Percutaneous nephrolithotomy is a minimally invasive surgical procedure used to remove large kidney stones. Although it is an effective treatment, bleeding during and after the procedure remains one of the main concerns and may sometimes require blood transfusion.

Tranexamic acid is a medication that helps reduce bleeding by limiting the breakdown of blood clots. It can be given through a vein and may also be used locally in irrigation fluid during surgery. This study evaluates whether using tranexamic acid by both routes during percutaneous nephrolithotomy can reduce blood loss, improve the clarity of the surgical field during endoscopy, and reduce the need for blood transfusion.

The study included adult patients with kidney stones larger than two centimeters who were suitable for percutaneous nephrolithotomy. Patients were randomly assigned to receive either tranexamic acid through a vein and in the irrigation fluid, or normal saline as a control treatment. Blood loss was assessed using hemoglobin and hematocrit levels before and after surgery, as well as hemoglobin concentration in the irrigation fluid collected at the end of the operation. The surgeon also assessed the clarity of the surgical field using a ten-point visual scale.

The hypothesis of the study is that combined intravenous and local administration of tranexamic acid in irrigation fluid during percutaneous nephrolithotomy reduces blood loss, improves surgical visibility, and lowers the need for blood transfusion compared with normal saline.

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.

Deidentified individual participant data related to the study outcomes will be available for sharing. The shared data may include baseline characteristics, operative data, hemoglobin and hematocrit measurements, blood transfusion data, irrigation fluid hemoglobin concentration, surgical field visibility score, and recorded postoperative outcomes.

Data will become available beginning 6 months after publication of the study results and will remain available for 2 years.

Data will be available upon reasonable request from qualified researchers for scientific purposes. Requests will be reviewed by the study investigators, and data will be shared after approval and completion of a data use agreement.

The study was double-blinded. Participants, care providers, investigators, and outcome assessors were masked to group allocation. Tranexamic acid and placebo were prepared in a similar manner, with normal saline used as placebo in the control group.