Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.

Sponsor
Kafrelsheikh University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04367155
Collaborator
(none)
200
1
2
30
6.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic acid injection
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
tranexamic acid during and after percutanous nephrolithotomy proceduretranexamic acid during and after percutanous nephrolithotomy procedure
Masking:
Double (Care Provider, Outcomes Assessor)
Masking Description:
randomization
Primary Purpose:
Treatment
Official Title:
Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. a Double-blind, Placebo-controlled Randomized Clinical Trial.
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: tranexamic acid local

tranexamic acid inside the irrigation fluid

Drug: Tranexamic acid injection
hemostatics use
Other Names:
  • tranexamic acid 500 mg
  • Active Comparator: tranexamic acid IV

    tranexamic acid injection

    Drug: Tranexamic acid injection
    hemostatics use
    Other Names:
  • tranexamic acid 500 mg
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Hemoglobin drop post PCNL. [12 months]

      Assess fall percentage in hemoglobin drop.

    2. Requirement of blood transfusion post PCNL. [12 months]

      assess the total blood loss and requirement of blood transfusion post PCNL.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kafrelsheikh faculty of medicine Kafr Ash Shaykh Kafrelsheikh Egypt

    Sponsors and Collaborators

    • Kafrelsheikh University

    Investigators

    • Principal Investigator: Diaa Eldin Taha, MD, Lecturer of urology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Diaa Eldin Taha Ramadan Mohamed, Lecturer of urology, Kafrelsheikh University
    ClinicalTrials.gov Identifier:
    NCT04367155
    Other Study ID Numbers:
    • RS/19.22
    First Posted:
    Apr 29, 2020
    Last Update Posted:
    Mar 3, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Diaa Eldin Taha Ramadan Mohamed, Lecturer of urology, Kafrelsheikh University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 3, 2021