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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Normal saline for intravenous administration. |
|
| Tranexamic acid | Active Comparator | Tranexamic Acid for intravenous administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss volume | Total blood volume loss will be calculated in milliliters. | 24 hours after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
adult women
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| Name | Affiliation | Role |
|---|---|---|
| Małgorzata Domagalska, Ph.D. | Poznań University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Poznan | Poland |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Tranexamic acid | Drug | Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision. |
|
|
| 24 hours after surgery |
| Fibrinogen | Fibrinogen level measured before and 24 hours after surgery | 24 hours after surgery |
| D017670 |
| Sodium Compounds |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |