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.
RCT Entities:
OBJECTIVES: The effect of treatment guidelines on clinical outcomes in general and specifically for traumapatients 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 traumapatients 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 traumapatients, higher compliance with guidelines for damage control, transfusion, and ventilation management is associated with lower mortality and improved outcomes.
Authors: Kinjal N Sethuraman; Evie G Marcolini; Maureen McCunn; Bhakti Hansoti; Federico E Vaca; Lena M Napolitano Journal: Acad Emerg Med Date: 2014-11-24 Impact factor: 3.451
Authors: Robert Russell; David F Bauer; Susan M Goobie; Thorsten Haas; Marianne E Nellis; Daniel K Nishijima; Adam M Vogel; Jacques Lacroix Journal: Pediatr Crit Care Med Date: 2022-01-01 Impact factor: 3.624
Authors: Angela Sauaia; Ernest E Moore; Jeffrey L Johnson; Theresa L Chin; Anirban Banerjee; Jason L Sperry; Ronald V Maier; C Cothren Burlew Journal: J Trauma Acute Care Surg Date: 2014-03 Impact factor: 3.313
Authors: V Albrecht; N Schäfer; E K Stürmer; A Driessen; L Betsche; M Schenk; M Maegele Journal: Eur J Trauma Emerg Surg Date: 2015-11-30 Impact factor: 3.693
Authors: Allan Doctor; Jill M Cholette; Kenneth E Remy; Andrew Argent; Jeffrey L Carson; Stacey L Valentine; Scot T Bateman; Jacques Lacroix Journal: Pediatr Crit Care Med Date: 2018-09 Impact factor: 3.624
Authors: Rolf Rossaint; Bertil Bouillon; Vladimir Cerny; Timothy J Coats; Jacques Duranteau; Enrique Fernández-Mondéjar; Daniela Filipescu; Beverley J Hunt; Radko Komadina; Giuseppe Nardi; Edmund A M Neugebauer; Yves Ozier; Louis Riddez; Arthur Schultz; Jean-Louis Vincent; Donat R Spahn Journal: Crit Care Date: 2016-04-12 Impact factor: 9.097