Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy
6 mei 2026 bijgewerkt door: Hossam Hassan Mohamed Mandour, Benha University
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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
90
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, Egypte, 13511
- Benha University Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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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.
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Placebo-vergelijker: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in hemoglobin concentration after percutaneous nephrolithotomy
Tijdsspanne: Preoperative, immediate postoperative, and 24 hours postoperative
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Difference in hemoglobin concentration measured before surgery and after surgery to assess perioperative blood loss.
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Preoperative, immediate postoperative, and 24 hours postoperative
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in hematocrit concentration after percutaneous nephrolithotomy
Tijdsspanne: Preoperative, immediate postoperative, and 24 hours postoperative
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Difference in hematocrit concentration measured before surgery and after surgery as an additional indicator of perioperative blood loss.
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Preoperative, immediate postoperative, and 24 hours postoperative
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Need for blood transfusion
Tijdsspanne: Intraoperatively and up to 24 hours postoperatively
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Number of participants who required blood transfusion during the intraoperative or postoperative hospital stay period.
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Intraoperatively and up to 24 hours postoperatively
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Hemoglobin concentration in irrigation fluid
Tijdsspanne: At the end of surgery
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Hemoglobin concentration measured in the irrigation fluid collected at the end of surgery as an estimate of intraoperative blood loss.
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At the end of surgery
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Endoscopic surgical field visibility score
Tijdsspanne: At the end of surgery
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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.
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At the end of surgery
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Postoperative Hematuria
Tijdsspanne: Up to 24 hours postoperatively
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Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Need for Additional Hemostatic Intervention
Tijdsspanne: Up to 24 hours postoperatively
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Number of participants who required an additional intervention to control bleeding after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Postoperative Infection
Tijdsspanne: Up to 24 hours postoperatively
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Number of participants who developed postoperative infection after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Postoperative Hematuria
Tijdsspanne: Up to 24 hours postoperatively
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Number of participants with visible hematuria requiring continued nephrostomy tube closure or delayed nephrostomy tube removal.
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Up to 24 hours postoperatively
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
30 mei 2025
Primaire voltooiing (Werkelijk)
15 april 2026
Studie voltooiing (Werkelijk)
15 april 2026
Studieregistratiedata
Eerst ingediend
6 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
6 mei 2026
Eerst geplaatst (Werkelijk)
12 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
6 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Pathologische processen
- Mannelijke urogenitale ziekten
- Berekeningen
- Pathologische aandoeningen, anatomisch
- Nier Ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Urolithiase
- Urinewegen
- Intraoperatieve complicaties
- Pathologische aandoeningen, tekenen en symptomen
- Nierstenen
- Nefrolithiase
- Bloeding
- Bloedverlies, chirurgisch
- Organische chemicaliën
- Farmaceutische voorbereidingen
- Carbonzuren
- Crystalloid -oplossingen
- Isotone oplossingen
- Oplossingen
- Zuren, carbocyclisch
- Cyclohexanecarbonzuren
- Tranexaminezuur
- Zoutoplossing
Andere studie-ID-nummers
- MS 33-5-2025
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
Data will become available beginning 6 months after publication of the study results and will remain available for 2 years.
IPD-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .