Evaluation of Appropriateness in the Use of Hemostatic Agents in Cardiovascular Surgery: A Mixed-Methods Single-Center Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving a Knowledge-Practice Alignment Score (KPA-Score) ≥60%
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: observational study (Other)
结局指标
主要结局
Proportion of participants achieving a Knowledge-Practice Alignment Score (KPA-Score) ≥60%
时间窗: 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%.
次要结局
- 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)
- Perceived barriers to appropriate hemostatic agent selection(Baseline)
研究者
Luca Galassi
Principal Investigator
University of Milan