Can a single drug dose make repeat hypospadias surgery safer?
NCT ID NCT07778992
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This trial tests whether a single intravenous dose of tranexamic acid, a drug that helps blood clot, can reduce bleeding during repeat hypospadias repair in boys aged 1 to 10 years. Half the children will receive the drug, and half will receive a placebo (salt water). The study measures total blood loss during surgery and how well the surgeon can see the surgical area, aiming to see if the drug improves safety and outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tranexamic acid (TXA) given as a single intravenous dose
- What this could lead to
- If effective, a single dose of tranexamic acid could become a standard way to reduce bleeding and improve surgical visibility during repeat hypospadias repair in children.
- What could go wrong
- This is a small, early-stage trial, and the drug may not significantly reduce bleeding. There are also potential risks like seizures or allergic reactions, though these are rare.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
44 people
The number who actually took part.
- Started
-
Mar 2026
- Expected to finish
-
Oct 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 year to 10 years
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Male children aged 1 year to 10 years Scheduled for surgical repair of recurrent hypospadias Classified as ASA physical status I or II. Exclusion Criteria: 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Perioperative bleeding during recurrent hypospadias repair are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Aswan University Hospital
Aswān, Egypt