POASAC Study (Preoperative Anemia Severity and Classification Study)

Официальное название

Impact of Preoperative Anemia Severity and Classification on Perioperative Oxygen Supply-Demand Imbalance-Related Complications--A Prospective Observational Multi-center Cohort Study

Обзор

The goal of this observational study focuses on the effect of different preoperative anemia status on perioperative complications in patients under moderate- to high-risk surgery. Different anemia types conclude iron-deficiency anemia(IDA), anemia of chronic disease/anemia of inflammation(ACD/AI), and combined anemia.The main question it aims to answer is whether there is a difference in the incidence of complication related to oxygen supply and demand imbalance in patients with IDA, ACD/AI or combined anemia. Patients without preoperative anemia will be recruited as the control group for secondary outcome analysis, which is whether there is a difference in the incidence of complication related to oxygen supply and demand imbalance in patients with or without anemia.

Подробное описание

The investigators aim to screen patients according to including and excluding criteria. According to the hemoglobin level, if the patient is anemia, the investigators will offer some lab tests for serum iron, transferrin saturation, C-reactive protein to classify different anemia status. Besides, the investigators will include patients without anemia in a 2:1 ration of anemia to non-anemia. The perioperative assessment and follow-up are the same for all the included patients.

Первичные конечные точки

• postoperative complications related to oxygen supply and demand imbalance [Срок оценки: before discharge or until seven days after surgery]

Вторичные конечные точки (6)

• The incidence of post complications related to oxygen supply and demand imbalance in patients with or without anemia [Срок оценки: before discharge or seven days after surgery]
• Postoperative functional disability [Срок оценки: 1 month, 6 months and 1 year after surgery]
• Cognitive function decline [Срок оценки: 1 month, 6 months and 1 year after surgery]
• RBC Transfusion rate [Срок оценки: From date of surgery until discharge day, assessed up to 4 weeks]
• Length of hospital stay [Срок оценки: From date of surgery until discharge day, assessed up to 4 weeks]
• Severe complication [Срок оценки: before discharge, 1 month, 6 months and 1 year after surgery]

Критерии участия

Критерии включения

• age 18 years or older
• scheduled for elective moderate- to high-risk surgery other than intracranial and cardiac surgery
• predicted surgery time longer than 1 hour and hospital stay longer than 24 hours
• understand and agree to participate

Критерии исключения

• pregnant
• live at areas higher than 2,500 meters above sea level
• with hematological diseases other than anemia
• with severe comorbidities that might interfere outcome assessment, like uremia, dementia, and so on
• can't cooperate or communicate, or reject to sign informed consent form

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 11 центров

• Department of Anesthesiology, First Affiliated Hospital of Wannan Medical College — Wuhu
• Beijing Longfu Hospital (Beijing Geriatric Hospital of Integrated Traditional Chinese and — Пекин
• Anesthesiology Department, Beijing NO.6 Hospital — Пекин
• BeiJing Hepingli Hospital — Пекин
• Beijing Puren Hospital — Пекин
• Peking Union Medical College Hospital — Пекин
• Science and Education Department, Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou
• Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University — Zunyi
• … и ещё 3 центра

Идентификаторы

NCT: NCT06499974 · K3049

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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