled for elective transurethral resection of the prostate (TURP) under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Provided written informed consent
Key exclusion criteria (7 listed)
- History of thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke)
- Known hypersensitivity to tranexamic acid
- Severe renal impairment (creatinine clearance <30 mL/min)
- Coagulation disorders
- Current anticoagulant therapy not appropriately discontinued
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 AcidIntravenous tranexamic acid administered at a dose of 10 mg/kg approximately 30 minutes before surgical resection to reduce perioperative bleeding during transurethral resection of the prostate. | Drug | Tranexamic Acid Group |
| Placebo (Normal Saline)Intravenous administration of normal saline placebo prepared to be identical in appearance and volume to the tranexamic acid solution to maintain blinding. | Drug | Placebo Group |
Primary outcome
Total Hemoglobin Mass Recovered in Irrigation Effluent
Time frame: During surgery (from start of resection to end of procedure, up to 3 hours)
Total hemoglobin mass (grams) quantified from irrigation effluent collected during transurethral resection of the prostate as an objective measure of intraoperative blood loss.
Postoperative Hemoglobin Concentration
Time frame: 24 hours after surgery
Systemic hemoglobin concentration (g/dL) measured 24 hours after transurethral resection of the prostate to assess perioperative hemoglobin preservation.
5 secondary outcomes
Perioperative Red Blood Cell Transfusion Requirement
Time frame: From surgery until hospital discharge (up to 7 days)
Operative Duration
Time frame: During surgery (from skin incision to end of resection, up to 3 hours)
Duration of Bladder Catheterization
Time frame: From end of surgery until urinary catheter removal (up to 7 days)
Hospital Length of Stay
Time frame: From end of surgery until hospital discharge (up to 14 days)
Perioperative Adverse Events
Time frame: From surgery until hospital discharge (up to 30 days)
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 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Benign Prostatic Hyperplasia and Transurethral Resection of the Prostate, run by Hamza Najout at 1 site in Morocco.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 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 Morocco. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Hemoglobin Mass Recovered in Irrigation Effluent (time frame: During surgery (from start of resection to end of procedure, up to 3 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.