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Drug cuts bleeding risk in kidney stone surgery

NCT ID NCT07582341

Disease control Sponsor: Benha University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving tranexamic acid, a drug that helps blood clot, through a vein and in surgical fluid can reduce bleeding during kidney stone removal. 90 adults with large kidney stones were randomly assigned to receive the drug or a placebo. The goal was to see if it lowers blood loss, improves the surgeon's view, and reduces the need for blood transfusions.

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
What this could lead to
If it works, this could make kidney stone surgery safer by reducing blood loss and the need for blood transfusions.
What could go wrong
This is a small, single-center study with 90 participants. Results may not apply to all patients, and tranexamic acid can rarely cause allergic reactions or blood clots.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

90 people

The number who actually took part.

Started

May 2025

Finished

Apr 2026

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

18 to 70 years

Sex

Anyone

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients aged 18 to 70 years. * Patients with renal stones larger than 2 centimeters. * Patients scheduled for percutaneous nephrolithotomy. * Normal renal function, defined as serum creatinine less than or equal to 1.5 milligrams per deciliter. * American Society of Anesthesiologists physical status class 1 or 2. Exclusion Criteria: * Hypersensitivity to tranexamic acid. * Pregnancy. * Current anticoagulation therapy. * Untreated urinary tract infection or urosepsis. * Renal anatomical anomalies, including ectopic kidney, duplex collecting system, or horseshoe kidney. * Solitary functioning kidney. * Decompensated coagulopathy or known hematological disease. * Acute or chronic renal disease. * History of cerebrovascular events or thromboembolism. * Uncontrolled arrhythmia. * Morbid obesity.

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical Hemorrhage Kidney Calculi nephrolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney stones Percutaneous nephrolithotomy Surgical blood loss

Contacts and locations

Locations

  • Benha University Hospital

    Banhā, Qalyubia Governorate, 13511, Egypt

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