Perioperative Bleeding During Recurrent Hypospadias RepairNCT07778992
Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
A study testing single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg) in people with Perioperative Bleeding During Recurrent Hypospadias Repair, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
This study aims to fill that gap by evaluating the efficacy and safety of intravenous TXA in children undergoing redo hypospadias surgery, potentially establishing a new standard of care Read more about this study
- Who is it for?
- Ages 1 year to 10 years, men only
- Conditions the study is for
- Perioperative Bleeding During Recurrent Hypospadias Repair
- What is being tested?
- single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Oct 2026
- Phase
- Interventional
- 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 1 year to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Male children aged 1 year to 10 years Scheduled for surgical repair of recurrent hypospadias Classified as ASA physical status I or II.
Who cannot join
- Known personal or family history of bleeding disorders or thrombophilia. Documented history of seizures or epilepsy. Known allergy or hypersensitivity to tranexamic acid. Concurrent use of anticoagulant medications or other antifibrinolytics. Significant renal impairment (eGFR < 60 mL/min/1.73m²).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair - A Randomized Controlled Trial
This study aims to fill that gap by evaluating the efficacy and safety of intravenous TXA in children undergoing redo hypospadias surgery, potentially establishing a new standard of care
- Being tested
- single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg), Control (Normal saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)Drug
single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)
Control (Normal saline)Drug
Participants in the control group will receive an equivalent volume (20cc) of 0.9% normal saline solution, prepared in an identical syringe by the pharmacy. It will be administered intravenously in the same manner and over the same duration as the intervention drug to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Placebo comparator | Participants in the control group will receive an equivalent volume (20cc) of 0.9% normal saline solution, prepared in an identical syringe by the pharmacy Receives: Drug: Control (Normal saline) |
| Intervention Group (TXA) | Experimental | single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg) Receives: Drug: single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative blood loss
This will be quantified using the gravimetric method. All surgical sponges and gauzes will be weighed before use and after being soaked with blood. The difference in weight (1 gram = 1 mL of blood) will be summed to calculate the total blood loss. Suctioned fluids will be measured, and the amount of irrigation fluid used will be subtracted to determine the volume of blood loss collected via suction.
Measured: INTRAOPERATIVE
Secondary outcomes (4)
Surgical field visibility
Assessed intraoperatively by the primary surgeon at predefined intervals using the Fromme scale (also known as the Boezaart scale), a validated 5-point scale ranging from 0 (no bleeding) to 4 (severe bleeding, surgery not possible).
Measured: INTRAOPERATIVE
Surgeon satisfaction with the surgical field visibility
To be assessed post- operatively using a 5-point Likert scale (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied).
Measured: INTRAOPERATIVE
Total operative time
Measured in minutes from the time of skin incision to the application of the final dressing.
Measured: INTRAOPERATIVE
Incidence of postoperative bleeding complications
Defined as the occurrence of a clinically significant hematoma (requiring drainage or causing wound compromise) or other bleeding event requiring intervention within 7 days of surgery.
Measured: within 7 days of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Mar 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Bleeding During Recurrent Hypospadias RepairStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tarek Sayed Hemaida, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778992
- Sponsor's protocol ID
- 1218/2/26
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07778992
- Acronym / sponsor ID
- 1218/2/26
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 21 Aug 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 aims to fill that gap by evaluating the efficacy and safety of intravenous TXA in children undergoing redo hypospadias surgery, potentially establishing a new standard of care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | Placebo comparator | Drug: Control (Normal saline)Participants in the control group will receive an equivalent volume (20cc) of 0.9% normal saline solution, prepared in an identical syringe by the pharmacy |
| Intervention Group (TXA) | Experimental | Drug: single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg) |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Male children aged 1 year to 10 years Scheduled for surgical repair of recurrent hypospadias Classified as ASA physical status I or II.
Key exclusion criteria (1 listed)
- Known personal or family history of bleeding disorders or thrombophilia. Documented history of seizures or epilepsy. Known allergy or hypersensitivity to tranexamic acid. Concurrent use of anticoagulant medications or other antifibrinolytics. Significant renal impairment (eGFR < 60 mL/min/1.73m²).
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 |
|---|---|---|
| single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg) | Drug | Intervention Group (TXA) |
| Control (Normal saline)Participants in the control group will receive an equivalent volume (20cc) of 0.9% normal saline solution, prepared in an identical syringe by the pharmacy. It will be administered intravenously in the same manner and over the same duration as the intervention drug to maintain blinding. | Drug | CONTROL GROUP |
Primary outcome
Total intraoperative blood loss
Time frame: INTRAOPERATIVE
This will be quantified using the gravimetric method. All surgical sponges and gauzes will be weighed before use and after being soaked with blood. The difference in weight (1 gram = 1 mL of blood) will be summed to calculate the total blood loss. Suctioned fluids will be measured, and the amount of irrigation fluid used will be subtracted to determine the volume of blood loss collected via suction.
4 secondary outcomes
Surgical field visibility
Time frame: INTRAOPERATIVE
Surgeon satisfaction with the surgical field visibility
Time frame: INTRAOPERATIVE
Total operative time
Time frame: INTRAOPERATIVE
Incidence of postoperative bleeding complications
Time frame: within 7 days of 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 21 Aug 2026.
- Individual participant dataSharing planned: No
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 study testing single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg) in people with Perioperative Bleeding During Recurrent Hypospadias Repair, run by Aswan University Hospital at 1 site in Egypt.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 21 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 Egypt. 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.
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?
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?
Total intraoperative blood loss (time frame: INTRAOPERATIVE). 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 21 Aug 2026.