RecruitingNCT07699016

Appropriateness of Hemostatic Agent Use in Cardiovascular Surgery (HAEMOVAX)

Evaluation of Appropriateness in the Use of Hemostatic Agents in Cardiovascular Surgery: A Mixed-Methods Single-Center Observational Study


Sponsor

University of Milan

Enrollment

15 participants

Start Date

Jul 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

Hemostatic agents are widely used in cardiac and vascular surgery to support intraoperative bleeding control. Despite their clinical relevance and substantial economic impact, little is known about real-world patterns of use, adherence to evidence-based recommendations, and the alignment between clinicians' perceived knowledge and actual decision-making. HAEMOVAX is a single-center mixed-methods observational study conducted at IRCCS Galeazzi-Sant'Ambrogio Hospital, Milan, Italy. The study combines an anonymous survey of cardiovascular surgeons with a retrospective audit of institutional hemostatic agent consumption. The primary objective is to evaluate the appropriateness of hemostatic agent selection using a Knowledge-Practice Alignment Score (KPA-Score) derived from standardized clinical vignettes based on current EACTS and ESA recommendations. Secondary objectives include assessment of usage patterns, barriers to appropriate use, concordance between declared practice and real-world consumption, and opportunities for evidence-based standardization.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Physicians with a surgical role in the Departments of Cardiac Surgery or Vascular Surgery at IRCCS Galeazzi-Sant'Ambrogio, Milan Including attending surgeons, consultant surgeons, and surgical residents
  • Active participation in cardiovascular operative procedures during the study period (or within the preceding 12 months)
  • Employment at the study institution at the time of survey administration Willingness to participate and complete the anonymous structured questionnaire

Exclusion Criteria5

  • Non-surgical healthcare personnel (e.g., nurses, anesthesiologists, administrative staff, or allied health professionals)
  • Surgeons not involved in operative cardiovascular practice during the study period
  • External collaborators or visiting surgeons without regular clinical activity at the institution
  • Individuals who do not provide informed consent for participation in the anonymous survey
  • Questionnaires with missing or incomplete vignette responses preventing calculation of the KPA-Score

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Interventions

OTHERobservational study

Cross-sectional structured survey assessing knowledge-practice alignment in the use of hemostatic agents, combined with retrospective institutional audit of product consumption. No therapeutic or experimental intervention is administered.


Locations(1)

IRCCS Galeazzi Sant'Ambrogio Hospital

Milan, MI, Italy

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NCT07699016


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