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NCT Number: NCT06728670

Pharmacokinetic Study of Tranexamic Acid

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.

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Key information

Conditions

Ovarian Neoplasm Epithelial

Age range

20 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tranexamic acid Intravenous Infusion

Behavioral

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

TXA intramuscular injection

Behavioral

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

Primary outcomes

  1. Elimination clearance rate (CL) of tranexamic acid

    Time frame: Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration

    Patients were enrolled and screened during preoperative anaesthesia visit. The enrolled patients were randomly divided into IV TXA injection group and intramuscular TXA injection group. All blood samples were centrifuged and preserved for later testing,Nonlinear mixed-effects pharmacokinetic modeling was performed on the compartmental population pharmacokinetic data using the Monolix 2020R1 program.

  2. Interventricular clearance rate (Q) of tranexamic acid

    Time frame: Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration

    Patients were enrolled and screened during preoperative anaesthesia visit. The enrolled patients were randomly divided into IV TXA injection group and intramuscular TXA injection group. All blood samples were centrifuged and preserved for later testing,Nonlinear mixed-effects pharmacokinetic modeling was performed on the compartmental population pharmacokinetic data using the Monolix 2020R1 program.

  3. Central ventricular volume (Vc) of tranexamic acid

    Time frame: Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration

    Patients were enrolled and screened during preoperative anaesthesia visit. The enrolled patients were randomly divided into IV TXA injection group and intramuscular TXA injection group. All blood samples were centrifuged and preserved for later testing,Nonlinear mixed-effects pharmacokinetic modeling was performed on the compartmental population pharmacokinetic data using the Monolix 2020R1 program.

  4. peripheral ventricular volume (Vp) of tranexamic acid

    Time frame: Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration

    Patients were enrolled and screened during preoperative anaesthesia visit. The enrolled patients were randomly divided into IV TXA injection group and intramuscular TXA injection group. All blood samples were centrifuged and preserved for later testing,Nonlinear mixed-effects pharmacokinetic modeling was performed on the compartmental population pharmacokinetic data using the Monolix 2020R1 program.

Secondary outcomes

  1. Intraoperative blood loss

    Time frame: during operative period

    blood should be taken before surgery for Hb or Hct measurements to determine the patient's current blood dilution or concentration.The calculation formula: estimated blood loss (ml) = (preoperative or estimated Hct - measured Hct) / preoperative or estimated Hctx weight (kg) x 7% x 1000.

  2. Blood transfusion volume

    Time frame: during operative period

    The total volume of blood transfused during the operation was calculated, encompassing red blood cells, plasma, and cryoprecipitate.

Other outcomes

  1. New postoperative thrombotic complications

    Time frame: within 30 days after surgery.

    ncidence of complications (new thrombus) are detected by vascular ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Yejing Zhu, PHD

CONTACT

[email protected]

86+18758096745

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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