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

• Sponsor: Instituto Mexicano del Seguro Social (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05855590
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Burns	Drug: Tranexamic acid; Other: 0.9% isotonic saline solution	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• 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.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.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements at Centro Medico de Occidente'
• Actual Study Start Date: Jan 1, 2022
• Actual Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tranexamic acid A total of 20 patients were included: 9 patients in the tranexamic acid group	Drug: Tranexamic acid; 10mg/kg intravenous single dose
Placebo Comparator: placebo 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; 100 ml intravenous single dose

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Médico Nacional de Occidente	Guadalajara	Jalisco	Mexico	44329

Sponsors and Collaborators

• Instituto Mexicano del Seguro Social

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: GONZALEZ-OJEDA ALEJANDRO, Investigator, Instituto Mexicano del Seguro Social
• ClinicalTrials.gov Identifier: NCT05855590
• Other Study ID Numbers: Tranexamic project
• First Posted: May 11, 2023
• Last Update Posted: May 11, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by GONZALEZ-OJEDA ALEJANDRO, Investigator, Instituto Mexicano del Seguro Social: burns
• Additional relevant MeSH terms: Burns; Tranexamic Acid

Study Results

No Results Posted as of May 11, 2023