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

Phase 3

Recruiting

• Conditions: Burns
• Interventions: Other: 0.9% isotonic saline solution; Drug: Tranexamic acid

• Registration Number: NCT05855590
• Lead Sponsor: Instituto Mexicano del Seguro Social

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-01-01
• Study First Submitted: 2023-03-30
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-03
• Last Update Submitted: 2023-05-03
• Study First Posted: 2023-05-11
• Last Update Posted: 2023-05-11
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
placebo	0.9% isotonic saline solution	A total of 20 patients were included: 11 patients in the control group using 0.9% isotonic saline solution.
tranexamic acid	Tranexamic acid	A total of 20 patients were included: 9 patients in the tranexamic acid group

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Centro Médico Nacional de Occidente; 🇲🇽 Guadalajara, Jalisco, Mexico