Pharmacokinetic Study of Tranexamic Acid
ConditionOvarian Neoplasm Epithelial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-64
SponsorZhejiang Cancer Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic acid Intravenous Infusion
BehavioralA slow intravenous infusion of 1g TXA was administered at a rate of about 1ml/min.
TXA intramuscular injection
Behavioral5ml intramuscular injections of TXA with twice, each injection time no more than 30 seconds, the injection site was selected as triangle
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Intravenous infusion of TXAActive comparator 1 intervention
Group B: Intramuscular injection of TXAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Elimination clearance rate (CL) of tranexamic acid
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.
Time frame
Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration2
Interventricular clearance rate (Q) of tranexamic acid
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.
Time frame
Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration3
Central ventricular volume (Vc) of tranexamic acid
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.
Time frame
Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration4
peripheral ventricular volume (Vp) of tranexamic acid
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.
Time frame
Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administrationSecondary outcomes
1
Intraoperative blood loss
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.
Time frame
during operative period2
Blood transfusion volume
The total volume of blood transfused during the operation was calculated, encompassing red blood cells, plasma, and cryoprecipitate.
Time frame
during operative periodOther outcomes
1
New postoperative thrombotic complications
ncidence of complications (new thrombus) are detected by vascular ultrasound
Time frame
within 30 days after surgery.Sponsors and contacts
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Source ClinicalTrials.gov