Protocol adherence when managing massive bleeding following complex cardiac surgery: a study design pilot.

Area of Science:

• Cardiac Surgery
• Critical Care Medicine
• Hematology

Background:

• High-quality prospective trials for hemostatic rescue therapy in massive bleeding during cardiac surgery are scarce.
• Variability in managing severe bleeding post-cardiopulmonary bypass hinders accurate comparisons in previous studies.

Purpose of the Study:

• To identify a management protocol for early identification and uniform treatment of massive bleeding patients.
• To prepare for future trials of hemostatic rescue agents in cardiac surgery.

Main Methods:

• Prospective, nonblinded, interventional feasibility study at a university teaching hospital.
• Forty-three adult patients undergoing complex cardiac surgery received standardized treatment per a bleeding management protocol.

Main Results:

• Protocol adherence was high (≥90%) in most categories, except laboratory sample submission (76%).
• The protocol differentiated bleeding rates, with scores ≥3 showing significantly higher bleeding (1,420±957 mL/h) versus scores ≤2 (147±96 mL/h; p<0.001).
• Twenty-seven patients (63%) experienced severe bleeding and received conventional resuscitation; six had massive refractory bleeding.

Conclusions:

• Adherence to the massive bleeding management protocol is feasible and ensures homogenous patient treatment for future trials.
• The protocol facilitates prompt identification of patients with severe bleeding refractory to conventional therapy.
• This approach addresses key design barriers in trials for severe bleeding management.