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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05945680
Other study ID # 17/2023
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 15, 2023
Est. completion date December 1, 2024

Study information

Verified date July 2023
Source Poznan University of Medical Sciences
Contact Malgorzata Domagalska, Ph.D.
Phone +48 608762068
Email m.domagalska@icloud.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.
Tranexamic acid
Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.

Locations

Country Name City State
Poland Poznan University of Medical Sciences Poznan

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood loss volume Total blood volume loss will be calculated in milliliters. 24 hours after surgery
Secondary HBG Hemoglobin level measured before and 24 hours after surgery 24 hours after surgery
Secondary D-dimer D-dimer level measured before and 24 hours after surgery 24 hours after surgery
Secondary Fibrinogen Fibrinogen level measured before and 24 hours after surgery 24 hours after surgery
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