Pharmacokinetic Study of Tranexamic Acid
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic acid Intravenous Infusion, TXA intramuscular injection.
- Who it may be relevant to
- Registry conditions: Ovarian Neoplasm Epithelial. Basic parameters: 20 years — 64 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacokinetic Study and Clinical Efficacy Observation of Different Routes of Tranexamic Acid Infusion in Advanced Ovarian Cancer Cell Reduction Surgery
Overview
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
- 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
Primary outcome measures
- Elimination clearance rate (CL) of tranexamic acid [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration]
Secondary outcome measures (2)
- Intraoperative blood loss [Time frame: during operative period]
- Blood transfusion volume [Time frame: during operative period]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hangzhou
Publications
- 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 bloo PMID 20554319
- 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 PMID 30413383
Identifiers
NCT: NCT06728670 · IRB-2024-1034