Appropriateness of Hemostatic Agent Use in Cardiovascular Surgery (HAEMOVAX) (HAEMOVAX)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Hemostasis; Vascular Surgery; Perioperative Bleeding; Cardiovascular Surgery
• Intervention / Treatment: Other: observational study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Luca Galassi, MD; Phone Number: +393458013083; Email: luca.galassi@unimi.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20157
      • Recruiting
      • IRCCS Galeazzi Sant'Ambrogio Hospital
      • Contact: Luca Galassi, MD; Phone Number: +393458013083; Email: luca.galassi@unimi.it
      • Sub-Investigator: Beatrice Faitelli, PharmD
      • Sub-Investigator: Domenico Bruno Vito, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemostatic agents usage assessment cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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).	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).	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Perioperative Bleeding; Surgical Hemostasis; Hemostatic Agents; Topical Hemostatic Agents
• Additional Relevant MeSH Terms: Investigative Techniques; Methods; Observation
• Other Study ID Numbers: HAEMOVAX-v1.0-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No