What’s New in Trauma and Critical Care Chet A Morrison, MD, FACS, FCCM Attending Trauma Surgeon Lancaster General Hospital

What’s New in Trauma and Critical Care

Chet A Morrison, MD, FACS, FCCM

Attending Trauma Surgeon

Lancaster General Hospital

Traumatic Injury: Still the Same Old Problem

•From 2000 to 2010, the US population increased by 9.7% and the number of trauma deaths increased by 22.8%.

•Trauma deaths and death rates deceased in individuals younger than 25 years but increased for those 25 years and older.

•The largest increases in trauma deaths were in individuals in their fifth and sixth decades of life. Since 2000, the largest proportional increase (118%) in crude trauma deaths occurred in 54-year-olds.

•Overall, in 2010, trauma was the leading cause of death in individuals 46 years and younger. Trauma remains the leading cause of years of life lost

Rhee P et al Ann Surg 2014, 260(1): 13-21

Plus ca change….

Maybe This is Why

Gunshot Wounds: Unrelenting Violence

Ten Year Retrospective Look at GSW victims

6322 patients

Increase in number of gunshots per patients and body cavity wounds

Increase in Mortality

Total Inpatient cost 115 Million

75% unreimbursed

Livingston D et al J Trauma Acute Care Surg 2014 76(1): 2-11

Gunshot Wounds: Unrelenting Violence

Livingston D et al J Trauma Acute Care Surg 2014 76(1): 2-11

Hemostatic Resuscitation: The Prospective, Observational, Multicenter, Major Trauma Transfusion (PROMMTT) Study

Holcomb JB Arch Surg. Published online October 15, 2012.doi:10.1001/2013.jamasurg.387

•Objective: To relate in-hospital mortality to early transfusion of plasma and/or platelets and to time-varying plasma:red blood cell (RBC) and platelet:RBC ratios.

•Prospective cohort study documenting the timing of transfusions during active resuscitation and patient outcomes. Data were analyzed using time dependent proportional hazards models.



• Setting: Ten US level I trauma centers.

•Patients: Adult trauma patients surviving for 30 minutes after admission who received a transfusion of at least 1 unit of RBCs within 6 hours of admission (n=1245, the original study group) and at least 3 total units (of RBCs, plasma, or platelets) within 24 hours (n=905, the analysis group).

•Main Outcome Measure: In-hospital mortality.



•Results: Plasma:RBC and platelet:RBC ratios were not constant during the first 24 hours (P.001 for both).

• In a multivariable time-dependent Cox model, increased ratios of plasma:RBCs (adjusted hazard ratio=0.31; 95% CI, 0.16-0.58) and platelets:RBCs (adjusted hazard ratio=0.55; 95% CI, 0.31-0.98) were independently associated with decreased 6-hour mortality, when hemorrhagic death predominated. In the first 6 hours, patients with ratios less than 1:2 were 3 to 4 times more likely to die than patients with ratios of 1:1 or higher.

•After 24 hours, plasma and platelet ratios were unassociated with mortality, when competing risks from nonhemorrhagic causes prevailed.



•Conclusions: Higher plasma and platelet ratios early in

resuscitation were associated with decreased mortality

in patients who received transfusions of at least 3 units

of blood products during the first 24 hours after admission.

Among survivors at 24 hours, the subsequent risk

of death by day 30 was not associated with either ratio

Non constant ratios make this a confusing question!






PROPPR: Pragmatic Randomized Optimal Platelet and Plasma Ratios

• ObjectiveThis trial is sponsored by the National Heart Lung and Blood Institute and others. PROPPR is a multicenter, randomized trial which will compare different ratios of blood products given to trauma patients who are predicted to require massive transfusions (greater than 10 units of PRBCs within the first 24 hours). The patients who have been predicted to require a massive transfusion will receive blood products based on a 1:1:1 or 1:1:2 ratio of platelets, plasma and red blood cells. A total of 680 patients were enrolled into this study from 12 participating sites in the United States and Canada. In addition to evaluating the patient outcomes based on ratio of products, extensive lab analysis will be done to evaluate the influence of fluid resuscitation on traumatic induced coagulopathy. The PROPPR trial will be conduced under exception from informed consent. The trial began in August of 2012 and concluded enrollment on December 2, 2013. Data analysis is currently underway.

http://clinicaltrials.gov/ct2/show/NCT01545232

A Paradigm Shift in Trauma Resuscitation: Evaluation of Evolving Massive Transfusion Practices

• Objective To evaluate changes in the administration of fluids and blood products, hypothesizing that a reduction in crystalloid volume and a reduced red blood cell (RBC) to fresh frozen plasma (FFP) ratio over the last 7 years would correlate with better resuscitation outcomes.

• Design Observational prospective cohort study.

• Setting Urban level I trauma center.

• Participants A total of 174 trauma patients receiving a massive transfusion (>10 units of RBCs in 24 hours) or requiring the activation of the institutional massive transfusion protocol from February 2005 to June 2011.

