Kidney StonesPhase 4NCT07582341
Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy
A Phase 4 study testing Tranexamic acid and Normal Saline in people with Kidney Stones and Surgical Blood Loss, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones, Surgical Blood Loss, Percutaneous Nephrolithotomy
- What is being tested?
- Tranexamic acid and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2025to 15 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older.
- Patients with primary renal stones larger than 2 cm.
- Patients scheduled for elective percutaneous nephrolithotomy (PCNL).
Who cannot join
- Morbid obesity.
- Known renal anatomical anomalies or a solitary functioning kidney.
- Severe hydronephrosis affecting renal parenchymal thickness.
- Known hypersensitivity to tranexamic acid.
- Active coagulopathy.
- Current anticoagulant or antiplatelet therapy.
Show all 10Show fewer
- History of hematological or thromboembolic disease.
- Chronic renal or hepatic impairment.
- Active uncontrolled urinary tract infection.
- American Society of Anesthesiologists (ASA) physical status class III or higher.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Being tested
- Tranexamic acid, Normal Saline
- Keywords
- Kidney stones, Irrigation fluid, Blood loss, Blood transfusion, Tranexamic acid, Percutaneous nephrolithotomy, Renal stones, Surgical field visibility, Endoscopic visual clarity, Urologic surgery
- Medical subject headings
- Kidney Calculi, Blood Loss, Surgical, Hemorrhage, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
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 SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin concentration after percutaneous nephrolithotomy
Estimated intraoperative blood loss (mL) during percutaneous nephrolithotomy, calculated using the hemoglobin concentration measured in the collected and homogenized irrigation effluent and the total volume of collected fluid. All irrigation effluent, urethral catheter drainage, and blood clots were collected throughout the procedure, and a representative sample was analyzed for hemoglobin concentration. Lower estimated blood loss indicates less intraoperative bleeding.
Measured: Intraoperatively, assessed at the end of surgery.
Secondary outcomes (13)
Change in Hematocrit After Percutaneous Nephrolithotomy
Change in hematocrit, expressed in percentage points, calculated as the difference between hematocrit measured within 24 hours before surgery and 24 hours after surgery. Negative values indicate a postoperative reduction in hematocrit.
Measured: Within 24 hours preoperatively and at 24 hours postoperatively.
Need for blood transfusion
Number of participants requiring blood transfusion during or after percutaneous nephrolithotomy. Transfusion requirement was recorded according to the patient's clinical condition and laboratory findings.
Measured: 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.
Measured: At the end of surgery
Intraoperative Endoscopic Surgical Field Visibility Score
Endoscopic surgical field visibility was assessed by the operating surgeon at the end of percutaneous nephrolithotomy using a subjective 10-point numerical rating scale representing overall visualization throughout the procedure. Scores range from 1 (worst visibility) to 10 (best attainable visibility), with higher scores indicating better surgical field clarity. The scale has not been formally validated for percutaneous nephrolithotomy.
Measured: At the end of surgery
Postoperative Hematuria
Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy.
Measured: Up to 24 hours postoperatively
Number of Participants Requiring Additional Hemostatic Intervention
Number of participants requiring additional therapeutic or procedural intervention to control bleeding during or after percutaneous nephrolithotomy, beyond routine intraoperative hemostatic measures. Additional interventions were recorded according to the clinical and surgical documentation.
Measured: Intraoperatively and up to 24 hours postoperatively.
Number of Participants With Postoperative Infection
Number of participants who developed postoperative infection after percutaneous nephrolithotomy.
Measured: Up to 24 hours postoperatively
Postoperative Hematuria
Number of participants with visible hematuria requiring continued nephrostomy tube closure or delayed nephrostomy tube removal.
Measured: Up to 24 hours postoperatively
Change in Hemoglobin Concentration
Change in Hemoglobin Concentration After Percutaneous Nephrolithotomy
Description: Change in blood hemoglobin concentration (g/dL), calculated as the difference between hemoglobin measured within 24 hours before surgery and 24 hours after surgery. Negative values indicate a postoperative reduction in hemoglobin concentration.
Measured: Within 24 hours preoperatively and at 24 hours postoperatively.
Total Intraoperative Irrigation Fluid Volume
Total volume of irrigation fluid used during percutaneous nephrolithotomy, measured in liters (L). Irrigation volume was recorded throughout the procedure for each participant.
