Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements

May 3, 2023 updated by: GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

Efficacy of Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements at Centro Medico de Occidente'

Tranexamic acid in debridement surgery of burns on the volume of bleeding in transfusion requirements

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized, double-blind, prospective trial was conducted to establish the effect of intraoperative tranexamic acid in the early surgical debridement of severe burns. The study was carried out between the months of January 2022 and December 2023.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

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

  • Name: Alejandro Gonzalez-Ojeda, PhD
  • Phone Number: 52 33 312 941 65
  • Email: avygail5@gmail.com

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44329
        • Recruiting
        • Centro Médico Nacional de Occidente
        • Contact:
        • Contact:

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. First-time patients undergo surgical debridement of their burns.
  2. A burn percentage of 10-30% of burned body surface area
  3. Patients over 18 years of age
  4. Patients under 40
  5. IMSS beneficiaries

Exclusion Criteria:

  1. Burned patients with previous surgical debridement.
  2. Patients with co-morbids.
  3. Patients with a history of drug hypersensitivity.
  4. Patients with kidney disease.

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tranexamic acid
A total of 20 patients were included: 9 patients in the tranexamic acid group
Drug: Tranexamic acid
10mg/kg intravenous single dose
Placebo Comparator: placebo
A total of 20 patients were included: 11 patients in the control group using 0.9% isotonic saline solution.
Other: 0.9% isotonic saline solution
100 ml intravenous single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the group with tranexamic acid with the group with saline solution.
Time Frame: The time frame: the total time of the study is during the first day, only one dose will be given, and they will be compared at 24 hours.
The differences between the groups at the beginning of the study were evaluated with the Student's t test for continuous variables, and the proportions were compared with the Chi2 or Fisher test.
The time frame: the total time of the study is during the first day, only one dose will be given, and they will be compared at 24 hours.

Collaborators and Investigators

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

Sponsor

Instituto Mexicano del Seguro Social

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.

General Publications

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)

January 1, 2022

Primary Completion (Actual)

January 1, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tranexamic project

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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