An observational study in Hemostasis, Perioperative Bleeding and Cardiovascular Surgery, sponsored by University of Milan. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by University of Milan · Observational
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.
Hemostatic agents are routinely used in cardiac and vascular surgery to support local bleeding control and facilitate surgical hemostasis. Their use may influence several clinically relevant outcomes, including perioperative blood loss, transfusion requirements, operative time, reintervention for bleeding, and postoperative complications. In addition to their clinical implications, topical hemostatic agents represent a significant component of procedural costs in cardiovascular surgery.
Despite their widespread use, evidence regarding real-world utilization patterns remains limited. Available literature is largely derived from industry-sponsored randomized trials designed to evaluate the efficacy of individual products in selected procedural settings. Consequently, little is known about how hemostatic agents are actually selected and utilized in routine clinical practice, the degree of adherence to contemporary evidence-based recommendations, and the potential discrepancy between clinicians' perceived knowledge and their decision-making in standardized clinical scenarios.
Furthermore, many institutions lack formal protocols governing the selection of hemostatic agents according to surgical indication, bleeding severity, or patient-specific factors. This may contribute to substantial variability in practice patterns, inefficient resource allocation, and inconsistent application of current guideline recommendations. Understanding these factors is essential to support evidence-based standardization strategies and optimize both clinical and economic outcomes.
The HAEMOVAX study is a single-center mixed-methods observational study conducted at IRCCS Galeazzi-Sant'Ambrogio Hospital, Milan, Italy. The study consists of three complementary components: (1) an anonymous structured survey administered to cardiac and vascular surgeons; (2) a retrospective audit of institutional hemostatic agent consumption derived from pharmacy and operating room supply records; and (3) a qualitative thematic analysis of narrative clinical cases reported by participants.
The primary objective is to evaluate the appropriateness of hemostatic agent selection using the Knowledge-Practice Alignment Score (KPA-Score). The KPA-Score is calculated from responses to five standardized clinical vignettes representing common cardiovascular surgical scenarios. Appropriateness is defined as concordance between the participant's selected hemostatic strategy and recommendations derived from contemporary EACTS and ESA guidelines. Individual KPA-Scores range from 0% to 100%, with scores of 60% or greater considered indicative of appropriate hemostatic agent selection.
Secondary objectives include characterization of self-reported utilization patterns of hemostatic agents, assessment of perceived barriers to appropriate use, evaluation of concordance between declared practice and institutional consumption data, estimation of opportunities for evidence-based standardization, and identification of factors associated with lower KPA-Scores. Qualitative analysis will be performed to explore themes not fully captured by structured survey questions, including decision-making processes, institutional barriers, and perceptions regarding product effectiveness and availability.
All attending surgeons, fellows, and residents affiliated with the Cardiac Surgery and Vascular Surgery Units will be eligible to participate. Survey responses will be collected anonymously. Consumption data will be analyzed in aggregated form at the unit level. No patient-identifiable information will be collected or analyzed.
Study findings are expected to provide a comprehensive assessment of the appropriateness of hemostatic agent use within a high-volume cardiovascular surgical center and to identify opportunities for educational interventions, institutional protocol development, resource optimization, and evidence-based standardization of clinical practice.
University of Milan is the lead sponsor of 183 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single cohort including all cardiovascular surgery personnel (cardiac and vascular surgeons, consultants and trainees) at IRCCS Galeazzi-Sant'Ambrogio participating in a cross-sectional survey and linked institutional retrospective audit of hemostatic agent utilization.
Other: observational 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.
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
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
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
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
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
Distribution of hemostatic agent selection across standardized clinical vignettes
Percentage of participants selecting each hemostatic agent category for each of the five standardized clinical vignettes.
Time frame: Baseline
Perceived barriers to appropriate hemostatic agent selection
Percentage of participants reporting each predefined institutional, clinical, or logistical barrier to appropriate hemostatic agent selection, as assessed using the HAEMOVAX structured survey questionnaire.
Time frame: Baseline
Plan to share: No — Individual participant data (IPD) will not be shared, as the study involves an anonymous cross-sectional survey of healthcare professionals and aggregated institutional audit data without patient-level datasets.
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jul 2026, 0 months later.
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