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Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy

6. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Fase 4

Kontakter og lokationer

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Studiesteder

  • Egypten
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egypten, 13511
        • Benha University Hospital

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Placebo komparator: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in hemoglobin concentration after percutaneous nephrolithotomy
Tidsramme: Preoperative, immediate postoperative, and 24 hours postoperative
Difference in hemoglobin concentration measured before surgery and after surgery to assess perioperative blood loss.
Preoperative, immediate postoperative, and 24 hours postoperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in hematocrit concentration after percutaneous nephrolithotomy
Tidsramme: 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.
Preoperative, immediate postoperative, and 24 hours postoperative
Need for blood transfusion
Tidsramme: Intraoperatively and up to 24 hours postoperatively
Number of participants who required blood transfusion during the intraoperative or postoperative hospital stay period.
Intraoperatively and up to 24 hours postoperatively
Hemoglobin concentration in irrigation fluid
Tidsramme: 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.
At the end of surgery
Endoscopic surgical field visibility score
Tidsramme: 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.
At the end of surgery
Postoperative Hematuria
Tidsramme: Up to 24 hours postoperatively
Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy.
Up to 24 hours postoperatively
Need for Additional Hemostatic Intervention
Tidsramme: Up to 24 hours postoperatively
Number of participants who required an additional intervention to control bleeding after percutaneous nephrolithotomy.
Up to 24 hours postoperatively
Postoperative Infection
Tidsramme: Up to 24 hours postoperatively
Number of participants who developed postoperative infection after percutaneous nephrolithotomy.
Up to 24 hours postoperatively
Postoperative Hematuria
Tidsramme: Up to 24 hours postoperatively
Number of participants with visible hematuria requiring continued nephrostomy tube closure or delayed nephrostomy tube removal.
Up to 24 hours postoperatively

Samarbejdspartnere og efterforskere

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Sponsor

Benha University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. maj 2025

Primær færdiggørelse (Faktiske)

15. april 2026

Studieafslutning (Faktiske)

15. april 2026

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MS 33-5-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Data will become available beginning 6 months after publication of the study results and will remain available for 2 years.

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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