Serial Use of Intravenous and Oral Tranexamic Acid in Primary Total Knee Arthroplasty Patients
Serial Use of Intravenous and Oral Tranexamic Acid in Primary Total Knee Arthroplasty Patients: A Randomized Controlled Study
Обзор исследования
Подробное описание
It has been demonstrated that tranexamic acid (TXA) reduces the peri-operative blood loss as well as the need for transfusion in total knee replacement arthroplasty(TKRA). The anti-fibrinolytic effects of TXA have been shown to mainly present in the wound that, in previous studies, the use of TXA decreased the blood loss without increasing the risk of thromboembolic complications. Nevertheless, the optimal dose, duration of treatment and route of administration of TXA to reduce blood loss while minimizing adverse effects remain uncertain.
To use TXA as a pharmacologic alternative to transfusion, optimal regimen should be elucidated. Various studies have reported the effect of perioperative use of intravenous or topical TXA. Meta-analyses concluded that combined use of intravenous and topical TXA is more effective in reducing the blood loss and transfusion rate without increasing the risk of deep vein thrombosis or pulmonary embolism compared to the use of either intravenous TXA or topical TXA alone. Both intravenous and topical administration was conducted pre or intraoperatively or within 6 hours post-operatively mainly due to conceivable risk of thromboembolic event when TXA is used continuously after surgery. However, regarding the fact that systemic activation of fibrinolysis starts post-operatively in TKRA using tourniquets and lasts over 18 hours, the continuous use of TXA after surgery might have additional benefit over the single day use. Moreover, the serial use of post-operative oral TXA for 5 days after perioperative IV TXA use has been shown to significantly reduce transfusion rate without increasing thromboembolic complications compared to placebo.
Therefore, in this study, the investigators aimed to 1) investigate the effect of serial use of perioperative IV and post-operative oral TXA in reducing the blood loss and transfusion risk compared to single day perioperative use of IV TXA and 2) assess the sufficient length of postoperative use of oral TXA in TKRA patients.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
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Dongjak Gu
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Seoul, Dongjak Gu, Корея, Республика, 07061
- Рекрутинг
- Seoul National University Boramae Medical Center
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Контакт:
- Seung-Baik Kang, MD, PhD
- Номер телефона: +82-2-870-3931
- Электронная почта: ossbkang@gmail.com
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Контакт:
- Chan Yoon, MD
- Номер телефона: +82-2-870-2316
- Электронная почта: yoon.chan.alex@gmail.com
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Главный следователь:
- Seung-Baik Kang, MD, PhD
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Главный следователь:
- Chong Bum Chang, MD, PhD
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Главный следователь:
- Moon Jong Chang, MD, PhD
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Главный следователь:
- Chan Yoon, MD
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Главный следователь:
- Min Kyu Song, MD
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Главный следователь:
- Jae-Hoon Shin, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Candidate for total knee replacement arthroplasty due to osteoarthritis of the knee.
Exclusion Criteria:
- Known allergic reaction to tranexamic acid
- Secondary arthritis (ex. Rheumatic arthritis, traumatic arthritis, septic arthritis)
- History of thromboembolic event including deep vein thrombosis, pulmonary embolism, cerebral infarction, transient ischemic attack, myocardial infarction, angina
- Premenopausal female
- Known congenital or acquired coagulopathy
- Currently in treatment with Adenosine disphosphate receptor inhibitors, Vitamin K antagonist, Factor Xa inhibitor, Direct thrombin inhibitor or Heparin
- Aspirin administration within 5 days before operation
- Preoperative Prothrombin time(PT) international normalized ratio(INR) > 1.4
- Severe systemic comorbidities of American Society of Anesthesiology (ASA) grade 4 including heart failure, renal failure, hepatic failure, pulmonary disease and cancer
- Do not agree to participate in the study
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: IV TXA alone
One ampule of 500mg/ml tranexamic acid(TXA) inj is injected intravenously during operation after box cutting procedure(before tourniquet deflation).
Additionally, 1 ampule of TXA is administrated 3 hours after first injection on the day of operation.
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On the day of operation, same dose of IV tranexamic acid(TXA) is given to all subjects in three study groups.
Oral TXA is given from postoperative day 1 only to experimental groups.
Duration of oral TXA administration is different between two experimental groups.
(5 days in "IV TXA and Oral TXA 5 days group" and 2 days in "IV TXA and Oral TXA 2 days group")
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Экспериментальный: IV TXA and Oral TXA 5 days
One ampule of 500mg/ml tranexamic acid(TXA) inj is injected intravenously during operation after box cutting procedure(before tourniquet deflation). Additionally, 1 ampule of TXA is administrated 3 hours after first injection on the day of operation. Two 250mg capsules of oral TXA(Transamin Cap) is given three times a day, 30 minutes after each meal, from postoperative day 1 to day 5. |
On the day of operation, same dose of IV tranexamic acid(TXA) is given to all subjects in three study groups.
Oral TXA is given from postoperative day 1 only to experimental groups.
Duration of oral TXA administration is different between two experimental groups.
