Tranexamic Acid in Breast Esthetic Surgery.

Study Overview
=================
Brief Summary
-----------------
The investigators prepared a novel tranexamic acid (TXA) study designed to estimate the quantity of blood loss in patients undergoing breast esthetic surgery. This study aims to quantify blood loss during abdominoplasty with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in breast esthetic surgery patients.

Detailed Description
-----------------
Tranexamic acid (TXA) treatment is increasingly emphasized in plastic surgery because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prevention) and mitigating ongoing hemorrhage. TXA therapy has been principally studied in populations; the results of studies in plastic surgery still need to be improved. Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in various circumstances, primarily involving trauma patients. The investigators designed a randomized placebo-controlled trial comparing TXA dosing before incision for breast esthetic surgery. The purpose is to quantify blood loss during plastic surgery with and without TXA.

Official Title
-----------------
The Effectiveness of Tranexamic Acid in Breast Esthetic Surgery.

Conditions
-----------------
Hemorrhage, Bleeding

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Tranexamic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women scheduled for breast esthetic surgery ASA 1 or 2 age >18 and <75 years Exclusion Criteria: BMI <20 or >35 kg/m2 ASA 3 or > 3 medical history of thromboembolism history of hematological disease treatment with aspirin 14 days before the procedure treatment with anticoagulants 5 days before the procedure epilepsy allergy to tranexamic acid coagulation disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Normal saline for intravenous administration. | Drug: Placebo<br>* 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.<br>* Other names: 0.9% sodium chloride;|
| Active Comparator: Tranexamic acid<br>Tranexamic Acid for intravenous administration. | Drug: Tranexamic acid<br>* Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.<br>* Other names: TXA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss volume | Total blood volume loss will be calculated in milliliters. | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBG | Hemoglobin level measured before and 24 hours after surgery | 24 hours after surgery | 
| D-dimer | D-dimer level measured before and 24 hours after surgery | 24 hours after surgery | 
| Fibrinogen | Fibrinogen level measured before and 24 hours after surgery | 24 hours after surgery |