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Pharmacokinetic Study of Tranexamic Acid

Pharmacokinetic Study of Tranexamic Acid

Recruiting
20-64 years
Female
Phase N/A

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Overview

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.

Description

The investigators plan to recuit 30 patients, administered TXA through different routes of administration. Then Pharmacokinetic parameters of different TXA administration routes were recorded. To study the effects of different TXA administration routes on intraoperative blood loss, transfusion volume and postoperative adverse outcomes (thrombosis, etc.) in ovarian cancer patients undergoing cell reduction surgery.

Eligibility

Inclusion Criteria:

  1. Adult women aged 20-64 diagnosed with advanced ovarian cancer undergoing cytoreductive surgery
  2. The cancer stage is III-IV
  3. ASA classification II-III
  4. Surgical duration>2 hours

Exclusion Criteria:

  1. Renal dysfunction (serum creatinine>200 mmol/L) or liver dysfunction (Child Turcote classification>6)
  2. Has a history of serious mental illness or disorders, epilepsy, visual impairment
  3. Previous or current bleeding disorders, coagulation dysfunction, or thromboembolic events
  4. Lower limb venous thrombosis
  5. Anticoagulants or antifibrinolytic drugs used before surgery within the past month
  6. Allergic to TXA

Study details
    Ovarian Neoplasm Epithelial

NCT06728670

Zhejiang Cancer Hospital

21 October 2025

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