Impact of Tranexamic Acid Use in Percutaneous Nephrolithotomy

May 29, 2018 updated by: Carlos Alfredo Batagello, University of Sao Paulo

Impact of Tranexamic Acid Use in Transfusion Rate in Patients With Complex Kidney Stone Undergoing Percutaneous Nephrolithotomy: Randomised, Double-blind, Placebo Controlled Trial

This study is a double blinded randomized controlled trial evaluating the impact of tranexamic acid use on the transfusion rate in patients with complex kidney stones undergoing percutaneous nephrolithotomy.

Study Overview

Status

Unknown

Detailed Description

Introduction: Kidney stone is a high incidence and prevalent disease affecting people around the world. Nearly 1 in 11 individuals in the United States will be affected at some point in their lives. Furthermore, stones are likely to recur with at least 50% of individuals experiencing another stone within 10 years of the first occurrence. Moreover, the disease mainly affects the economically active segment of the population with special social and economic implications in health.

Approximately 85% of stones are composed predominantly by calcium compounds and about 7% are attributed to urinary tract infections, named struvite stones, that usually develop as jagged structures called "staghorns" and can grow to be quite large, therefore becoming complex kidney stone. However, in HCFMUSP, as a Brazilian national reference center in urolithiasis treatment, this complex stones represents about 30 percent of all renal lithiasis treated.

This complex stones require individualized and specialized treatment, with percutaneous nephrolithotomy (PCNL) as the standard of care, with advantages of higher stone clearance and cost-effectiveness when compared with other treatment alternatives.

However, PCNL is associated with significant morbidity such as fever, urinary infections, septicemia and bleeding that may require blood transfusion. Of these complications bleeding is the most unpredictable and dreaded, and can lead to significant morbidity, beyond the potential risks of blood transfusions by itself.

In this way antifibrinolytic drugs, such as tranexamic acid, have been shown to reduce blood loss in a variety of surgical procedures, blood transfusion rate, morbidity and mortality related to bleeding.

Objectives: The main outcome measure of our study is to evaluate the impact of tranexamic acid use in blood transfusion rate in patients with complex kidney stones undergoing PCNL (number of patients receiving blood transfusions from surgery until hospital discharge). The secondary outcome is to evaluate blood loss by hemoglobin measure, surgical time, stone free rate and complications. Furthermore, we want to corroborate the drug safety, previously established in the medical literature.

Methods: After protocol approval by the hospital ethics committee, patients undergoing PCNL for complex renal stone (GUYS classification III and IV) and who provided written informed consent, will be eligible for the trial. After the patients' eligibility is confirmed, we will randomly allocate them to the intervention or placebo group by a computer program. Trial participants, care providers, surgeons, the anesthesiology team and data collectors will be blinded to group assignments. Patients will be managed with surgical standardized technique by Endourological HCFMUSP group and controlled care after surgery. Blood transfusion rate, hemoglobin drop and complications will be evaluated at 7, 30, 90 and 180 days after surgery. On postoperative day one, CT scan will be performed to assess stone free rate and complications.

Study Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

      • Sao Paulo, Brazil, 05403-000

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complex kidney stone (staghorn calculi GUYS III and IV)

Exclusion Criteria:

  • Coronary artery disease - stent
  • Severe chronic renal failure
  • Congenital or acquired thrombophilia/thrombosis event
  • Known or suspected allergy

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: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tranexamic Acid Group
Tranexamic acid 1g IV during anesthesiology induction, single dose
PLACEBO_COMPARATOR: Placebo group
normal saline 1g IV during anesthesiology induction, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood transfusion rate
Time Frame: two years
postoperative follow up
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: two years
postoperative follow up
two years
surgical time
Time Frame: two years
postoperative follow up
two years
stone free rate
Time Frame: two years
postoperative follow up
two years
complications
Time Frame: two years
postoperative follow up
two years

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

June 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (ESTIMATE)

November 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 29, 2018

Last Verified

May 1, 2018

More Information

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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