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Appropriateness of Hemostatic Agent Use in Cardiovascular Surgery (HAEMOVAX)

ConditionsHemostasisPerioperative BleedingCardiovascular SurgeryCardiac SurgeryVascular Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Milan

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study population includes all cardiovascular surgery staff (cardiac and vascular surgeons, including attending surgeons and residents) employed at IRCCS Galeazzi-Sant'Ambrogio, Milan. Participation is voluntary and anonymous. The study uses a census sampling approach, targeting the entire eligible professional population within the institution. No patient-level participants are included.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • observational study

    Other intervention

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Hemostatic agents usage assessment cohort1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants achieving a Knowledge-Practice Alignment Score (KPA-Score) ≥60%

The Knowledge-Practice Alignment Score (KPA-Score) is a study-defined measure representing the percentage of guideline-concordant responses across five standardized clinical vignettes assessing hemostatic agent selection. Scores range from 0% to 100%, with higher scores indicating greater concordance with current European Association for Cardio-Thoracic Surgery (EACTS) and European Society of Anaesthesiology and Intensive Care (ESAIC) recommendations. The reported outcome is the percentage of participants achieving a KPA-Score of at least 60%.

Time frame
Baseline

Secondary outcomes

1

Self-perceived knowledge of hemostatic agent selection

Participants' self-perceived knowledge regarding hemostatic agent selection, assessed using a 5-point Likert scale (1 = very low knowledge; 5 = very high knowledge).

Time frame
Baseline
2

Knowledge-Practice Alignment Score (KPA-Score)

Percentage of guideline-concordant responses across five standardized clinical vignettes assessing hemostatic agent selection. Scores range from 0% to 100%, with higher scores indicating greater concordance with current European Association for Cardio-Thoracic Surgery (EACTS) and European Society of Anaesthesiology and Intensive Care (ESAIC) recommendations.

Time frame
Baseline
3

Correlation between self-perceived knowledge and Knowledge-Practice Alignment Score

Correlation between participants' self-perceived knowledge (5-point Likert scale) and their Knowledge-Practice Alignment Score (0%-100%), assessed using Spearman's rank correlation coefficient (ρ).

Time frame
Baseline
4

Concordance between declared and actual hemostatic agent use

Agreement between participants' self-reported patterns of hemostatic agent use and institutional pharmacy dispensing data during the 12 months preceding survey administration, assessed using Cohen's kappa coefficient (κ).

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Milan

Lead sponsor

Source ClinicalTrials.gov
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