AnemiaNCT06499974
POASAC Study (Preoperative Anemia Severity and Classification Study)
An observational study of Anemia, run by Peking Union Medical College Hospital at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia
- How many people
- 1,000 participants
- Where
- 11 sitesChina
- Study dates
- 2 Aug 2024to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are 18 years or older scheduled for moderate- or high-risk surgery will be included in our study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Beijing Longfu Hospital (Beijing Geriatric Hospital of Integrated Traditional Chinese and Western Medicine)
Beijing, Beijing Municipality, 100010
Hao Zhang, 86-13910558885, 13910558885@163.com
- Recruiting
Anesthesiology Department, Beijing NO.6 Hospital
Beijing, Beijing Municipality
Fangling Tian, 13683306276, fanglingtian0814@163.com
- Recruiting
BeiJing Hepingli Hospital
Beijing, Beijing Municipality
Anesthesia department, 86-010-58043226, meteorstar00@163.com
- Recruiting
Beijing Puren Hospital
Beijing, Beijing Municipality
science and educaction section, +86 01087928289, 13522773307@163.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Lu Che, 15901045120, tracymaobao@126.com
- Recruiting
Department of Anesthesiology, Chifeng Municipal Hospital
Chifeng, Inner Mongolia
Jiannan Song, 8618047660879, songjiannan321@163.com
- Recruiting
Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Junhui Li, 8613848338502, mzljh1132689425@163.com
- Recruiting
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia
Zhihui Zhao, 18004712242, Doctorzzh2242@163.com
- Recruiting
Department of Anesthesiology, First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
Meijing Lu, 13955367332, 619466076@qq.com
- Recruiting
Science and Education Department, Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian
Haolin Shen, 13850580410, zzfhkjk@126.com
- Recruiting
Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563003
Xuejiao Dou, 13984289768, 411287860@qq.com
About this 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
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.
Read the 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.
- Conditions
- Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications related to oxygen supply and demand imbalance
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)
Measured: before discharge or until seven days after surgery
Secondary outcomes (6)
The incidence of post complications related to oxygen supply and demand imbalance in patients with or without anemia
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)
Measured: before discharge or seven days after surgery
Postoperative functional disability
The World Health Organization Disability Assessment Schedule 2.0 (WHO DAS2.0) is used for disability assessment.
Measured: 1 month, 6 months and 1 year after surgery
Cognitive function decline
The modified Telephone Interview for Cognitive Status(TICS-m) is used for cognitive function assessment.
Measured: 1 month, 6 months and 1 year after surgery
RBC Transfusion rate
The above information can be got according to the medical record
Measured: From date of surgery until discharge day, assessed up to 4 weeks
Length of hospital stay
The above information can be got according to the medical record
Measured: From date of surgery until discharge day, assessed up to 4 weeks
Severe complication
Evaluated according to Clavien-Dindo classification, level three to five are defined as severe complication.
Measured: before discharge, 1 month, 6 months and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start2 Aug 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499974
- Sponsor's protocol ID
- K3049
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Anemia Severity and Classification on Perioperative Oxygen Supply-Demand Imbalance-Related Complications--A Prospective Observational Multi-center Cohort Study
- ClinicalTrials.gov ID
- NCT06499974
- Acronym / sponsor ID
- K3049
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are 18 years or older scheduled for moderate- or high-risk surgery will be included in our study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
6 secondary outcomes
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
Postoperative functional disability
Time frame: 1 month, 6 months and 1 year after surgery
Cognitive function decline
Time frame: 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
Length of hospital stay
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Peking Union Medical College Hospital at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Che (15901045120, tracymaobao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications related to oxygen supply and demand imbalance (time frame: before discharge or until seven days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.