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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855590
• Other study ID #: Tranexamic project
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Instituto Mexicano del Seguro Social
• Contact: Alejandro Gonzalez-Ojeda, PhD
• Phone: 33 312 941 65
• Email: avygail5[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Tranexamic acid
10mg/kg intravenous single dose

Other:
• 0.9% isotonic saline solution
100 ml intravenous single dose

Locations

Country	Name	City	State
Mexico	Centro Médico Nacional de Occidente	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.