Use of Tranexamic Acid in Liposculpture

• Status: Completed
• Trial end date: 2020-02-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Total Definer Research Group
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.