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NCT04367155 Clinical Trial

Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.

Nephrolithiasis Clinical Trial

Official title:
Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. a Double-blind, Placebo-controlled Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04367155
Other study ID # RS/19.22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date March 1, 2022

Study information
Verified date March 2021
Source Kafrelsheikh University
Contact Diaa Eldin Taha, MD
Phone 01008531384
Email drdiaaeldin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.

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 information / eligibility
Status Recruiting
Enrollment 200
Est. completion date March 1, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic acid injection
hemostatics use

Locations
Country Name City State
Egypt Kafrelsheikh faculty of medicine Kafr Ash Shaykh Kafrelsheikh

Sponsors (1)
Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the value of tranexamic acid 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. 12 months
Secondary Hemoglobin drop post PCNL. Assess fall percentage in hemoglobin drop. 12 months
Secondary Requirement of blood transfusion post PCNL. assess the total blood loss and requirement of blood transfusion post PCNL. 12 months
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