Bleeding, Hemorrhage
Conditions
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.
Interventions
DRUGPlacebo
100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.
DRUGTranexamic acid
Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss volume | 24 hours after surgery | Total blood volume loss will be calculated in milliliters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fibrinogen | 24 hours after surgery | Fibrinogen level measured before and 24 hours after surgery |
| HBG | 24 hours after surgery | Hemoglobin level measured before and 24 hours after surgery |
| D-dimer | 24 hours after surgery | D-dimer level measured before and 24 hours after surgery |
Countries
Poland
Outcome results
None listed