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NCT Number: NCT06499974

POASAC Study (Preoperative Anemia Severity and Classification Study)

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. The incidence of post complications related to oxygen supply and demand imbalance in patients with or without anemia

    Time frame: 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)

  2. Postoperative functional disability

    Time frame: 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.

  3. Cognitive function decline

    Time frame: 1 month, 6 months and 1 year after surgery

    The modified Telephone Interview for Cognitive Status(TICS-m) is used for cognitive function assessment.

  4. RBC Transfusion rate

    Time frame: From date of surgery until discharge day, assessed up to 4 weeks

    The above information can be got according to the medical record

  5. Length of hospital stay

    Time frame: From date of surgery until discharge day, assessed up to 4 weeks

    The above information can be got according to the medical record

  6. Severe complication

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Che

CONTACT

[email protected]

15901045120

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 15, 2024
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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