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

NCT05855590 | Unknown Phase 3

• 1 other identifier: Tranexamic project
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Burns

Keywords

burns

Outcome Measures

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.

  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.

Study Arms (2)

tranexamic acid

EXPERIMENTAL

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

Drug: Tranexamic acid

placebo

PLACEBO COMPARATOR

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

Tranexamic acid DRUG

10mg/kg intravenous single dose

tranexamic acid

0.9% isotonic saline solution OTHER

100 ml intravenous single dose

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• First-time patients undergo surgical debridement of their burns.
• A burn percentage of 10-30% of burned body surface area
• Patients over 18 years of age
• Patients under 40
• IMSS beneficiaries

You may not qualify if:

• Burned patients with previous surgical debridement.
• Patients with co-morbids.
• Patients with a history of drug hypersensitivity.
• Patients with kidney disease.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Centro Médico Nacional de Occidente

Guadalajara, Jalisco, 44329, Mexico

RECRUITING

Related Publications (4)

• 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.

  PMID: 27827518 BACKGROUND

• 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.

  PMID: 34952736 BACKGROUND

• 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.

  PMID: 34740174 BACKGROUND

• 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.

  PMID: 35339324 RESULT

MeSH Terms

Conditions

Burns

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Alejandro Gonzalez-Ojeda, PhD

CONTACT

33 312 941 65; avygail5@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 11, 2023
• Study Start: January 1, 2022
• Primary Completion: January 1, 2022
• Study Completion: December 30, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)