Efficacy and safety of intravenous tranexamic acid in elective abdominoplasty: A randomized, triple-blinded, placebo-controlled clinical trial.
Abstract
[BACKGROUND] Tranexamic acid (TXA) is increasingly used in esthetic plastic surgery to minimize perioperative bleeding and postoperative bruising. However, its benefit in abdominoplasty-a procedure with typically low blood loss-remains unclear.
[OBJECTIVES] To assess the efficacy and safety of a single preoperative intravenous dose of TXA in reducing total intraoperative plus postoperative (first 24 h) blood loss and influencing coagulation activity during elective abdominoplasty.
[METHODS] In this randomized, triple-blinded, placebo-controlled trial (NCT06086444), 60 ASA I-II patients undergoing abdominoplasty received either TXA (10 mg/kg IV) or placebo 10 min before incision. The primary outcome was total blood loss within 24 h (suction, swab, and drain). Secondary outcomes included perioperative changes in D-dimer and fibrinogen concentrations, as well as adverse events. Analyses followed the intention-to-treat principle.
[RESULTS] All 60 participants completed the study. Mean intraoperative blood loss was 130.1 ± 57.7 mL with TXA vs. 127.3 ± 64.9 mL with placebo (p = 0.886). Mean 24-h drain output was 224.1 ± 114.1 mL vs. 179.2 ± 74.7 mL (p = 0.137). D-dimer and fibrinogen levels showed no significant perioperative changes (all p > 0.05). No thromboembolic, allergic, or neurological events occurred. Total blood loss remained below 400 mL in all cases, and no transfusions were required.
[CONCLUSIONS] A single preoperative 10 mg/kg IV dose of TXA did not significantly reduce perioperative blood loss or affect coagulation parameters in abdominoplasty. TXA was safe and well tolerated, supporting its selective rather than routine use, particularly in high-risk or combined procedures.
[GOV IDENTIFIER] NCT06086444.
[LEVEL OF EVIDENCE] I (Therapeutic).
[OBJECTIVES] To assess the efficacy and safety of a single preoperative intravenous dose of TXA in reducing total intraoperative plus postoperative (first 24 h) blood loss and influencing coagulation activity during elective abdominoplasty.
[METHODS] In this randomized, triple-blinded, placebo-controlled trial (NCT06086444), 60 ASA I-II patients undergoing abdominoplasty received either TXA (10 mg/kg IV) or placebo 10 min before incision. The primary outcome was total blood loss within 24 h (suction, swab, and drain). Secondary outcomes included perioperative changes in D-dimer and fibrinogen concentrations, as well as adverse events. Analyses followed the intention-to-treat principle.
[RESULTS] All 60 participants completed the study. Mean intraoperative blood loss was 130.1 ± 57.7 mL with TXA vs. 127.3 ± 64.9 mL with placebo (p = 0.886). Mean 24-h drain output was 224.1 ± 114.1 mL vs. 179.2 ± 74.7 mL (p = 0.137). D-dimer and fibrinogen levels showed no significant perioperative changes (all p > 0.05). No thromboembolic, allergic, or neurological events occurred. Total blood loss remained below 400 mL in all cases, and no transfusions were required.
[CONCLUSIONS] A single preoperative 10 mg/kg IV dose of TXA did not significantly reduce perioperative blood loss or affect coagulation parameters in abdominoplasty. TXA was safe and well tolerated, supporting its selective rather than routine use, particularly in high-risk or combined procedures.
[GOV IDENTIFIER] NCT06086444.
[LEVEL OF EVIDENCE] I (Therapeutic).
추출된 의학 개체 (NER)
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 약물 | txa
|
트라넥삼산 | dict | 6 | |
| 시술 | abdominoplasty
|
복부성형술 | dict | 5 | |
| 약물 | tranexamic acid
|
트라넥삼산 | dict | 2 | |
| 해부 | blood loss-remains
|
scispacy | 1 | ||
| 해부 | intravenous
|
scispacy | 1 | ||
| 해부 | blood
|
scispacy | 1 | ||
| 약물 | NCT06086444
|
scispacy | 1 | ||
| 약물 | intravenous tranexamic acid
|
scispacy | 1 | ||
| 약물 | [BACKGROUND] Tranexamic acid
|
scispacy | 1 | ||
| 약물 | [OBJECTIVES]
|
scispacy | 1 | ||
| 약물 | [CONCLUSIONS] A
|
scispacy | 1 | ||
| 질환 | bleeding
|
C0019080
Hemorrhage
|
scispacy | 1 | |
| 질환 | bruising
|
C0009938
Contusions
|
scispacy | 1 | |
| 질환 | blood loss
|
C0019080
Hemorrhage
|
scispacy | 1 | |
| 질환 | thromboembolic
|
C0333214
thromboembolic
|
scispacy | 1 | |
| 질환 | allergic
|
C0700624
Allergic
|
scispacy | 1 | |
| 기타 | patients
|
scispacy | 1 | ||
| 기타 | D-dimer
|
scispacy | 1 | ||
| 기타 | fibrinogen
|
scispacy | 1 | ||
| 기타 | transfusions
|
scispacy | 1 |
MeSH Terms
Humans; Tranexamic Acid; Abdominoplasty; Female; Antifibrinolytic Agents; Male; Blood Loss, Surgical; Middle Aged; Adult; Elective Surgical Procedures; Treatment Outcome; Fibrin Fibrinogen Degradation Products; Double-Blind Method; Fibrinogen; Administration, Intravenous; Postoperative Hemorrhage
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