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NCT Number: NCT07582341

Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

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.

normal saline

Drug

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.

Primary outcomes

  1. Change in hemoglobin concentration after percutaneous nephrolithotomy

    Time frame: Preoperative, immediate postoperative, and 24 hours postoperative

    Difference in hemoglobin concentration measured before surgery and after surgery to assess perioperative blood loss.

Secondary outcomes

  1. Change in hematocrit concentration after percutaneous nephrolithotomy

    Time frame: Preoperative, immediate postoperative, and 24 hours postoperative

    Difference in hematocrit concentration measured before surgery and after surgery as an additional indicator of perioperative blood loss.

  2. Need for blood transfusion

    Time frame: Intraoperatively and up to 24 hours postoperatively

    Number of participants who required blood transfusion during the intraoperative or postoperative hospital stay period.

  3. Hemoglobin concentration in irrigation fluid

    Time frame: At the end of surgery

    Hemoglobin concentration measured in the irrigation fluid collected at the end of surgery as an estimate of intraoperative blood loss.

  4. Endoscopic surgical field visibility score

    Time frame: At the end of surgery

    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.

  5. Postoperative Hematuria

    Time frame: Up to 24 hours postoperatively

    Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy.

  6. Need for Additional Hemostatic Intervention

    Time frame: Up to 24 hours postoperatively

    Number of participants who required an additional intervention to control bleeding after percutaneous nephrolithotomy.

  7. Postoperative Infection

    Time frame: Up to 24 hours postoperatively

    Number of participants who developed postoperative infection after percutaneous nephrolithotomy.

  8. Postoperative Hematuria

    Time frame: Up to 24 hours postoperatively

    Number of participants with visible hematuria requiring continued nephrostomy tube closure or delayed nephrostomy tube removal.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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