Consensus Statement: Hemostasis Trial Outcomes in Cardiac Surgery and Mechanical Support

Area of Science:

• Cardiovascular Surgery
• Biomedical Engineering
• Clinical Trial Design

Background:

• Clinical trials for hemostatic agents lack standardized primary outcomes, hindering research comparability.
• Inconsistent outcomes affect studies in cardiac surgery and mechanical circulatory support (MCS).
• Examples of MCS include extracorporeal membrane oxygenation (ECMO) and ventricular assist devices (VADs).

Purpose of the Study:

• To develop consensus recommendations for primary outcomes in cardiac surgery and MCS clinical trials.
• To address the inconsistency and lack of standardization in evaluating hemostatic agents.
• To improve the design and comparability of future research in these critical areas.

Main Methods:

• A subgroup of experts convened by the National Heart, Lung, and Blood Institute and the US Department of Defense.
• Development of consensus recommendations for primary clinical trial outcomes.
• Focus on cardiac surgery and mechanical circulatory support.

Main Results:

• For cardiac surgery, recommended primary efficacy endpoint is total allogeneic blood products administered through day 5 or hospital discharge.
• For ECMO, recommended primary outcome is a 5-point ordinal score of thrombosis and bleeding severity.
• For VADs, recommended primary endpoint is freedom from disabling stroke through day 180.

Conclusions:

• Proposed composite risk scores can impact future clinical trial design and enable comparability.
• Harmonizing global consensus definitions and management guidelines can reduce patient heterogeneity.
• Standardized outcomes are crucial for advancing research on hemostatic agents and patient care.