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Набор по приглашению NCT06618820

Extended Oral Tranexamic Acid After Total Knee Arthroplasty

Фаза III С лечением Osteo Arthritis Knee Pain, Postoperative

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, Placebo.
Кому может быть актуально
Состояния в реестре: Osteo Arthritis Knee, Pain, Postoperative. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
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

Randomized Control Trial for Oral Extended Tranexamic Acid After Total Knee Arthroplasty

Обзор

The utilization of intraoperative tranexamic acid (TXA), whether administered intravenously or orally, has become a standard practice in total joint arthroplasty (TJA). Multiple studies have demonstrated the positive impact that TXA application has on clinical outcomes, including decreased blood loss and transfusion rates, decreased early swelling and ecchymosis, improved early recovery, and potentially superior long-term outcomes. Its ability to mitigate risk of blood loss made ambulatory total knee arthroplasty (TKA) safer for patients. The safety of intraoperative TXA use has also been documented. Sabbag et al. showed that TXA does not increase the risk of venous thromboembolism (VTE), even in those patients who are deemed high-risk. Multiple routes of TXA administration have been studied with each route demonstrating effectiveness in reducing blood loss. Findings showed that oral TXA is noninferior to intravenous TXA, though the median time to reach a target concentration is longer via the oral route and bioavailability is lower. With the benefits of intraoperative TXA clearly documented in literature, multiple centers investigated the utilization of extended TXA postoperatively in hopes of enhancing patient safety and reducing length of stay and healthcare cost. However, these studies reported conflicting outcomes and mostly focused on estimated blood loss, instead of patient reported outcomes. The purpose of this study is to assess the effectiveness and safety of a varying extended oral TXA regimen during the postoperative period. Further, the investigators aim to determine the optimal duration of the TXA regimen to maximize its impact. The investigators hypothesize that an extended oral TXA regimen is safe and effective in improving clinical outcomes in TKA patients.

Вмешательства

  • Препарат Tranexamic acid
    One dose consists of three 650 milligram (mg) capsules, to be taken orally.
  • Препарат Placebo
    One dose consists of three microcrystalline cellulose capsules.

Первичные конечные точки

  • Forgotten Joint Score - Knee [Срок оценки: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.]
  • Range of Motion [Срок оценки: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.]
Вторичные конечные точки (6)
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement [Срок оценки: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.]
  • Patient-Reported Outcomes Measurement Information System [Срок оценки: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.]
  • Visual Analog Scale [Срок оценки: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.]
  • Opiate pill count [Срок оценки: postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.]
  • Ambulatory aid [Срок оценки: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.]
  • Adverse Event [Срок оценки: From signing consent form to completion of 1 year follow up visit.]

Критерии участия

Критерии включения

  • 18 years of age and older.
  • Primary TKA at a Campbell Clinic Surgery Center, with implant at the discretion of the treating surgeon.
  • Willing to participate in the study.
  • Fluent in oral and written English.

Критерии исключения

  • Revision TKA.
  • Preoperative use of anticoagulants (81mg aspirin is allowed).
  • Prior history of deep vein thrombosis.
  • Prior history of cancer (with the exception of non-melanoma/metastatic skin cancers, low-grade non-metastatic benign soft tissue tumors, thyroid cancers and low grade, non-metastatic prostate cancers).
  • Known allergy or hypersensitivity to TXA.
  • Patients who are using combination hormonal contraception.
  • History of seizure disorder.
  • History of adult onset colorblindness.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Campbell Clinic — Germantown

Идентификаторы

NCT: NCT06618820 · 24-10171-FB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