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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05855590

Enrollment

Registered

2023-05-11

Start date

2022-01-01

Completion date

2023-12-30

Last updated

2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

burns

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.

Interventions

DRUGTranexamic acid

10mg/kg intravenous single dose

OTHER0.9% isotonic saline solution

100 ml intravenous single dose

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention 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.

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Compare the group with tranexamic acid with the group with saline solution.	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.

Countries

Mexico

Contacts

Primary ContactAlejandro Gonzalez-Ojeda, PhD

avygail5@gmail.com33 312 941 65

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026