HemostasisHAEMOVAXNCT07699016
Appropriateness of Hemostatic Agent Use in Cardiovascular Surgery (HAEMOVAX)
An observational study of Hemostasis and Perioperative Bleeding, run by University of Milan at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemostasis, Perioperative Bleeding, Cardiovascular Surgery
- What is being tested?
- observational study
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2026to 15 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Galeazzi Sant'Ambrogio Hospital
Milan, MI, 20157
Luca Galassi, MD, +393458013083, luca.galassi@unimi.it
Beatrice Faitelli, PharmD
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemostasis, Perioperative Bleeding, Cardiovascular Surgery, Cardiac Surgery, Vascular Surgery
- Being tested
- observational study
- Keywords
- Hemostatic Agents, Surgical Hemostasis, Topical Hemostatic Agents, Perioperative Bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion16 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Galassi, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699016
- Sponsor's protocol ID
- HAEMOVAX-v1.0-2026
- Acronym
- HAEMOVAX
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Appropriateness in the Use of Hemostatic Agents in Cardiovascular Surgery: A Mixed-Methods Single-Center Observational Study
- ClinicalTrials.gov ID
- NCT07699016
- Acronym / sponsor ID
- HAEMOVAX / HAEMOVAX-v1.0-2026
- Conditions
- Hemostasis, Perioperative Bleeding, Cardiovascular Surgery, Cardiac Surgery, Vascular Surgery
- Keywords
- Hemostatic Agents, Surgical Hemostasis, Topical Hemostatic Agents, Perioperative Bleeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 16 Jul 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemostatic agents usage assessment cohort | – | Other: observational studySingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyCross-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. | Other | Hemostatic agents usage assessment cohort |
Primary outcome
Proportion of participants achieving a Knowledge-Practice Alignment Score (KPA-Score) ≥60%
Time frame: Baseline
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%.
6 secondary outcomes
Self-perceived knowledge of hemostatic agent selection
Time frame: Baseline
Knowledge-Practice Alignment Score (KPA-Score)
Time frame: Baseline
Correlation between self-perceived knowledge and Knowledge-Practice Alignment Score
Time frame: Baseline
Concordance between declared and actual hemostatic agent use
Time frame: baseline
Distribution of hemostatic agent selection across standardized clinical vignettes
Time frame: Baseline
Perceived barriers to appropriate hemostatic agent selection
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemostasis and Perioperative Bleeding, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Galassi, MD (+393458013083, luca.galassi@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving a Knowledge-Practice Alignment Score (KPA-Score) ≥60% (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.