POASAC Study (Preoperative Anemia Severity and Classification Study)
- Conditions
- Anemia
- Registration Number
- NCT06499974
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method postoperative complications related to oxygen supply and demand imbalance before discharge or until seven days after surgery The occurrence of any of the following complications is considered a positive outcome, which include myocardial injury after non cardiac surgery(MINS), acute kidney injury(AKI), neurological damage such as stroke and delayed neurocognitive recovery(DNR)
- Secondary Outcome Measures
Name Time Method Postoperative functional disability 1 month, 6 months and 1 year after surgery The World Health Organization Disability Assessment Schedule 2.0 (WHO DAS2.0) is used for disability assessment.
The incidence of post complications related to oxygen supply and demand imbalance in patients with or without anemia before discharge or seven days after surgery The occurrence of any of the following complications is considered a positive outcome, which include myocardial injury after non cardiac surgery(MINS), acute kidney injury(AKI), neurological damage such as stroke and delayed neurocognitive recovery(DNR)
RBC Transfusion rate From date of surgery until discharge day, assessed up to 4 weeks The above information can be got according to the medical record
Length of hospital stay From date of surgery until discharge day, assessed up to 4 weeks The above information can be got according to the medical record
Cognitive function decline 1 month, 6 months and 1 year after surgery The modified Telephone Interview for Cognitive Status(TICS-m) is used for cognitive function assessment.
Severe complication before discharge, 1 month, 6 months and 1 year after surgery Evaluated according to Clavien-Dindo classification, level three to five are defined as severe complication.
Trial Locations
- Locations (8)
Department of Anesthesiology, First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Beijing Longfu Hospital (Beijing Geriatric Hospital of Integrated Traditional Chinese and Western Medicine)
🇨🇳Beijing, Beijing, China
Anesthesiology Department, Beijing NO.6 Hospital
🇨🇳Beijing, Beijing, China
BeiJing Hepingli Hospital
🇨🇳Beijing, Beijing, China
Beijing Puyin Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Science and Education Department, Zhangzhou Municipal Hospital of Fujian Province
🇨🇳Zhangzhou, Fujian, China
Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China