Kutcher ME JAMA Surg. 2013;148(9):834-840.


A, The mean combined numbers of red blood cells (RBCs), fresh frozen plasma (FFP), and pooled donor platelets given within 24 hours of admission, by year of study period, are shown. The bars represent the product breakdown (P = .03 by test for trend).

TimeB, The median ratios of RBCs to FFP transfused within 24 hours of admission, by year of study period (P = .20 by test for trend), are shown.

C, The median volumes of intravenous crystalloid administered within 24 hours of admission, by year of study period (P < .001 by test for trend),




Kaplan-Meier 72-hour survival plots based on the red blood cell (RBC) to fresh frozen plasma (FFP) ratio transfused within 24 hours of admission are shown for unadjusted survival (P < .001 determined by log-rank test) (A) and adjusted for age, Injury Severity Score, Glasgow Coma Scale score, and base deficit at admission using Cox proportional hazards regression (B).

TEG

•Originally used in Cardiopulmonary bypass

•May predict who will require transfusion

•Platelet mapping may be useful

•May decrease blood product use

•May predict pulmonary embolism risk

TEG

Cotton, B J Trauma Acute Care Surg. 2012 72(6):1470-1477

TXA

•Generic relatively cheap fibrinolysis inhibitor

•Demonstrated ‘efficacy’ in CRASH-2

•Easy to administer

•Issues with study

•No benefit 3 hrs after injury

TXA

Valle EJ J Trauma Acute Care Surg 2014 76(1): 1373

Date of download: 7/16/2014Copyright © 2014 American Medical

Association. All rights reserved.

From: Declining Case Fatality Rates for Severe Sepsis: Good Data Bring Good News With Ambiguous Implications

JAMA. 2014;311(13):1295-1297. doi:10.1001/jama.2014.2639

Potential Mechanisms of Decreasing Short-term Mortality Among Patients Across a Distribution of Illness Severity

Figure Legend:

Sepsis Care: The ProCESS TrialBackgound

•In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care.

• Trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary.

The ProCESS Investigators. N Engl J Med 2014;370:1683-1693

Sepsis Care: The ProCESS TrialMethod

•In 31 emergency departments in the United States, patients with septic shock were randomly assigned to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care.

•The primary end point was 60-day in-hospital mortality; sequentially evaluation whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support.



Sepsis Care: The ProCESS Trial

Sepsis Care: The ProCESS TrialResults

•1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care.• •Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions.

•By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support.


Sepsis Care: The ProCESS TrialConclusion

•The investigators concluded that in a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. ProCESS ClinicalTrials.gov number, NCT00510835.)


http://clinicaltrials.gov/show/NCT00510835

Outcomes.

The ProCESS Investigators. N Engl J Med 2014;370:1683-1693.

Sepsis Care: The ProCESS TrialRESULTS

Cumulative Mortality.

The ProCESS Investigators. N Engl J Med 2014;370:1683-1693.

Sepsis Care: The ProCESS TrialSurvival

Other Recent Attempts at Sepsis Therapy

•HFOV

-Found to be ineffective at one trial; increased mortality in another

• Statins

-Also not effective; no significant mortality decreases

•CytoFab

-CytoFab, a polyclonal anti–tumor necrosis factor antibody (ClinicalTrials.gov number, NCT01145560)

Work halted, proposed trial canceled

Prone Positioning in Severe ARDS

Guerin et Al NEJM 2013 www.NEJM.org

Cognitive Impairment as a Long Term Problem(Whisker Plot)

Cognitive Impairment as a Function of Delirium Duration

Nutritional Interventions for Critically Ill Patients, According to Data from Randomized, ControlledENteralTrials.

Casaer MP, Van den Berghe G. N Engl J Med 2014;370:1227-1236.

Enteral Feeding Summary

Comparison of Macronutrient Intake and Outcomes of Five Randomized, Controlled Trials Evaluating Nutrition during Critical Illness

Pragmatic, open, multicenter, parallel-group, randomized, controlled trial; 33 ICU in England participated

Patients who were at least 18 years of age were eligible if they were expected to require nutritional support for at least 2 days, as determined by a clinician within 36 hours after an unplanned ICU admission that was expected to last at least 3 days.

Could be fed either way

Trial of the Route of Early Nutritional Support in Critically Ill Adults

Harvey SE et al. N Engl J Med 2014;371:1673-1684

Daily SOFA Score and Protein and Caloric Intake from Days 1 to 6.

Harvey SE et al. N Engl J Med 2014;371:1673-1684.

Daily SOFA Score and Protein and Caloric Intake from Days 1 to 6.

Harvey SE et al. N Engl J Med 2014;371:1673-1684.

The target nutritional value of 25 kcal per kilogram per day was NOT achieved for the majority of patients in the two study groups, although caloric intake was similar in the two groups.

Rice TW et al JAMA 2012;307:795-803

•Designed to answer the question of trophic vs Full Feeds in ALI

•Randomized, open-label,multicenter trial conducted from January 2, 2008, through April 12, 2011.

