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POASAC Study (Preoperative Anemia Severity and Classification Study)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06499974
Enrollment
1000
Registered
2024-07-15
Start date
2024-08-02
Completion date
2027-12-31
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
postoperative complications related to oxygen supply and demand imbalancebefore discharge or until seven days after surgeryThe 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

MeasureTime frameDescription
Postoperative functional disability1 month, 6 months and 1 year after surgeryThe World Health Organization Disability Assessment Schedule 2.0 (WHO DAS2.0) is used for disability assessment.
Cognitive function decline1 month, 6 months and 1 year after surgeryThe modified Telephone Interview for Cognitive Status(TICS-m) is used for cognitive function assessment.
The incidence of post complications related to oxygen supply and demand imbalance in patients with or without anemiabefore discharge or seven days after surgeryThe 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)
Length of hospital stayFrom date of surgery until discharge day, assessed up to 4 weeksThe above information can be got according to the medical record
Severe complicationbefore discharge, 1 month, 6 months and 1 year after surgeryEvaluated according to Clavien-Dindo classification, level three to five are defined as severe complication.
RBC Transfusion rateFrom date of surgery until discharge day, assessed up to 4 weeksThe above information can be got according to the medical record

Countries

China

Contacts

Primary ContactLu Che
tracymaobao@126.com15901045120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026