Pharmacokinetic Study of Tranexamic Acid

University of Chinese Academy Sciences

Status: Enrolling

Conditions: Ovarian Neoplasm Epithelial

Treatments: Behavioral: TXA intramuscular injection; Behavioral: Tranexamic acid Intravenous Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06728670

IRB-2024-1034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Intravenous infusion of TXA

Active Comparator group

Description:

Slowly infuse 1g TXA at a rate of approximately 1 ml/min.

Treatment:

Behavioral: Tranexamic acid Intravenous Infusion

Intramuscular injection of TXA

Experimental group

Description:

1g TXA is administered with twice intramuscular injections, and each injection takes no more than 30 seconds. The injection site is chosen as the deltoid or lateral thigh muscle.

Treatment:

Behavioral: TXA intramuscular injection