Clinical trial NCT05855590: Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements
Official title: Efficacy of Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements at Centro Medico de Occidente'
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Burns
Keywords: burns
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2023-05-11
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare the group with tranexamic acid with the group with saline solution.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Médico Nacional de Occidente
state: Jalisco
Study officials:
References:
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.
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.
citation: 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.
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 16.