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

Primary Purpose

Burns

Status
Recruiting
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Tranexamic acid
0.9% isotonic saline solution
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring burns

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: First-time patients undergo surgical debridement of their burns. A burn percentage of 10-30% of burned body surface area Patients over 18 years of age Patients under 40 IMSS beneficiaries Exclusion Criteria: Burned patients with previous surgical debridement. Patients with co-morbids. Patients with a history of drug hypersensitivity. Patients with kidney disease.

Sites / Locations

  • Centro Médico Nacional de OccidenteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tranexamic acid

placebo

Arm Description

A total of 20 patients were included: 9 patients in the tranexamic acid group

A total of 20 patients were included: 11 patients in the control group using 0.9% isotonic saline solution.

Outcomes

Primary Outcome Measures

Compare the group with tranexamic acid with the group with saline solution.
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.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2023
Last Updated
May 3, 2023
Sponsor
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT05855590
Brief Title
Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements
Official Title
Efficacy of Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements at Centro Medico de Occidente'
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social

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
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Model Description
Randomized, double-blind, prospective trial to establish the effect of intraoperative tranexamic acid in early surgical debridement of severe burns. The study was carried out between the months of January 2022 to December 2022.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tranexamic acid
Arm Type
Experimental
Arm Description
A total of 20 patients were included: 9 patients in the tranexamic acid group
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
A total of 20 patients were included: 11 patients in the control group using 0.9% isotonic saline solution.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
10mg/kg intravenous single dose
Intervention Type
Other
Intervention Name(s)
0.9% isotonic saline solution
Intervention Description
100 ml intravenous single dose
Primary Outcome Measure Information:
Title
Compare the group with tranexamic acid with the group with saline solution.
Description
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.
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First-time patients undergo surgical debridement of their burns. A burn percentage of 10-30% of burned body surface area Patients over 18 years of age Patients under 40 IMSS beneficiaries Exclusion Criteria: Burned patients with previous surgical debridement. Patients with co-morbids. Patients with a history of drug hypersensitivity. Patients with kidney disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Gonzalez-Ojeda, PhD
Phone
33 312 941 65
Ext
52
Email
avygail5@gmail.com
Facility Information:
Facility Name
Centro Médico Nacional de Occidente
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44329
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro González Ojeda, PhD
Phone
3336683000
Email
avygail5@gmail.com
First Name & Middle Initial & Last Name & Degree
Gonzalo Delgado-Hernandez
Phone
3321822949
Email
medicinagon@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27827518
Citation
Dominguez A, Alsina E, Landin L, Garcia-Miguel JF, Casado C, Gilsanz F. Transfusion requirements in burn patients undergoing primary wound excision: effect of tranexamic acid. Minerva Anestesiol. 2017 Apr;83(4):353-360. doi: 10.23736/S0375-9393.16.10992-7. Epub 2016 Nov 9.
Results Reference
background
PubMed Identifier
34952736
Citation
K S A, Kumar P, Subair M, Sharma RK. Effect of single dose intravenous tranexamic acid on blood loss in tangential excision of burn wounds - A double blind randomised controlled trial. Burns. 2022 Sep;48(6):1311-1318. doi: 10.1016/j.burns.2021.08.021. Epub 2021 Aug 30.
Results Reference
background
PubMed Identifier
34740174
Citation
Brown NJ, Choi EH, Gendreau JL, Ong V, Himstead A, Lien BV, Shahrestani S, Ransom SC, Tran K, Tafreshi AR, Sahyouni R, Chan A, Oh MY. Association of tranexamic acid with decreased blood loss in patients undergoing laminectomy and fusion with posterior instrumentation: a systematic review and meta-analysis. J Neurosurg Spine. 2021 Nov 5;36(4):686-693. doi: 10.3171/2021.7.SPINE202217. Print 2022 Apr 1.
Results Reference
background
PubMed Identifier
35339324
Citation
Tapking C, Hundeshagen G, Kirchner M, Fischer S, Kneser U, Bliesener B. Tranexamic acid reduced blood transfusions in acute burn surgery: A retrospective case-controlled trial. Burns. 2022 May;48(3):522-528. doi: 10.1016/j.burns.2022.03.002. Epub 2022 Mar 16.
Results Reference
result

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

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