- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01597232
Clinic Trial for West China Perioperative Transfusion Score (WCPTS) (WCPTS)
Effect of West China Perioperative Transfusion Score (WCPTS) on Red Blood Cells Transfusion in Patients Undergoing Major Surgery: a Prospective, Multicenter, Randomized Controlled Trial
Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.
Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen, core temperature, and angina. To verify this hypothesis, the investigators present West China Perioperative Transfusion Score (WCPTS) for the trigger of transfusion according to the patient's history and monitoring parameters, and the investigators design a randomized controlled clinical trial to test this score.
Обзор исследования
Статус
Подробное описание
Surgery and trauma are the most common reasons for major blood loss, and blood transfusion provide guarantee for massive hemorrhagic surgery, especially orthopedic, cardiac, liver, and gynecologic procedures. On the other hand, blood transfusion is associated with many risks including hemolytic and nonhemolytic reactions, transfusion related acute lung injury (TRALI), and others. Besides, blood is insufficient worldwide. How to eliminate allogeneic blood transfusion is an important part in clinical practice.
Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.
Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen for maintaining spO2≧95%, core temperature, and angina.
Peri-Operative Transfusion Trigger Score, POTTS The initial score is 6. If a patient's cardiac output is normal without infusion of adrenalin, his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has no angina, his score is 6.
If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate ≤0.05μg/kg.min, or his spO2 is maintained more than 95% with 36~50% FiO2, or his core temperature is between 38℃ to 40℃, or chest pain due to exercise,manual labor,or excitement, his score should be added 1 point for each problem.
If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate >0.06μg/kg.min, or his spO2 is maintained more than 95% with >51% FiO2, or his core temperature is >40℃, or sudden onset of chest pain at rest, his score should be added 2 point for each problem.
The initial POTTS score is 6, and the patient's score is calculated by the sum of each item.
Score 6:The transfusion trigger is 6g/dL, and the the patient's Hemoglobin level should be maintained not less than 6g/dL.
Score 7:The transfusion trigger is 7g/dL, and the the patient's Hemoglobin level should be maintained not less than 7g/dL.
Score 8:The transfusion trigger is 8g/dL, and the the patient's Hemoglobin level should be maintained not less than 8g/dL.
Score 9:The transfusion trigger is 9g/dL, and the the patient's Hemoglobin level should be maintained not less than 9g/dL.
Score 10 or >10:The transfusion trigger is 10g/dL, and the the patient's Hemoglobin level should be maintained not less than 10g/dL.
For example, if a patient need ≤0.05μg/kg.min adrenalin to maintain his normal cardiac output (+1), his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has sudden onset of chest pain at rest (+2), his POTTS score could be calculated as 6 +1 (≤0.05μg/kg.min adrenalin to maintain his normal cardiac output) +2 (sudden onset of chest pain at rest), and his POTTS score is 9. That means this patient's transfusion trigger is 9g/dL, and his hemoglobin level should be maintained above 9 at this situation.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Sichuan
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Chengdu, Sichuan, Китай, 610041
- Department of Anesthesiology, West China Hospital, Sichuan University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Height of usual place of residence less than 2,500 metres above sea level
- Perioperative hemoglobin level possibly less than 10g/dL
Exclusion Criteria:
- Emergency operation
- ASA classification V or VI
- Serious blood system diseases
- Dysfunction of hemoglobin
- Hypervolemic hemodilution
- Tumor metastasis
- Psychopathy
- Refuse to sign consent
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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Экспериментальный: Transfusion trigger based on WCPTS
Determination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on WCPTS.
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Определение того, нуждается ли пациент в переливании эритроцитарной массы или какой уровень гемоглобина следует поддерживать, основано на WCPTS.
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Активный компаратор: Hemoglobin level 10g/dL
The patient's hemoglobin level is maintained more than 10g/dL perioperatively.
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The patient's hemoglobin level is maintained more than 10g/dL perioperatively
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Активный компаратор: Transfusion trigger based on experience
Determination of whether a patient need red blood cell transfusion or which hemoglobin level should be maintained is base on the physician's experience.
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Determination of whether the patient need red blood cell transfusion or which hemoglobin level should be maintained is based on the physician's experience
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of patients received red-cell
Временное ограничение: Up to 30 days postoperatively
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Proportion of patients received red-cell during peri-operative period
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Up to 30 days postoperatively
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Composite of in-hospital complications and all-cause mortality by day-30
Временное ограничение: Up to 30 days postoperatively
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Composite of in-hospital complications and all-cause mortality by day-30, and complications were defined as the serious ones that cause prolonged hospitalization, or life threatening, but could get recovery after intense treatment during hospitalization, or life threatening, resulting in significantly decreased quality of life.
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Up to 30 days postoperatively
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidences of in-hospital infectious complications.
Временное ограничение: Up to 30 days postoperatively
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Infectious complications were defined as infection at any site, such as pulmonary infection, urinary infection, etc.
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Up to 30 days postoperatively
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Intensive Care Unit (ICU) admission rate
Временное ограничение: Up to 30 days postoperatively
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Proportion of patients with ICU admission
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Up to 30 days postoperatively
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Length of hospital stay (LOS)
Временное ограничение: Up to 30 days postoperatively
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LOS was defined as the time frame from the day of hospital admission to discharge from the hospital (unit: days).
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Up to 30 days postoperatively
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Hemoglobin level at different time points
Временное ограничение: Up to 30 days postoperatively
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Hb level was measured at the time points as follows: before operation, completion of operation, 24hrs after operation, before discharge, and before all red cells transfusion
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Up to 30 days postoperatively
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Cost of transfusion and hospitalization
Временное ограничение: Up to 30 days postoperatively
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Allogeneic blood cost and total in-hospital cost
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Up to 30 days postoperatively
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SF-8 questionnaire
Временное ограничение: Up to one year postoperatively
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Follow-up of quality of life during one year after operation
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Up to one year postoperatively
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Healing status of surgical incision
Временное ограничение: Up to 30 days postoperatively
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Healing status of surgical incision was divided into grade Ⅰ, Ⅱ, and Ⅲ. Grade Ⅰ was defined as the wound healing nicely without any adverse reaction, grade Ⅱ was defined as the inflammatory wound without the need of re-incision, and grade Ⅲ was defined as the wound suppurated with the need of re-incision for clearance.
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Up to 30 days postoperatively
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All-cause mortality during 1-year after operation
Временное ограничение: Up to one year postoperatively
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All-cause mortality by day-60, day-180 and 1-year after operation
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Up to one year postoperatively
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Ren Liao, M.D., Department of Anesthesiology, West China Hospital, Sichuan University
- Главный следователь: Jin Liu, M.D., Department of Anesthesiology, West China Hospital, Sichuan University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
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
- WCPTS120508
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