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NCT Number: NCT07092683

Mediation Analysis 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.

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Key information

Conditions

Anemia Behavior Cardiac Surgery Communication Hematologic Diseases Hemic and Lymphatic Diseases Mediation Negotiating Transfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 330100, China

Who can participate

Healthy volunteers accepted: No

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

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,

Treatment and study plan

Anemia

Other

preoperative anemia

nonanemia

Other

preoperative nonanemia

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of Acute Kidney Injury (AKI)

    Time frame: From the start of surgery to 30 days after surgery

    Occurrence of AKI during postoperative hospitalization, defined according to the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.

  2. Incidence of Neurological Complications

    Time frame: From the start of surgery to 30 days after surgery

    Occurrence of neurological complications such as postoperative delirium, stroke, or cognitive dysfunction, assessed based on clinical diagnosis and relevant neurocognitive evaluation.

  3. Incidence of Infections

    Time frame: From the start of surgery to 30 days after surgery

    Occurrence of postoperative infections including surgical site infection, bloodstream infection, and pneumonia, diagnosed according to CDC criteria.

  4. Incidence of Pulmonary Complications

    Time frame: From the start of surgery to 30 days after surgery

    Occurrence of pulmonary complications including pneumonia, pleural effusion, atelectasis, or need for prolonged mechanical ventilation (>48 hours postoperatively).

  5. Length of Hospital Stay

    Time frame: From the start of surgery to 30 days after surgery

    Duration of postoperative hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge.

  6. Total Hospitalization Cost

    Time frame: From the start of surgery to 30 days after surgery

    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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: MACS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jan 5, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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