POASAC Study (Preoperative Anemia Severity and Classification Study)

November 28, 2025 updated by: Peking Union Medical College Hospital

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Wuhu, Anhui, China
        • Recruiting
        • Department of Anesthesiology, First Affiliated Hospital of Wannan Medical College
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100010
        • Recruiting
        • Beijing Longfu Hospital (Beijing Geriatric Hospital of Integrated Traditional Chinese and Western Medicine)
        • Contact:
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Anesthesiology Department, Beijing NO.6 Hospital
        • Contact:
      • Beijing, Beijing Municipality, China
        • Recruiting
        • BeiJing Hepingli Hospital
        • Contact:
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Puren Hospital
        • Contact:
    • Fujian
      • Zhangzhou, Fujian, China
        • Recruiting
        • Science and Education Department, Zhangzhou Municipal Hospital of Fujian Province
        • Contact:
    • Guizhou
      • Zunyi, Guizhou, China, 563003
        • Recruiting
        • Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China
        • Recruiting
        • Department of Anesthesiology, Chifeng Municipal Hospital
        • Contact:
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • Inner Mongolia People's Hospital
        • Contact:
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
IDA
patients with iron-deficiency anemia
ACD/AI
patients with anemia of chronic disease/anemia of inflammation
Combined anemia
patients with IDA and ACD/AI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
before discharge or until seven days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
before discharge or seven days after surgery
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.
1 month, 6 months and 1 year after surgery
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.
1 month, 6 months and 1 year after surgery
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
From date of surgery until discharge day, assessed up to 4 weeks
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
From date of surgery until discharge day, assessed up to 4 weeks
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.
before discharge, 1 month, 6 months and 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 7, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K3049

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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