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

Instituto Mexicano del Seguro Social

Status and phase: Enrolling; Phase 3

Conditions: Burns

Treatments: Drug: Tranexamic acid; Other: 0.9% isotonic saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05855590

Tranexamic project

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

tranexamic acid

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: 0.9% isotonic saline solution