Use of Tranexamic Acid in Liposculpture
Condition: Blood Loss, Surgical
MeSH terms: Hemorrhage; Blood Loss, Surgical
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Blood loss during a surgical procedure is inevitable, its reduction is a key factor for
      surgical success. Also, to avoid progress to severe complications like hemodynamic
      decompensation, cardiac arrest or the need to blood transfusions. According to the Center for
      Disease Control (CDC), there is a usage of more than 17 million transfused blood products
      units per year. Blood transfusion is a convenient technique for reposition of blood during
      major bleed, but it involves several probable complications like anaphylaxis, bloodborne
      infections and others. Consequently, meticulous hemostasis during surgery is crucial to
      diminish blood loss.

      Hemostatic agents play a pivotal role during surgical time. Amongst them topical,
      energy-based and systemic agents are the vast majority. Tranexamic acid (TXA) is a lysine
      synthetic derivate that inhibits fibrinolysis by blocking the 5 lysine-binding sites to
      plasminogen. It has been used in clinical practice since 1962 and become very popular after
      2010 when the CRASH-2 study showed a decreased risk of death in trauma patients.

      Tranexamic acid use is widely extended among diverse surgical fields: orthopedics, cardiac
      surgery and obstetrics. In plastic surgery it uses is limited mainly to craniofacial surgery
      as a local agent. The aim of this trial is to show the efficacy of tranexamic acid as
      hemostatic agent in liposuction and to compare its efficacy among different administration
      routes.
    

Detailed description: 
      In 3 plastic surgery centers, the investigators randomized patients in a double-blind,
      randomized, controlled trial comparing the clinical outcomes of different administration
      routes of TXA, intravenous versus subcutaneous versus placebo between January 2019 to
      February 2020. The study was approved by the Ethics committee at the central coordinating
      center and at each of the participating sites. The centers of the study were, Dhara clinic,
      Bogota, Colombia, Centro Medico de las Americas clinic, in Mérida, Mexico and Innovare
      hospital in Jalisco, Mexico. Once a month, the investigators performed only meetings between
      the researcher coordinator and delegates from each of the centers to audit the data
      collection and information registration.

      During the preoperative consultation, the study interventions were explained clearly to each
      participants. Participants were given adequate time to ponder the information, had any
      questions answered and gave their free and voluntary consent. A total of 141 participants
      were recollected. The primary outcome was the difference regarding to hemoglobin loss points
      between groups. All patients had hemoglobin and hematocrit tests taken prior to surgery, 24
      hours postoperatively and 5 days postoperatively. The investigators determined the hemoglobin
      loss points in each group by deduct the postoperative hemoglobin at day one to the
      preoperative hemoglobin (For hemoglobin loss at day 1) and the postoperative hemoglobin at
      day five to the preoperative hemoglobin (For hemoglobin loss at day 5). As a secondary
      outcome, the investigators performed a subgroup analysis to determine the difference in
      hematological parameters (hemoglobin and hematocrit) between the groups.

      Sample size and Statistical Analysis Sample size was calculated using the online app from
      sealed envelope where 96 patients were required to have a 90% of chance of detecting, as
      significant at the 5% level, a difference between the mean postoperative Hb value from 10.5
      g/dl in the control group to 11.5 g/dl in the experimental group and an estimated standard
      deviation (SD) of 1.5 g/dl. Since, the investigators planned two experimental approaches:
      Subcutaneous (SC) TA and Intravenous (IV) TA; 141 patients were randomized into 3 groups: 1.
      IV-TA group (n=47), 2. SC-TA group (n=47) and NS group. Demographic and clinical
      characteristics were described, hematological parameters were analyzed per group before
      surgery, at the immediate post-operative period, and at the fifth post-operative day. The
      descriptive analysis was made through means and medians according to the distribution of
      variables.

      For categorical variables, counts and percentages were used. The quantitative variables with
      parametric distribution were compared using ANOVA, and for variables with non-parametric
      distribution using Kruskal-Wallis test, while the frequencies of the qualitative variables
      were compared using Chi2 test. We used a boxplot to illustrate the differences between the
      means of the hemoglobin by group. Bilateral hypotheses were formulated at two tails with
      significance level less than 0.05. The data were collected in Microsoft excel and the
      statistical analysis were performed in the statistical program STATA version 15.0.
    

Intervention name(s): Tranexamic acid
Intervention type(s): Drug
Intervention description(s): Administration of tranexamic acid 1 gr either intravenously or subcutaneously
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomly assigned to three groups: Placebo group, intravenous group and subcutaneous group according to the administration route of tranexamic acid
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tranexamic Acid; Blood Loss; Liposculpture