Measured: Intraoperatively, assessed at the end of surgery.
Number of Participants With Residual Renal Stones Following Percutaneous Nephrolithotomy
Number of participants with residual renal stones identified during postoperative assessment following percutaneous nephrolithotomy. Residual stone status and the requirement for subsequent stone-management procedures were recorded.
Measured: 24 hours postoperatively
Postoperative Length of Hospital Stay
Duration of postoperative hospitalization, measured in days from the date of percutaneous nephrolithotomy to hospital discharge.
Measured: From the day of surgery until hospital discharge (postoperative days 1-3).
Postoperative Fever
Number of participants who developed documented postoperative fever following percutaneous nephrolithotomy, based on postoperative temperature monitoring and clinical records. Fever was recorded separately from confirmed postoperative infection.
Measured: From completion of surgery through 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start30 Jun 2025
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Hassan Mohamed Mandour, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582341
- Sponsor's protocol ID
- MS 33-5-2025
- Status last verified
- Oct 2026
- First submitted
- 6 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07582341
- Acronym / sponsor ID
- MS 33-5-2025
- Keywords
- Kidney stones, Irrigation fluid, Blood loss, Blood transfusion, Tranexamic acid, Percutaneous nephrolithotomy, Renal stones, Surgical field visibility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Combined Tranexamic Acid Group | Experimental | Drug: Tranexamic acidParticipants 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. |
| Normal Saline Control Group | Placebo comparator | Drug: Normal SalineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 years or older.
- Patients with primary renal stones larger than 2 cm.
- Patients scheduled for elective percutaneous nephrolithotomy (PCNL).
Key exclusion criteria (10 listed)
- Morbid obesity.
- Known renal anatomical anomalies or a solitary functioning kidney.
- Severe hydronephrosis affecting renal parenchymal thickness.
- Known hypersensitivity to tranexamic acid.
- Active coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidTranexamic 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 | Combined Tranexamic Acid Group |
| Normal SalineNormal saline was used as the placebo comparator. It was administered intravenously before anesthesia induction and added to the initial irrigation fluid during percutaneous nephrolithotomy. | Drug | Normal Saline Control Group |
Primary outcome
Change in hemoglobin concentration after percutaneous nephrolithotomy
Time frame: Intraoperatively, assessed at the end of surgery.
Estimated intraoperative blood loss (mL) during percutaneous nephrolithotomy, calculated using the hemoglobin concentration measured in the collected and homogenized irrigation effluent and the total volume of collected fluid. All irrigation effluent, urethral catheter drainage, and blood clots were collected throughout the procedure, and a representative sample was analyzed for hemoglobin concentration. Lower estimated blood loss indicates less intraoperative bleeding.
13 secondary outcomes
Change in Hematocrit After Percutaneous Nephrolithotomy
Time frame: Within 24 hours preoperatively and at 24 hours postoperatively.
Need for blood transfusion
Time frame: Intraoperatively and up to 24 hours postoperatively.
Hemoglobin concentration in irrigation fluid
Time frame: At the end of surgery
Intraoperative Endoscopic Surgical Field Visibility Score
Time frame: At the end of surgery
Postoperative Hematuria
Time frame: Up to 24 hours postoperatively
Number of Participants Requiring Additional Hemostatic Intervention
Time frame: Intraoperatively and up to 24 hours postoperatively.
Number of Participants With Postoperative Infection
Time frame: Up to 24 hours postoperatively
Postoperative Hematuria
Time frame: Up to 24 hours postoperatively
Change in Hemoglobin Concentration
Time frame: Within 24 hours preoperatively and at 24 hours postoperatively.
Total Intraoperative Irrigation Fluid Volume
Time frame: Intraoperatively, assessed at the end of surgery.
Number of Participants With Residual Renal Stones Following Percutaneous Nephrolithotomy
Time frame: 24 hours postoperatively
Postoperative Length of Hospital Stay
Time frame: From the day of surgery until hospital discharge (postoperative days 1-3).
Postoperative Fever
Time frame: From completion of surgery through 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid and Normal Saline in people with Kidney Stones and Surgical Blood Loss, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin concentration after percutaneous nephrolithotomy (time frame: Intraoperatively, assessed at the end of surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.