AnemiaMACSNCT07092683
Mediation Analysis in Cardiac Surgery
An observational study of Anemia and Cardiac Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study investigates the mediating role of intraoperative allogeneic red blood cell transfusion in the relationship between preoperative anaemia and postoperative complications in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Cardiac Surgery, Transfusion
- What is being tested?
- anemia and nonanemia
- How many people
- 13,683 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients for inclusion were those aged 18 or older undergoing elective cardiac surgery with CPB support at West China Hospital (WCH) from 22 December 2010 to 1 July 2017, and at The Second affiliated Hospital of Zhejiang University (SAHZU) from 1 September 2013 to 31 December 2024.
Who may be able to join
- Adults aged 18 and older ；
- Undergoing elective cardiac surgery with cardiopulmonary bypass
Who cannot join
- preoperative mechanical circulatory support
- ASA physical status VI-V
- unplanned intra-hospital reoperations
- catheter-based valve replacements,
- heart tumours,
- stent implantation surgeries,
Show all 11Show fewer
- coronary angiography,
- transvascular valve clamping,
- tetralogy of Fallot,
- ventricular aneurysms,
- cardiomyopathies,
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 330100
About this study
Official title: Mediating Role of Intraoperative Red Blood Cell Transfusion in the Relationship Between Preoperative Anaemia and Postoperative Complications in Cardiac Surgery
This study investigates the mediating role of intraoperative allogeneic red blood cell transfusion in the relationship between preoperative anaemia and postoperative complications in patients undergoing cardiac surgery. Using mediation analysis methods, we aim to determine whether and to what extent intraoperative transfusion explains the association between preoperative anaemia and adverse postoperative outcomes. By elucidating this pathway, the study seeks to inform perioperative blood management strategies and support more personalized, risk-adapted approaches to minimize postoperative complications in anaemic patients undergoing cardiac procedures.
- Conditions
- Anemia, Cardiac Surgery, Transfusion, Mediation
- Being tested
- anemia, nonanemia
- Medical subject headings
- Anemia, Negotiating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anemiaOther
preoperative anemia
nonanemiaOther
preoperative nonanemia
| Study group | Role | What they receive |
|---|---|---|
| anemia | Not described Receives: Other: anemia | |
| nonanemia | Not described Receives: Other: nonanemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Complications
The primary outcome is the occurrence of any postoperative complications during the index hospitalization. Complications include, but are not limited to, acute kidney injury (AKI), neurological complications, infections, and pulmonary complications. These are assessed using standardized diagnostic criteria.
Measured: From the start of surgery to 30 days after surgery
Secondary outcomes (6)
Incidence of Acute Kidney Injury (AKI)
Occurrence of AKI during postoperative hospitalization, defined according to the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.
Measured: From the start of surgery to 30 days after surgery
Incidence of Neurological Complications
Occurrence of neurological complications such as postoperative delirium, stroke, or cognitive dysfunction, assessed based on clinical diagnosis and relevant neurocognitive evaluation.
Measured: From the start of surgery to 30 days after surgery
Incidence of Infections
Occurrence of postoperative infections including surgical site infection, bloodstream infection, and pneumonia, diagnosed according to CDC criteria.
Measured: From the start of surgery to 30 days after surgery
Incidence of Pulmonary Complications
Occurrence of pulmonary complications including pneumonia, pleural effusion, atelectasis, or need for prolonged mechanical ventilation (>48 hours postoperatively).
Measured: From the start of surgery to 30 days after surgery
Length of Hospital Stay
Duration of postoperative hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge.
Measured: From the start of surgery to 30 days after surgery
Total Hospitalization Cost
Total direct medical cost incurred during the index hospitalization, including surgical costs, intensive care, ward care, medications, laboratory and imaging studies, and blood transfusion-related expenses.
Measured: From the start of surgery to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jan 2025
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 13,683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092683
- Sponsor's protocol ID
- 20210655
- Acronym
- MACS
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fowler AJ, Ahmad T, Phull MK, Allard S, Gillies MA, Pearse RM. Meta-analysis of the association between preoperative anaemia and mortality after surgery. Br J Surg. 2015 Oct;102(11):1314-24. doi: 10.1002/bjs.9861.
