Clinical trial NCT06728670: Pharmacokinetic Study of Tranexamic Acid
Official title: Pharmacokinetic Study and Clinical Efficacy Observation of Different Routes of Tranexamic Acid Infusion in Advanced Ovarian Cancer Cell Reduction Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Neoplasm Epithelial
Keywords: Tranexamic acid
pharmacokinetics
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intravenous TXA injection group and intramuscular TXA injection group.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Elimination clearance rate (CL) of tranexamic acid
timeFrame: Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration
measure: Interventricular clearance rate (Q) of tranexamic acid
timeFrame: Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration
measure: Central ventricular volume (Vc) of tranexamic acid
timeFrame: Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration
measure: peripheral ventricular volume (Vp) of tranexamic acid
timeFrame: Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: during operative period
measure: Blood transfusion volume
timeFrame: during operative period
Other outcomes:
measure: New postoperative thrombotic complications
timeFrame: within 30 days after surgery.
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
citation: CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
citation: Vergote I, Coens C, Nankivell M, Kristensen GB, Parmar MKB, Ehlen T, Jayson GC, Johnson N, Swart AM, Verheijen R, McCluggage WG, Perren T, Panici PB, Kenter G, Casado A, Mendiola C, Stuart G, Reed NS, Kehoe S; EORTC; MRC CHORUS study investigators. Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials. Lancet Oncol. 2018 Dec;19(12):1680-1687. doi: 10.1016/S1470-2045(18)30566-7. Epub 2018 Nov 6.