(5 days in "IV TXA and Oral TXA 5 days group" and 2 days in "IV TXA and Oral TXA 2 days group")
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Экспериментальный: IV TXA and Oral TXA 2 days
One ampule of 500mg/ml tranexamic acid(TXA) inj is injected intravenously during operation after box cutting procedure(before tourniquet deflation). Additionally, 1 ampule of TXA is administrated 3 hours after first injection on the day of operation. Two 250mg capsules of oral TXA(Transamin Cap) is given three times a day, 30 minutes after each meal, from postoperative day 1 to day 2. |
On the day of operation, same dose of IV tranexamic acid(TXA) is given to all subjects in three study groups.
Oral TXA is given from postoperative day 1 only to experimental groups.
Duration of oral TXA administration is different between two experimental groups.
(5 days in "IV TXA and Oral TXA 5 days group" and 2 days in "IV TXA and Oral TXA 2 days group")
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change from preoperative hemoglobin at day 2
Временное ограничение: Preop. day 1 to postop. day 2
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Hemoglobin (g/dL)
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Preop. day 1 to postop. day 2
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Change from preoperative hemoglobin at day 6
Временное ограничение: Preop. day 1 to postop. day 6
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Hemoglobin (g/dL)
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Preop. day 1 to postop. day 6
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Transfusion rate and amount
Временное ограничение: Postoperative day 0 to day 6
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transfusion trigger: packed red blood cell(RBC) 1 pack is given if Hb < 7 or 7 ≤ Hb< 8 with symptom of anemia
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Postoperative day 0 to day 6
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Complications
Временное ограничение: up to 6 week after operation
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CT angiography on postoperative day 6 for evaluation of deep vein thrombosis, Pulmonary embolism, superficial or deep infection, and other complications are assessed clinically.
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up to 6 week after operation
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Calculated Blood loss
Временное ограничение: Postop. day 6
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Based on predicted blood volume and hemoglobin balance
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Postop. day 6
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Соавторы и исследователи
Следователи
- Главный следователь: Seung-Baik Kang, MD, PhD, SMG-SNU Boramae Medical Center
Публикации и полезные ссылки
Общие публикации
- Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.
- Pilbrant A, Schannong M, Vessman J. Pharmacokinetics and bioavailability of tranexamic acid. Eur J Clin Pharmacol. 1981;20(1):65-72. doi: 10.1007/BF00554669.
- Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989.
- Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.
- Wu Q, Zhang HA, Liu SL, Meng T, Zhou X, Wang P. Is tranexamic acid clinically effective and safe to prevent blood loss in total knee arthroplasty? A meta-analysis of 34 randomized controlled trials. Eur J Orthop Surg Traumatol. 2015 Apr;25(3):525-41. doi: 10.1007/s00590-014-1568-z. Epub 2014 Nov 28.
- Irwin A, Khan SK, Jameson SS, Tate RC, Copeland C, Reed MR. Oral versus intravenous tranexamic acid in enhanced-recovery primary total hip and knee replacement: results of 3000 procedures. Bone Joint J. 2013 Nov;95-B(11):1556-61. doi: 10.1302/0301-620X.95B11.31055.
- Lin C, Qi Y, Jie L, Li HB, Zhao XC, Qin L, Jiang XQ, Zhang ZH, Ma L. Is combined topical with intravenous tranexamic acid superior than topical, intravenous tranexamic acid alone and control groups for blood loss controlling after total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2016 Dec;95(51):e5344. doi: 10.1097/MD.0000000000005344. Erratum In: Medicine (Baltimore). 2017 Feb 17;96(7):e6208.
- Li JF, Li H, Zhao H, Wang J, Liu S, Song Y, Wu HF. Combined use of intravenous and topical versus intravenous tranexamic acid in primary total knee and hip arthroplasty: a meta-analysis of randomised controlled trials. J Orthop Surg Res. 2017 Feb 2;12(1):22. doi: 10.1186/s13018-017-0520-4.
- Cankaya D, Dasar U, Satilmis AB, Basaran SH, Akkaya M, Bozkurt M. The combined use of oral and topical tranexamic acid is a safe, efficient and low-cost method in reducing blood loss and transfusion rates in total knee arthroplasty. J Orthop Surg (Hong Kong). 2017 Jan;25(1):2309499016684725. doi: 10.1177/2309499016684725.
- Benoni G, Lethagen S, Fredin H. The effect of tranexamic acid on local and plasma fibrinolysis during total knee arthroplasty. Thromb Res. 1997 Feb 1;85(3):195-206. doi: 10.1016/s0049-3848(97)00004-2. Erratum In: hromb Res 1997 Oct 15;88(2):251.
- Blanie A, Bellamy L, Rhayem Y, Flaujac C, Samama CM, Fontenay M, Rosencher N. Duration of postoperative fibrinolysis after total hip or knee replacement: a laboratory follow-up study. Thromb Res. 2013 Jan;131(1):e6-e11. doi: 10.1016/j.thromres.2012.11.006. Epub 2012 Nov 26.
- Reikeras O, Clementsen T. Time course of thrombosis and fibrinolysis in total knee arthroplasty with tourniquet application. Local versus systemic activations. J Thromb Thrombolysis. 2009 Nov;28(4):425-8. doi: 10.1007/s11239-008-0299-6. Epub 2008 Dec 6.
- Nielsen CS, Jans O, Orsnes T, Foss NB, Troelsen A, Husted H. Combined Intra-Articular and Intravenous Tranexamic Acid Reduces Blood Loss in Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. J Bone Joint Surg Am. 2016 May 18;98(10):835-41. doi: 10.2106/JBJS.15.00810.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SNUBMC_2017001
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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