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RecruitingNCT05855590Updated May 11, 2023

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

A Phase 3 interventional study of Tranexamic acid and 0.9% isotonic saline solution in Burns, sponsored by Instituto Mexicano del Seguro Social. Recruiting at 1 site in Mexico. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by Instituto Mexicano del Seguro Social · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2022, registered Mar 2023).
  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Burns

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Keywords

  • burns
03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 524 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Instituto Mexicano del Seguro Social is the lead sponsor of 124 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    tranexamic acid

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

    Drug: Tranexamic acid

  • 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

Interventions

  • DrugTranexamic acid

    10mg/kg intravenous single dose

  • Other0.9% isotonic saline solution

    100 ml intravenous single dose

06

What researchers measure

Primary outcomes

  1. 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.

    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.

07

Study locations

1 of 1 sites recruiting
  • Centro Médico Nacional de Occidente
    Guadalajara, Jalisco 44329, Mexico
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27827518 ↗
  • 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. PubMed 34952736 ↗
  • 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. PubMed 34740174 ↗
  • 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. PubMed 35339324 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05855590
Lead sponsor
Instituto Mexicano del Seguro Social
Responsible party
GONZALEZ-OJEDA ALEJANDRO (Investigator, Instituto Mexicano del Seguro Social) — Principal investigator
First posted
May 11, 2023
Start date
Jan 1, 2022
Primary completion
Jan 1, 2022
Completion
Dec 30, 2023 (estimated)
Last update
May 11, 2023

Study contacts

Alejandro Gonzalez-Ojeda, PhD
Contact
avygail5@gmail.com
33 312 941 65 ext. 52

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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