Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy

NCT07582341 | Completed Phase 4

• 1 other identifier: MS 33-5-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Kidney stones; Irrigation fluid; Blood loss; Blood transfusion; Tranexamic acid; Percutaneous nephrolithotomy; Renal stones; Surgical field visibility; Endoscopic visual clarity; Urologic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in hematocrit concentration after percutaneous nephrolithotomy

  Preoperative, immediate postoperative, and 24 hours postoperative

• Need for blood transfusion

  Intraoperatively and up to 24 hours postoperatively

• Hemoglobin concentration in irrigation fluid

  At the end of surgery

• Endoscopic surgical field visibility score

  At the end of surgery

• Postoperative Hematuria

  Up to 24 hours postoperatively

Study Arms (2)

Combined Tranexamic Acid Group

EXPERIMENTAL

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

Normal Saline Control Group

PLACEBO COMPARATOR

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

Interventions

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.

Combined Tranexamic Acid Group

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.

Normal Saline Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Kidney Calculi; Blood Loss, Surgical; Hemorrhage; Nephrolithiasis

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Model Details: Participants were randomly assigned to one of two parallel groups. The intervention group received tranexamic acid intravenously before anesthesia induction and locally in the irrigation fluid during percutaneous nephrolithotomy. The control group received normal saline intravenously and in the irrigation fluid.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: May 30, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available beginning 6 months after publication of the study results and will remain available for 2 years.
• 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.

Locations

EG (1)