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Идёт набор NCT06728670

Pharmacokinetic Study of Tranexamic Acid

Без фазы С лечением Ovarian Neoplasm Epithelial

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Tranexamic acid Intravenous Infusion, TXA intramuscular injection.
Кому может быть актуально
Состояния в реестре: Ovarian Neoplasm Epithelial. Базовые параметры: 20 лет — 64 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Tranexamic acid Intravenous Infusion
    A slow intravenous infusion of 1g TXA was administered at a rate of about 1ml/min.
  • Поведенческое 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

Первичные конечные точки

  • Elimination clearance rate (CL) of tranexamic acid [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Before administration, 15minutes after administration, 45minutes after administration, 90minutes after administration, 3hours after administration, 6hours after administration and 24hours after administration]
Вторичные конечные точки (2)
  • Intraoperative blood loss [Срок оценки: during operative period]
  • Blood transfusion volume [Срок оценки: during operative period]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Zhejiang Cancer Hospital — Ханчжоу

Публикации

  • 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

Идентификаторы

NCT: NCT06728670 · IRB-2024-1034

Первоисточники (государственные реестры)

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