PubMed 26349842Horvath KA, Acker MA, Chang H, Bagiella E, Smith PK, Iribarne A, Kron IL, Lackner P, Argenziano M, Ascheim DD, Gelijns AC, Michler RE, Van Patten D, Puskas JD, O'Sullivan K, Kliniewski D, Jeffries NO, O'Gara PT, Moskowitz AJ, Blackstone EH. Blood transfusion and infection after cardiac surgery. Ann Thorac Surg. 2013 Jun;95(6):2194-201. doi: 10.1016/j.athoracsur.2012.11.078. Epub 2013 May 3.
PubMed 23647857Transfusion of Red Blood Cells, Fresh Frozen Plasma, or Platelets Is Associated With Mortality and Infection After Cardiac Surgery in a Dose-Dependent Manner. Anesth Analg. 2020 Feb;130(2):e32. doi: 10.1213/ANE.0000000000004528.
PubMed 31702696
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediating Role of Intraoperative Red Blood Cell Transfusion in the Relationship Between Preoperative Anaemia and Postoperative Complications in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07092683
- Acronym / sponsor ID
- MACS / 20210655
- Conditions
- Anemia, Cardiac Surgery, Transfusion, Mediation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,683 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 30 Jul 2025 (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.
This study investigates the mediating role of intraoperative allogeneic red blood cell transfusion in the relationship between preoperative anaemia and postoperative complications in patients undergoing cardiac surgery. Using mediation analysis methods, we aim to determine whether and to what extent intraoperative transfusion explains the association between preoperative anaemia and adverse postoperative outcomes. By elucidating this pathway, the study seeks to inform perioperative blood management strategies and support more personalized, risk-adapted approaches to minimize postoperative complications in anaemic patients undergoing cardiac procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anemia | – | Other: anemia |
| nonanemia | – | Other: nonanemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients for inclusion were those aged 18 or older undergoing elective cardiac surgery with CPB support at West China Hospital (WCH) from 22 December 2010 to 1 July 2017, and at The Second affiliated Hospital of Zhejiang University (SAHZU) from 1 September 2013 to 31 December 2024.
Key inclusion criteria (2 listed)
- Adults aged 18 and older ；
- Undergoing elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (11 listed)
- preoperative mechanical circulatory support
- ASA physical status VI-V
- unplanned intra-hospital reoperations
- catheter-based valve replacements,
- heart tumours,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anemiapreoperative anemia | Other | anemia |
| nonanemiapreoperative nonanemia | Other | nonanemia |
Primary outcome
Incidence of Postoperative Complications
Time frame: From the start of surgery to 30 days after surgery
The primary outcome is the occurrence of any postoperative complications during the index hospitalization. Complications include, but are not limited to, acute kidney injury (AKI), neurological complications, infections, and pulmonary complications. These are assessed using standardized diagnostic criteria.
6 secondary outcomes
Incidence of Acute Kidney Injury (AKI)
Time frame: From the start of surgery to 30 days after surgery
Incidence of Neurological Complications
Time frame: From the start of surgery to 30 days after surgery
Incidence of Infections
Time frame: From the start of surgery to 30 days after surgery
Incidence of Pulmonary Complications
Time frame: From the start of surgery to 30 days after surgery
Length of Hospital Stay
Time frame: From the start of surgery to 30 days after surgery
Total Hospitalization Cost
Time frame: From the start of surgery to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Results publication: PubMed 26349842Fowler AJ, Ahmad T, Phull MK, Allard S, Gillies MA, Pearse RM. Meta-analysis of the association between preoperative anaemia and mortality after surgery. Br J Surg. 2015 Oct;102(11):1314-24. doi: 10.1002/bjs.9861.
- Results publication: PubMed 23647857Horvath KA, Acker MA, Chang H, Bagiella E, Smith PK, Iribarne A, Kron IL, Lackner P, Argenziano M, Ascheim DD, Gelijns AC, Michler RE, Van Patten D, Puskas JD, O'Sullivan K, Kliniewski D, Jeffries NO, O'Gara PT, Moskowitz AJ, Blackstone EH. Blood transfusion and infection after cardiac surgery. Ann Thorac Surg. 2013 Jun;95(6):2194-201. doi: 10.1016/j.athoracsur.2012.11.078. Epub 2013 May 3.
- Results publication: PubMed 31702696Transfusion of Red Blood Cells, Fresh Frozen Plasma, or Platelets Is Associated With Mortality and Infection After Cardiac Surgery in a Dose-Dependent Manner. Anesth Analg. 2020 Feb;130(2):e32. doi: 10.1213/ANE.0000000000004528.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Cardiac Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Complications (time frame: From the start of surgery to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07092683, which also lists 3 linked publications.
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 5 Jan 2026.