Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.
- Registration Number
- NCT04367155
- Lead Sponsor
- Kafrelsheikh University
- Brief Summary
Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.
- Detailed Description
To evaluate whether intravenous tranexamic acid or tranexamic acid in the irrigation fluid in percutaneous nephrolithotomy (PCNL) in reducing bleeding during and after PCNL.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Patient 18 years or older
- Stones ≥ 2 cm and/or mild to moderate hydronephrosis.
Exclusion Criteria
- Age <18 years or Pregnancy
- Bilateral simultaneous PCNL
- Morbid obesity (BMI >40)
- Refuse to complete study requirements
- Untreated UTI
- Atypical bowel interposition by CT
- Tumour in the presumptive access tract area or Potential malignant kidney tumour
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tranexamic acid local Tranexamic acid injection tranexamic acid inside the irrigation fluid tranexamic acid IV Tranexamic acid injection tranexamic acid injection
- Primary Outcome Measures
Name Time Method To assess the value of tranexamic acid 12 months To compare the efficacy and safety of 0.1% IV tranexamic acid versus inside the irrigant fluid tranexamic acid in reducing blood loss during PCNL. Moreover, to assess the adverse events of tranexamic acid.
- Secondary Outcome Measures
Name Time Method Hemoglobin drop post PCNL. 12 months Assess fall percentage in hemoglobin drop.
Requirement of blood transfusion post PCNL. 12 months assess the total blood loss and requirement of blood transfusion post PCNL.
Trial Locations
- Locations (1)
Kafrelsheikh faculty of medicine
🇪🇬Kafr Ash Shaykh, Kafrelsheikh, Egypt