Ovarian Neoplasm Epithelial
Conditions
Keywords
Tranexamic acid, pharmacokinetics
Brief 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.
Detailed 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.
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
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Intravenous TXA injection group and intramuscular TXA injection group.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elimination clearance rate (CL) of tranexamic acid | 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. |
| Interventricular clearance rate (Q) of tranexamic acid | 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. |
| Central ventricular volume (Vc) of tranexamic acid | 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. |
| peripheral ventricular volume (Vp) of tranexamic acid | 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
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | 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. |
| Blood transfusion volume | during operative period | The total volume of blood transfused during the operation was calculated, encompassing red blood cells, plasma, and cryoprecipitate. |
Other
| Measure | Time frame | Description |
|---|---|---|
| New postoperative thrombotic complications | within 30 days after surgery. | ncidence of complications (new thrombus) are detected by vascular ultrasound |
Countries
China
Contacts
Primary ContactYejing Zhu, PHD
Outcome results
None listed