Tranexamic Acid in Abdominoplasty.

Poznan University of Medical Sciences (PUMS)

Status and phase: Enrolling; Phase 4

Conditions: Hemorrhage; Abdominal Wall Defect; Bleeding

Treatments: Drug: Tranexamic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06086444

16/2023

Details and patient eligibility

About

The investigators prepared a novel tranexamic acid (TXA) study designed to estimate the quantity of blood loss in patients undergoing abdominoplasty 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 patients undergoing abdominoplasty surgery.

Full 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 abdominoplasty. The purpose is to quantify blood loss during plastic surgery with and without TXA.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled abdominoplasty
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Normal saline for intravenous administration.

Treatment:

Drug: Placebo

Tranexamic acid

Active Comparator group

Description:

Tranexamic Acid for intravenous administration.

Treatment:

Drug: Tranexamic acid