Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.
1 other identifier
interventional
200
1 country
1
Brief Summary
Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 18, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMarch 3, 2021
March 1, 2021
2 years
April 18, 2020
March 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Hemoglobin drop post PCNL.
12 months
Requirement of blood transfusion post PCNL.
12 months
Study Arms (2)
tranexamic acid local
ACTIVE COMPARATORtranexamic acid inside the irrigation fluid
tranexamic acid IV
ACTIVE COMPARATORtranexamic acid injection
Interventions
hemostatics use
Eligibility Criteria
You may qualify if:
- Patient 18 years or older
- Stones ≥ 2 cm and/or mild to moderate hydronephrosis.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kafrelsheikh faculty of medicine
Kafr ash Shaykh, Kafrelsheikh, Egypt
Related Publications (1)
Cleveland B, Norling B, Wang H, Gandhi V, Price CL, Borofsky MS, Pais V, Dahm P. Tranexamic acid for percutaneous nephrolithotomy. Cochrane Database Syst Rev. 2023 Oct 26;10(10):CD015122. doi: 10.1002/14651858.CD015122.pub2.
PMID: 37882229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diaa Eldin Taha, MD
Lecturer of urology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- randomization
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of urology
Study Record Dates
First Submitted
April 18, 2020
First Posted
April 29, 2020
Study Start
September 1, 2019
Primary Completion
September 1, 2021
Study Completion
March 1, 2022
Last Updated
March 3, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share