NCT06728670

Pharmacokinetic Study of Tranexamic Acid

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Neoplasm Epithelial

Interventions

Type	Name	Description
BEHAVIORAL	Tranexamic acid Intravenous Infusion	A slow intravenous infusion of 1g TXA was administered at a rate of about 1ml/min.
BEHAVIORAL	TXA intramuscular injection	5ml intramuscular injections of TXA with twice, each injection time no more than 30 seconds, the injection site was selected as triangle

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-03-31
• Completion: 2025-08-31
• First posted: 2024-12-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: China