Objectives: The effect of treatment guidelines on clinical outcomes in general and specifically for trauma patients has not been well-studied. We hypothesized that better compliance with guidelines would be associated with improved clinical outcomes.
Design: Prospective, randomized, double-blinded, multicentered, placebo-controlled study of recombinant factor VII in severe trauma that utilized guidelines for damage control, transfusions, and mechanical ventilation. Vanderbilt Coordinating Center reviewed compliance in near real-time and reported deviations classified as minor, moderate, or major to investigators. Multivariate regression analysis measured the association between outcomes (30-day and 90-day mortality, development of multiple organ failure, ventilator-free days, renal failure-free days, and blood products transfused) and compliance with each guideline, as well as a composite assessment of overall compliance.
Setting: One hundred hospitals in 26 countries.
Patients: Blunt and/or penetrating trauma patients aged 18–70 yrs who had received 4–8 units of red blood cells for active torso and/or proximal lower extremity bleeding despite standard interventions.
Measurements and Main Results: When assessed as composite end point, major deviations from guidelines were associated with significantly higher mortality at 30 and 90 days after injury and fewer renal failure-free days. Moderate deviations were associated with a significantly higher risk of multiple organ failure and fewer ventilator-free days. Moderate and major deviations from damage control and ventilation guidelines were also significantly associated with higher risk of death at days 30 and 90. Within the ventilation protocol, noncompliance with tidal volume and plateau pressure targets was associated with significantly higher mortality at days 30 and 90 and fewer ventilator-free days, whereas noncompliance with weaning guideline was only associated with significantly fewer ventilator-free days.
Conclusions: In a clinical trial of trauma patients, higher compliance with guidelines for damage control, transfusion, and ventilation management is associated with lower mortality and improved outcomes.
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From the Vanderbilt University Medical Center (TWR, APW), Nashville, TN; UCLH/UCL Comprehensive Biomedical Research Centre (SM), UCL Division of Research Strategy, UCL Research Department of Epidemiology and Public Health, UCL, London, UK; Novo Nordisk (BJT) Princeton, NJ; Regulatory Affairs (MCC), Novo Nordisk A/S, Søborg, Denmark.
* See also p. 990.
Supported, in part, by Novo Nordisk A/S.
Dr. Rice has received consulting fees from Novo Nordisk regarding the conduct of the recombinant activated factor VII trauma trial. Dr. Christensen is employed by and holds stock ownership with Novo Nordisk, Inc. Dr. Morris received consultancy fees from Novo Nordisk, Inc. Dr. Tortella was formally employed by Novo Nordisk, Inc. The remaining authors have not disclosed any potential conflicts of interest.
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