title: Protocol adherence when managing massive bleeding following complex cardiac surgery: a study design pilot.
abstract: OBJECTIVE
  High-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.
  
  
  METHODS
  A prospective, nonblinded, interventional feasibility study.
  
  
  METHODS
  A university teaching hospital.
  
  
  METHODS
  Forty-three adult patients undergoing complex cardiac surgery.
  
  
  METHODS
  Study participants undergoing high-risk cardiac surgery received standardized treatment in accordance with a bleeding management protocol.
  
  
  RESULTS
  Twenty-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).
  
  
  CONCLUSIONS
  Adherence 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.
authors.affiliation: Department of Anesthesiology & Pain Management, University of Texas Southwestern School of Medicine, Dallas, Texas. Electronic address: philip.greilich@utsouthwestern.edu.
authors.forename: Philip E
authors.initials: PE
authors.lastname: Greilich
authors.affiliation: Department of Anesthesiology & Pain Management, University of Texas Southwestern School of Medicine, Dallas, Texas.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Edson
authors.affiliation: Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Lindsey
authors.initials: L
authors.lastname: Rutland
authors.affiliation: Department of Cardiovascular & Thoracic Surgery, University of Texas Southwestern School of Medicine, Dallas, Texas.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Jessen
authors.affiliation: Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
authors.forename: Nigel S
authors.initials: NS
authors.lastname: Key
authors.affiliation: Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Jerrold H
authors.initials: JH
authors.lastname: Levy
authors.affiliation: Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Nauder
authors.initials: N
authors.lastname: Faraday
authors.affiliation: Pediatric Hematology/Oncology and Pediatric Critical Care, University of Minnesota School of Medicine, Minneapolis, Minnesota.
authors.forename: Marie E
authors.initials: ME
authors.lastname: Steiner
mesh_terms: D000925:Anticoagulants / Q000627:therapeutic use*; D001777:Blood Coagulation; D016063:Blood Loss, Surgical / Q000706:statistics & numerical data*; D001803:Blood Transfusion / Q000706:statistics & numerical data*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D005240:Feasibility Studies; D005260:Female; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies
chemical_list: D000925:Anticoagulants; D006493:Heparin
keywords: cardiac surgery; cardiopulmonary bypass; coagulation; hemorrhage; transfusion