Impact of Preoperative Anemia Severity and Classification on Perioperative Oxygen Supply-Demand Imbalance-Related Complications--A Prospective Observational Multi-center Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 11
- Primary Endpoint
- postoperative complications related to oxygen supply and demand imbalance
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
postoperative complications related to oxygen supply and demand imbalance
Time Frame: 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 Outcomes
- Postoperative functional disability(1 month, 6 months and 1 year after surgery)
- 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)
- RBC Transfusion rate(From date of surgery until discharge day, assessed up to 4 weeks)
- Length of hospital stay(From date of surgery until discharge day, assessed up to 4 weeks)
- Cognitive function decline(1 month, 6 months and 1 year after surgery)
- Severe complication(before discharge, 1 month, 6 months and 1 year after surgery)