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Use of Tranexamic Acid in Liposculpture

NCT04430777 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2020-06-12

No results posted yet for this study

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

Interventions

DRUG

Tranexamic acid

Administration of tranexamic acid 1 gr either intravenously or subcutaneously

Sponsors & Collaborators

  • Total Definer Research Group

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2020-02-22
Completion
2020-02-22

Countries

  • Colombia
  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04430777 on ClinicalTrials.gov