Pharmacokinetic Study of Tranexamic Acid

NCT06728670 | Recruiting DMC

• 1 other identifier: IRB-2024-1034
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasm Epithelial

Keywords

Tranexamic acid; pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• 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.

  Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration

• 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.

  Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration

• 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.

  Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration

• 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.

  Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration

Secondary Outcomes (2)

• Intraoperative blood loss

  during operative period

• Blood transfusion volume

  during operative period

Other Outcomes (1)

• New postoperative thrombotic complications

  within 30 days after surgery.

Study Arms (2)

Intravenous infusion of TXA

ACTIVE COMPARATOR

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

Behavioral: Tranexamic acid Intravenous Infusion

Intramuscular injection of TXA

EXPERIMENTAL

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.

Behavioral: TXA intramuscular injection

Interventions

Tranexamic acid Intravenous Infusion BEHAVIORAL

A slow intravenous infusion of 1g TXA was administered at a rate of about 1ml/min.

Intravenous infusion of TXA

TXA intramuscular injection BEHAVIORAL

5ml intramuscular injections of TXA with twice, each injection time no more than 30 seconds, the injection site was selected as triangle

Intramuscular injection of TXA

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Anticoagulants or antifibrinolytic drugs used before surgery within the past month
• Allergic to TXA

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 20554319 RESULT

• 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.

  PMID: 30413383 RESULT

Central Study Contacts

Yejing Zhu, PHD

CONTACT

86+18758096745; zhuyejing1983@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Intravenous TXA injection group and intramuscular TXA injection group.

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: December 11, 2024
• Study Start: November 20, 2024
• Primary Completion: March 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)