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Mediation Analysis in Cardiac Surgery

Mediating Role of Intraoperative Red Blood Cell Transfusion in the Relationship Between Preoperative Anaemia and Postoperative Complications in Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07092683
Acronym
MACS
Enrollment
13683
Registered
2025-07-30
Start date
2025-01-01
Completion date
2025-05-01
Last updated
2026-01-05

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

Conditions

Anemia, Cardiac Surgery, Mediation, Transfusion

Brief 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. 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.

Interventions

OTHERanemia

preoperative anemia

OTHERnonanemia

preoperative nonanemia

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults aged 18 and older ; * Undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion criteria

* preoperative mechanical circulatory support * ASA physical status VI-V * unplanned intra-hospital reoperations * catheter-based valve replacements, * heart tumours, * stent implantation surgeries, * coronary angiography, * transvascular valve clamping, * tetralogy of Fallot, * ventricular aneurysms, * cardiomyopathies,

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative ComplicationsFrom the start of surgery to 30 days after surgeryThe 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.

Secondary

MeasureTime frameDescription
Incidence of Neurological ComplicationsFrom the start of surgery to 30 days after surgeryOccurrence of neurological complications such as postoperative delirium, stroke, or cognitive dysfunction, assessed based on clinical diagnosis and relevant neurocognitive evaluation.
Incidence of InfectionsFrom the start of surgery to 30 days after surgeryOccurrence of postoperative infections including surgical site infection, bloodstream infection, and pneumonia, diagnosed according to CDC criteria.
Incidence of Acute Kidney Injury (AKI)From the start of surgery to 30 days after surgeryOccurrence of AKI during postoperative hospitalization, defined according to the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.
Length of Hospital StayFrom the start of surgery to 30 days after surgeryDuration of postoperative hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge.
Total Hospitalization CostFrom the start of surgery to 30 days after surgeryTotal 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.
Incidence of Pulmonary ComplicationsFrom the start of surgery to 30 days after surgeryOccurrence of pulmonary complications including pneumonia, pleural effusion, atelectasis, or need for prolonged mechanical ventilation (\>48 hours postoperatively).

Countries

China

Outcome results

None listed

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