Use of Tranexamic Acid in Liposculpture

NCT04430777 | Completed Phase 2 DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 141
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Blood Loss, Surgical

Keywords

Tranexamic Acid; Blood Loss; Liposculpture

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin

  All patients had hemoglobin tests taken prior to surgery, 24 hours postoperatively and 5 days postoperatively. We determine 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).

  Change from Baseline Hemoglobin at first posoperative and fifth posoperative day

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

No use of tranexamic acid. Subcutaneous infiltration of normal saline solution plus 1 mg of epinephrine as required for the procedure.

Drug: Tranexamic acid

Intravenous group

EXPERIMENTAL

A single dose of 1 gr of tranexamic acid (10 ml) IV, thirty minutes previous to the initiation of the surgery. Subcutaneous infiltration of normal saline solution plus 1 mg of epinephrine as required for the procedure.

Drug: Tranexamic acid

Subcutaneous group

EXPERIMENTAL

A single dose of 1 gr of tranexamic acid (10 ml) in the total of the infiltration mixture, as follow: 4 liters of infiltration contents 2.5 ml of tranexamic acid plus 1 mg epinephrine 5 liters of infiltration contents 2 ml of tranexamic acid plus 1 mg epinephrine. 6 liters of infiltration contents 1.6 ml of tranexamic acid plus 1 mg epinephrine.

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

Administration of tranexamic acid 1 gr either intravenously or subcutaneously

Intravenous group; Placebo group; Subcutaneous group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients that underwent liposculpture as unique procedure, surgical time between 2 and 5 hours, age between 20 and 45 years old and BMI between 20 and 30 m2/kg.

You may not qualify if:

• Patients that were operated of liposculpture and any additional procedure (Mammoplasty, tummy tuck, etc.), patients with history of thromboembolic disease or in Treatment with aspirin within 14 days before surgery or anticoagulants within 5 days prior to surgery, patients with history of epilepsy, patients with allergy to tranexamic acid, comorbidity grade III or IV according to ASA (American society of Anesthesiologists) and patients with prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) \>1.5 times the baseline.

Sponsors & Collaborators

• Total Definer Research Group: lead

Study Sites (3)

Dhara clinic

Bogotá, Colombia

Location

Innovare hospital

Jalisco, Mexico

Location

Centro Medico de las Americas clinic

Mérida, Mexico

Location

Related Publications (3)

• Ker K, Prieto-Merino D, Roberts I. Systematic review, meta-analysis and meta-regression of the effect of tranexamic acid on surgical blood loss. Br J Surg. 2013 Sep;100(10):1271-9. doi: 10.1002/bjs.9193. Epub 2013 Jul 9.

  PMID: 23839785 BACKGROUND

• Rohrich RJ, Cho MJ. The Role of Tranexamic Acid in Plastic Surgery: Review and Technical Considerations. Plast Reconstr Surg. 2018 Feb;141(2):507-515. doi: 10.1097/PRS.0000000000003926.

  PMID: 28938364 BACKGROUND

• Taam J, Yang QJ, Pang KS, Karanicolas P, Choi S, Wasowicz M, Jerath A. Current Evidence and Future Directions of Tranexamic Acid Use, Efficacy, and Dosing for Major Surgical Procedures. J Cardiothorac Vasc Anesth. 2020 Mar;34(3):782-790. doi: 10.1053/j.jvca.2019.06.042. Epub 2019 Jul 4.

  PMID: 31455576 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon, Head of Total Definer Research Group

Model Details: Patients were randomly assigned to three groups: Placebo group, intravenous group and subcutaneous group according to the administration route of tranexamic acid

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 12, 2020
• Study Start: January 17, 2019
• Primary Completion: February 22, 2020
• Study Completion: February 22, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1); ME (2)