Nephrolithiasis, Renal Stones
Conditions
Keywords
Tranexamic acid, percutanous nephrolithotomy
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.
Interventions
DRUGTranexamic acid injection
hemostatics use
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
randomization
Intervention model description
tranexamic acid during and after percutanous nephrolithotomy procedure
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Contacts
Primary ContactDiaa Eldin Taha, MD
Backup ContactHossam Nabeeh, MD
Outcome results
None listed