Back to resultsEfficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.
Primary Purpose
Renal Stones, Nephrolithiasis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic acid injection
Sponsored by
About this trial
This is an interventional treatment trial for Renal Stones focused on measuring Tranexamic acid, percutanous nephrolithotomy
Eligibility Criteria
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
Sites / Locations
- Kafrelsheikh faculty of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
tranexamic acid local
tranexamic acid IV
Arm Description
tranexamic acid inside the irrigation fluid
tranexamic acid injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Hemoglobin drop post PCNL.
Assess fall percentage in hemoglobin drop.
Requirement of blood transfusion post PCNL.
assess the total blood loss and requirement of blood transfusion post PCNL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04367155
Brief Title
Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.
Official Title
Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. a Double-blind, Placebo-controlled Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stones, Nephrolithiasis
Keywords
Tranexamic acid, percutanous nephrolithotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
tranexamic acid during and after percutanous nephrolithotomy procedure
Masking
Care ProviderOutcomes Assessor
Masking Description
randomization
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tranexamic acid local
Arm Type
Active Comparator
Arm Description
tranexamic acid inside the irrigation fluid
Arm Title
tranexamic acid IV
Arm Type
Active Comparator
Arm Description
tranexamic acid injection
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Other Intervention Name(s)
tranexamic acid 500 mg
Intervention Description
hemostatics use
Primary Outcome Measure Information:
Title
To assess the value of tranexamic acid
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hemoglobin drop post PCNL.
Description
Assess fall percentage in hemoglobin drop.
Time Frame
12 months
Title
Requirement of blood transfusion post PCNL.
Description
assess the total blood loss and requirement of blood transfusion post PCNL.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diaa Eldin Taha, MD
Phone
01008531384
Email
drdiaaeldin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hossam Nabeeh, MD
Email
dr_hossam_nabeeh@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diaa Eldin Taha, MD
Organizational Affiliation
Lecturer of urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafrelsheikh faculty of medicine
City
Kafr Ash Shaykh
State/Province
Kafrelsheikh
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diaa ELDIN Taha, MD
Phone
01008531384
Email
drdiaaeldin@gmail.com
First Name & Middle Initial & Last Name & Degree
Hossam Nabeeh, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.
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