NCT07092683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,683

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
Last Updated

January 5, 2026

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 20, 2025

Last Update Submit

December 31, 2025

Conditions

AnemiaCardiac SurgeryTransfusionMediation

Outcome Measures

Primary Outcomes (1)

  • 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.

    From the start of surgery to 30 days after surgery

Secondary Outcomes (6)

  • Incidence of Acute Kidney Injury (AKI)

    From the start of surgery to 30 days after surgery

  • Incidence of Neurological Complications

    From the start of surgery to 30 days after surgery

  • Incidence of Infections

    From the start of surgery to 30 days after surgery

  • Incidence of Pulmonary Complications

    From the start of surgery to 30 days after surgery

  • Length of Hospital Stay

    From the start of surgery to 30 days after surgery

  • +1 more secondary outcomes

Study Arms (2)

anemia

Other: anemia

nonanemia

Other: nonanemia

Interventions

anemiaOTHER

preoperative anemia

anemia
nonanemiaOTHER

preoperative nonanemia

nonanemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 330100, China

Location

Related Publications (3)

  • 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.

    PMID: 26349842RESULT

  • Horvath 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.

    PMID: 23647857RESULT

  • Transfusion 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.

    PMID: 31702696RESULT

MeSH Terms

Conditions

AnemiaNegotiating

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesCommunicationBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2025

First Posted

July 30, 2025

Study Start

January 1, 2025

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

January 5, 2026

Record last verified: 2025-07

Locations

CN(1)