Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy

The Role of Tranexamic Acid Combined Dose Intravenous and in Irrigation Fluid in Optimizing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled and Double-blind Study

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.

Study Overview

• Status: Completed
• Conditions: Surgical Blood Loss; Kidney Stones; Percutaneous Nephrolithotomy
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Qalyubia Governorate
    • Banhā, Qalyubia Governorate, Egypt, 13511
      • Benha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Tranexamic Acid Group; Participants in this arm received tranexamic acid 10 milligrams per kilogram intravenously in 250 milliliters normal saline 15 minutes before induction of anesthesia, in addition to the same dose of tranexamic acid added to the first 4 liters of irrigation fluid during percutaneous nephrolithotomy.	Drug: Tranexamic acid; Tranexamic acid was administered as a combined intravenous and local intervention during percutaneous nephrolithotomy. The intravenous dose was given before anesthesia induction, and the local dose was added to the initial irrigation fluid used during the procedure.
Placebo Comparator: Normal Saline Control Group; Participants in this arm received 250 milliliters normal saline intravenously 15 minutes before induction of anesthesia, in addition to normal saline placebo added to the first 4 liters of irrigation fluid during percutaneous nephrolithotomy.	Drug: Normal Saline; Normal saline was used as the placebo comparator. It was administered intravenously before anesthesia induction and added to the initial irrigation fluid during percutaneous nephrolithotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin concentration after percutaneous nephrolithotomy	Difference in hemoglobin concentration measured before surgery and after surgery to assess perioperative blood loss.	Preoperative, immediate postoperative, and 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hematocrit concentration after percutaneous nephrolithotomy	Difference in hematocrit concentration measured before surgery and after surgery as an additional indicator of perioperative blood loss.	Preoperative, immediate postoperative, and 24 hours postoperative
Need for blood transfusion	Number of participants who required blood transfusion during the intraoperative or postoperative hospital stay period.	Intraoperatively and up to 24 hours postoperatively
Hemoglobin concentration in irrigation fluid	Hemoglobin concentration measured in the irrigation fluid collected at the end of surgery as an estimate of intraoperative blood loss.	At the end of surgery
Endoscopic surgical field visibility score	Surgical field visibility was assessed by the operating surgeon using a 10-point visual scale. The score ranges from 1 to 10, where 1 indicates very poor visibility and 10 indicates perfect visibility. Higher scores indicate better endoscopic surgical field visibility.	At the end of surgery
Postoperative Hematuria	Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy.	Up to 24 hours postoperatively
Need for Additional Hemostatic Intervention	Number of participants who required an additional intervention to control bleeding after percutaneous nephrolithotomy.	Up to 24 hours postoperatively
Postoperative Infection	Number of participants who developed postoperative infection after percutaneous nephrolithotomy.	Up to 24 hours postoperatively
Postoperative Hematuria	Number of participants with visible hematuria requiring continued nephrostomy tube closure or delayed nephrostomy tube removal.	Up to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2025
• Primary Completion (Actual): April 15, 2026
• Study Completion (Actual): April 15, 2026

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Tranexamic acid; Kidney stones; Renal stones; Blood loss; Percutaneous nephrolithotomy; Blood transfusion; Irrigation fluid; Urologic surgery; Surgical field visibility; Endoscopic visual clarity
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Nephrolithiasis; Hemorrhage; Blood Loss, Surgical; Organic Chemicals; Pharmaceutical Preparations; Carboxylic Acids; Crystalloid Solutions; Isotonic Solutions; Solutions; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid; Saline Solution
• Other Study ID Numbers: MS 33-5-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available beginning 6 months after publication of the study results and will remain available for 2 years.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No