Protocol Adherence When Managing Massive Bleeding Following Complex Cardiac Surgery: A Study Design Pilot

ObjectiveHigh-quality prospective trials of hemostatic “rescue” therapy to control massive bleeding in cardiac surgery are lacking. Wide variability in the care of patients with severe bleeding following cardiopulmonary bypass has precluded accurate comparison of treatment groups in previous studies. This study identified the use of a management protocol for early identification and uniform treatment of patients with massive bleeding for application in future trials of hemostatic rescue agents.DesignA prospective, nonblinded, interventional feasibility study.SettingA university teaching hospital.ParticipantsForty-three adult patients undergoing complex cardiac surgery.InterventionsStudy participants undergoing high-risk cardiac surgery received standardized treatment in accordance with a bleeding management protocol.Measurements and Main ResultsTwenty-seven patients (63%) had severe bleeding following heparin reversal and received conventional hemostatic resuscitation per protocol. Six patients had massive refractory bleeding. Compliance with protocol tasks was≥90% in 4 of 5 categories (anticoagulation, hemostasis scoring, recording blood loss, protocol transfusion) with the exception being submission of laboratory samples (76%). Measured bleeding rates (mL/h) following heparin reversal were clearly differentiated in those with hemostasis scores≥3 compared to those with scores≤2 (1,420±957 v 147±96; p<0.001).ConclusionsAdherence to a management protocol for massive bleeding is feasible and allows for homogenous treatment of patients before study arm randomization in future “rescue” therapy trials. The authors’ protocol allowed for prompt and accurate identification of patients with severe bleeding refractory to conventional therapy. This review resolved several key barriers in the design of severe bleeding management trials.