Clinical trial NCT06499974: POASAC Study (Preoperative Anemia Severity and Classification Study)
Official title: Impact of Preoperative Anemia Severity and Classification on Perioperative Oxygen Supply-Demand Imbalance-Related Complications--A Prospective Observational Multi-center Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anemia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are 18 years or older scheduled for moderate- or high-risk surgery will be included in our study.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: postoperative complications related to oxygen supply and demand imbalance
timeFrame: before discharge or until seven days after surgery
Secondary outcomes:
measure: The incidence of post complications related to oxygen supply and demand imbalance in patients with or without anemia
timeFrame: before discharge or seven days after surgery
measure: Postoperative functional disability
timeFrame: 1 month, 6 months and 1 year after surgery
measure: Cognitive function decline
timeFrame: 1 month, 6 months and 1 year after surgery
measure: RBC Transfusion rate
timeFrame: From date of surgery until discharge day, assessed up to 4 weeks
measure: Length of hospital stay
timeFrame: From date of surgery until discharge day, assessed up to 4 weeks
measure: Severe complication
timeFrame: before discharge, 1 month, 6 months and 1 year after surgery
Other outcomes:
Locations:
city: Wuhu
country: China
facility: Department of Anesthesiology, First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Longfu Hospital (Beijing Geriatric Hospital of Integrated Traditional Chinese and Western Medicine)
state: Beijing
city: Beijing
country: China
facility: Anesthesiology Department, Beijing NO.6 Hospital
state: Beijing
city: Beijing
country: China
facility: BeiJing Hepingli Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Puyin Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Zhangzhou
country: China
facility: Science and Education Department, Zhangzhou Municipal Hospital of Fujian Province
state: Fujian
city: Zunyi
country: China
facility: Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University
state: Guizhou
Study officials:
References: