Tranexamic Acid Pharmacokinetics in Tumescent Solution: What Dose is Safe?
The overall aim of this study is to evaluate the efficacy of tranexamic acid (TXA) administered subcutaneously within tumescent fluid on blood loss, ecchymosis and seroma rates using a prospective, blinded, randomized control trial. Additionally, we will evaluate the pharmacokinetics of TXA using mass microscopy. The results of this study will provide preliminary definitive information on the efficacy of TXA reducing blood loss for liposuction procedures for plastic surgeons, and the safety profile of TXA when added to tumescent solution. These data, and knowledge obtained from our study, will contribute to advances in aesthetic plastic surgery, especially reduction in blood loss. The goal is to guide plastic surgeons in applying evidence-based medicine to their practices to prevent complications and improve outcomes.
The primary objective is to determine the efficacy of TXA in preventing postoperative ecchymosis, seroma, and intraoperative blood loss as well as the pharmacokinetics of TXA. We will investigate the amount of blood loss in liposuction infranatant fluid after infiltration with tumescent solution containing TXA compared to tumescent fluid without TXA. Lastly, we will objectively and subjectively assess postoperative bruising using artificial intelligence.
We hypothesize that the use of tumescent infiltration containing TXA into the subcutaneous tissue will reduce blood loss, bruising and seroma rates. We also hypothesize that a dose of 500 mg of TXA (1 cc/mL) added to 1L of tumescent solution will be a safe dose of TXA without added risk of toxicity.
Upon completion of the study, it is our expectation that we will be able to demonstrate the safety of TXA added to tumescent solution by its pharmacokinetic profile. We expect to show a significant decrease in intraoperative blood loss, postoperative ecchymosis, and seroma rates in the TXA study group compared to the standard tumescent liposuction control group.
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