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Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy

NCT07582341 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Stones
  • Surgical Blood Loss
  • Percutaneous Nephrolithotomy

Interventions

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.

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.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-30
Primary Completion
2026-04-15
Completion
2026-04-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07582341 on ClinicalTrials.gov