Transfusion in Cardiac Valve Surgery
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: Restrictive Transfusion Strategy, Liberal Transfusion Strategy.
- Кому может быть актуально
- Состояния в реестре: Cardiac Surgery With Cardiopulmonary Bypass, Valve Heart Disease. Базовые параметры: 18 лет — 80 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
- 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
A Multicenter Prospective, Randomized Controlled Study of Different Transfusion Thresholds in Cardiac Valve Surgery
Обзор
This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups.
Подробное описание
Patients are randomly assigned to restrictive-threshold group and liberal-threshold group before cardiac group. Patients are included in this research when their Hct meets 24% during CPB.
Arterial blood gas analysis will be done in 0.5h, 1.5h, 2.5h, 3.5h...after CPB start and 0.5h before CPB finish.
Arterial blood gas analysis will be done every 4h in intensive care unit(ICU) and everyday in general ward.
Restrictive-threshold group: The transfusion threshold is Hemoglobin(Hb) ≤ 6.0g/dL or Hct ≤ 18% during CPB; postoperative Hb ≤ 7.0g/dL or Hct ≤ 21% in ICU or general ward.
Liberal-threshold group: The transfusion threshold is Hb ≤ 8.0g/dL or Hct ≤ 24% during CPB; postoperative Hb ≤ 10.0g/dL or Hct ≤ 30% in ICU or general ward.
If the Hb or Hct fall below the threshold at any time, 2 unit of blood cells is administered as soon as possible. Test Hb or Hct again, if is under the threshold 2 unit blood cells will be given until reach the threshold.
Вмешательства
- Другое Restrictive Transfusion Strategy
Blood transfusion at HCT less than 21% or Hb less than 6.0g/dL during CPB, at HCT less than 21% or Hb less than 7.0g/dL in ICU or general ward after surgery - Другое Liberal Transfusion Strategy
Blood transfusion at HCT less than 24% or Hb less than 8.0g/dL during CPB, at HCT less than 30% or Hb less than 10.0g/dL in ICU or general ward after surgery
Первичные конечные точки
- A composite of postoperative morbidity and mortality [Срок оценки: Postoperative 6 months]
Вторичные конечные точки (11)
- Rate of reoperation [Срок оценки: Postoperative 6 months]
- Length of ICU Stays [Срок оценки: From date of the end of operation until the date of discharging from ICU or date of death from any cause, whichever comes first, assessed up to 2 months.]
- Length of Postoperative Hospital Stay [Срок оценки: From date of discharging from ICU until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 2 months.]
- Number of Blood Transfusion [Срок оценки: From date of beginning of surgery until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 3 months.]
- Duration of mechanical ventilation [Срок оценки: From date of the end of surgery until the date of discharging from ICU or date of death from any cause, whichever comes first, assessed up to 2 months.]
- Postoperative thoracic fluid volume in the first 24 hours [Срок оценки: The first 24 hours after surgery]
- Number of participants with postoperative atrial fibrillation [Срок оценки: Postoperative 6 months]
- Number of participants with new-onset renal failure with dialysis [Срок оценки: Postoperative 6 months]
- Number of participants with acute kidney injury [Срок оценки: Postoperative 6 months]
- Number of participants with delirium [Срок оценки: Postoperative 6 months]
- Hospitalization expense [Срок оценки: From date of being admitted to hospital until the date of discharging from hospital or date of death from any cause, whichever comes first, assessed up to 3 months]
Критерии участия
Критерии включения
- All cardiac valve surgical patients undergoing CPB, isolated valve procedures Informed consent obtained
Критерии исключения
- Pregnant or maternal women Age less than 18 years or more than 80 years Undergo coronary artery bypass or large cardiac vessels procedure Emergencies Have been attended other researches Unable to receive blood for religious reasons Drug addict or malignant tumor patient
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
- Двойное слепое
- Основная цель
- Другое
Центры проведения
Китай · 1 центр
- Guangdong Provincial People's Hospital — Гуанчжоу
Идентификаторы
NCT: NCT06332547 · TICVS