Pharmacokinetic Study and Clinical Efficacy Observation of Different Routes of Tranexamic Acid Infusion in Advanced Ovarian Cancer Cell Reduction Surgery

What this Trial Is About

Researchers are studying the effects of tranexamic acid, an antifibrinolytic drug, in women with advanced ovarian cancer undergoing cytoreductive surgery. This study focuses on comparing the pharmacokinetics of tranexamic acid when given by intravenous infusion versus intramuscular injection. Since most existing data on intramuscular administration comes from males, this research aims to better understand how different administration routes affect drug behavior and surgical outcomes in women with ovarian cancer. Participants will receive tranexamic acid either through a slow intravenous infusion of 1 gram at about 1 ml per minute or through two intramuscular injections of 1 gram total, administered in the deltoid or lateral thigh muscles. The study involves randomly assigning patients to one of these two treatment groups to compare the drug's clearance rates, volume distribution, and impact on blood loss and transfusion during surgery. During the study, researchers will monitor pharmacokinetic parameters of tranexamic acid at multiple time points before and after administration, including 15 minutes, 45 minutes, 90 minutes, 3 hours, 6 hours, and 24 hours. They will also record intraoperative blood loss and transfusion volume, as well as observe for postoperative complications like thrombosis. The study is planned to enroll 30 women aged 20 to 64 and includes clinical assessments throughout the surgery and postoperative period to evaluate safety and drug effects.

Pharmacokinetic Study of Tranexamic Acid