Tranexamic Acid in Abdominoplasty.
The Effectiveness of Tranexamic Acid in Abdominoplasty Plastic Surgery.
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2023
CompletedFirst Posted
Study publicly available on registry
October 17, 2023
CompletedStudy Start
First participant enrolled
October 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2025
CompletedNovember 25, 2025
January 1, 2024
2 years
October 11, 2023
November 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Blood loss volume
Total blood volume loss will be calculated in milliliters.
24 hours after surgery
Secondary Outcomes (3)
HBG
24 hours after surgery
D-dimer
24 hours after surgery
Fibrinogen
24 hours after surgery
Study Arms (2)
Placebo
PLACEBO COMPARATORNormal saline for intravenous administration.
Tranexamic acid
ACTIVE COMPARATORTranexamic Acid for intravenous administration.
Interventions
100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.
Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.
Eligibility Criteria
You may qualify if:
- Scheduled abdominoplasty
- ASA 1 or 2
- age \>18 and \<75 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poznan University of Medical Sciences
Poznan, Poznań, 61-701, Poland
Related Publications (1)
Kolasinski J, Reysner T, Kolenda M, Kolacz S, Reysner M. Efficacy and safety of intravenous tranexamic acid in elective abdominoplasty: A randomized, triple-blinded, placebo-controlled clinical trial. J Plast Reconstr Aesthet Surg. 2025 Dec 5;113:693-699. doi: 10.1016/j.bjps.2025.11.055. Online ahead of print.
PMID: 41520615DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Małgorzata Domagalska, Ph.D.
Poznań University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2023
First Posted
October 17, 2023
Study Start
October 17, 2023
Primary Completion
October 10, 2025
Study Completion
October 10, 2025
Last Updated
November 25, 2025
Record last verified: 2024-01