Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.

March 1, 2021 updated by: Diaa Eldin Taha Ramadan Mohamed, Kafrelsheikh University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Kafrelsheikh
      • Kafr Ash Shaykh, Kafrelsheikh, Egypt
        • Recruiting
        • Kafrelsheikh Faculty of Medicine
        • Sub-Investigator:
          • Hossam Nabeeh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the value of tranexamic acid
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin drop post PCNL.
Time Frame: 12 months
Assess fall percentage in hemoglobin drop.
12 months
Requirement of blood transfusion post PCNL.
Time Frame: 12 months
assess the total blood loss and requirement of blood transfusion post PCNL.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

April 18, 2020

First Submitted That Met QC Criteria

April 26, 2020

First Posted (ACTUAL)

April 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS/19.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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