Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy
6 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
90
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Qalyubia Governorate
-
Banhā, Qalyubia Governorate, Egypten, 13511
- Benha University Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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-jämförare: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in hemoglobin concentration after percutaneous nephrolithotomy
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in hematocrit concentration after percutaneous nephrolithotomy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 24 hours postoperatively
|
Number of participants who developed postoperative infection after percutaneous nephrolithotomy.
|
Up to 24 hours postoperatively
|
|
Postoperative Hematuria
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 maj 2025
Primärt slutförande (Faktisk)
15 april 2026
Avslutad studie (Faktisk)
15 april 2026
Studieregistreringsdatum
Först inskickad
6 maj 2026
Först inskickad som uppfyllde QC-kriterierna
6 maj 2026
Första postat (Faktisk)
12 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Calculi
- Patologiska tillstånd, anatomiska
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urolithiasis
- Urinvägar
- Intraoperativa komplikationer
- Patologiska tillstånd, tecken och symtom
- Njure Calculi
- Nefrolitiasis
- Blödning
- Blodförlust, kirurgiskt
- Organiska kemikalier
- Farmaceutiska förberedelser
- Karboxylsyror
- Kristalloidlösningar
- Isotonlösningar
- Lösningar
- Syror, karbocyklisk
- Cyklohexanekarboxylsyror
- Tranexaminsyra
- Saltlösning
Andra studie-ID-nummer
- MS 33-5-2025
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Data will become available beginning 6 months after publication of the study results and will remain available for 2 years.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .