RecruitingNot ApplicableNCT06728670

Pharmacokinetic Study of Tranexamic Acid

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

Sponsor

Zhejiang Cancer Hospital

Enrollment

30 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Ovarian Neoplasm Epithelial

Summary

Tranexamic acid is an effective anti fibrinolytic drug. Clinical studies have found that intravenous injection of tranexamic acid is more effective in reducing blood loss and transfusion in patients with advanced ovarian cancer, without increasing the risk of postoperative complications. Different surgeries and administration routes have an impact on the pharmacokinetics and pharmacodynamics of TXA. At present, there is little data on the pharmacokinetics of intramuscular injection of TXA, and almost all of the data comes from males. For ovarian cancer patients, there are currently no reports on the pharmacokinetics of TXA through different routes of administration, such as intramuscular and intravenous administration. Therefore, the investigators chose ovarian cancer patients and administered it through different routes of intravenous and intramuscular injection.

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how a medication called tranexamic acid (used to reduce bleeding during surgery) behaves in the body during major ovarian cancer surgery. Understanding its pharmacokinetics (how the drug is absorbed and cleared) will help doctors use it more effectively. **You may be eligible if...** - You are a woman between 20 and 64 years old - You have advanced (stage III-IV) ovarian cancer and are having cytoreductive (tumor-removal) surgery - Your surgery is expected to last more than 2 hours - Your overall anesthesia risk is classified as ASA II-III **You may NOT be eligible if...** - You have kidney or liver problems beyond certain thresholds - You have a history of serious mental illness, epilepsy, or significant vision problems - You have a bleeding disorder, clotting problem, or history of blood clots - You have deep vein thrombosis (blood clots in the leg) - You took blood thinners or anti-clotting medications within the past month - You are allergic to tranexamic acid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTranexamic acid Intravenous Infusion

A slow intravenous infusion of 1g TXA was administered at a rate of about 1ml/min.

BEHAVIORALTXA intramuscular injection

5ml intramuscular injections of TXA with twice, each injection time no more than 30 seconds, the injection site was selected as triangle

Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06728670

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