Appropriateness of Hemostatic Agent Use in Cardiovascular Surgery (HAEMOVAX)

NCT07699016 | Recruiting

• 1 other identifier: HAEMOVAX-v1.0-2026
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemostasis; Perioperative Bleeding; Cardiovascular Surgery; Cardiac Surgery; Vascular Surgery

Keywords

Hemostatic Agents; Surgical Hemostasis; Topical Hemostatic Agents; Perioperative Bleeding

Outcome Measures

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%.

  Baseline

Secondary Outcomes (6)

• Self-perceived knowledge of hemostatic agent selection

  Baseline

• Knowledge-Practice Alignment Score (KPA-Score)

  Baseline

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

  Baseline

• Concordance between declared and actual hemostatic agent use

  baseline

• Distribution of hemostatic agent selection across standardized clinical vignettes

  Baseline

Study Arms (1)

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

Interventions

observational study OTHER

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.

Hemostatic agents usage assessment cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

IRCCS Galeazzi Sant'Ambrogio Hospital

Milan, MI, 20157, Italy

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Luca Galassi, MD

CONTACT

+393458013083; luca.galassi@unimi.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion: July 16, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)