•1000 adults within 48 hours of developing acute lung injury requiring mechanical ventilation whose physicians intended to start enteral nutrition at 44 hospitals in the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network.

•Participants were randomized to receive either trophic or full enteral feeding for the first 6 days. After day 6, the care of all patients who were still receiving mechanical ventilation was managed according to the full feeding protocol.

•Main Outcome Measures Ventilator-free days to study day 28.

Nutrition: The EDEN trial

Rice TW et al JAMA 2012;307:795-803

• Initial trophic feeding did not increase the number of ventilator-free days (14.9 [95% CI,13.9 to 15.8] vs 15.0 [95% CI, 14.1 to 15.9]; difference, −0.1 [95% CI, −1.4 to 1.2];P=.89)

• 60-day mortality 23.2% vs 22.2% [95% P=.77) compared with full feeding.

•No differences in infectious complications between the groups.

•Despite receiving more prokinetic agents, the full-feeding group experienced more vomiting (2.2% vs 1.7% of patient feeding days; P=.05), elevated gastric residual volumes (4.9% vs 2.2% of feeding days; P.001), and constipation (3.1% vs 2.1%of feeding days; P=.003).

•Meanplasma glucose values and average hourly insulin administration were both higher in the full-feeding group over the first 6 days.

The EDEN trial: Results




Recommendations for Clinical Nutritional Practice in the ICU and for Future Research.

Casaer MP, Van den Berghe G. N Engl J Med 2014;370:1227-1236.

Recommendations

ICP Monitoring: On Trial

• Intracranial-pressure monitoring is considered the standard of care for severe traumatic brain injury. Efficacy of treatment based on monitoring in improving the outcome has not been rigorously assessed.

• Multicenter, controlled trial in which 324 patients 13 years of age or older randomly assigned to one of two specific protocols: guidelines-based management in which a protocol for monitoring intraparenchymal intracranial pressure was used or a protocol in which treatment was based on imaging and clinical examination.

• The primary outcome was a composite of survival time,impaired consciousness, and functional status at 3 months and 6 months and neuropsychological status at 6 months;

Chesnut RA N Engl J Med 2012; 367:2471-2481

ICP Monitoring: On Trial

• There was no significant between-group difference in the primary outcome, a composite measure based on percentile performance across 21 measures of functional and cognitive status (score, 56 in the pressure-monitoring group vs. 53 in the imaging–clinical examination group; P = 0.49).

• Six-month mortality was 39% in the pressure-monitoring group and 41% in the imaging–clinical examination group

• The median length of stay in the ICU was similar in the two groups (12 days in the pressure-monitoring group and 9 days in the imaging–clinical examination group; P = 0.25)

• The number of days of brain-specific treatments (e.g.administration of hyperosmolar fluids and the use of hyperventilation) in the ICU was higher in the imaging–clinical examination group than in the pressure-monitoring group (4.8 vs. 3.4, P = 0.002).

• The distribution of serious adverse events was similar in the two groups.

Chesnut RA N Engl J Med 2012; 367:2471-2481

ICP Monitoring: On TrialConclusions

•For patients with severe traumatic brain injury, care focused on maintaining monitored intracranial pressure at 20 mm Hg or less was not shown to be superior to care based on imaging and clinical examination

•So wither ICP monitors?

•Still part of BTF recommendations

CDC New Definition VAE

•Multiple Stakeholders (none of them surgeons)

•Tiered System

•Variety of Clinical, radiologic and microbiologic criteria

•Concerns raised about under/overdiagnosis and ‘gaming

New CDC Definition of VAP



How We are Denied Money

Rib Fractures

Rib Fracture Fixation: Prospective Trial

•Traumatic flail chest injury

•A prospective randomized study compared operative fixation of fractured ribs in the flail segment with current best practice mechanical ventilator management. In-hospital data, 3-month follow-up review, spirometry and CT, and 6-month quality of life (Short Form-36) questionnaire were collected.

•Patients in the operative fixation group had significantly shorter ICU stay (hours) postrandomization (285 hours [range 191 to 319 hours] for the surgical group vs 359 hours [range 270 to 581 hours] for the conservative group; p = 0.03) and lesser requirement for noninvasive ventilation after extubation (3 hours [range 0 to 25 hours] in the surgical group vs 50 hours [range 17 to 102 hours] in the conservative group; p = 0.01). No differences in spirometry at 3 months or quality of life at 6 months were noted.

•Operative fixation of fractured ribs reduces ventilation requirement and intensive care stay in a cohort of multitrauma patients with severe flail chest injury.

Marasco S J AM Coll Surg 216 (5) 2013





RIB Fracture Fixation: Cost Analysis Costs of Procedures and Diagnoses Based on 2010 National Medicare Reimbursement

Procedure/diagnosis Cost, $

ORIF 3,961.16

Flail chest 484.02

Wound infection 4,894.69

Sepsis 5,627.73

Bleeding 4,894.69

DVT 3,281.29

PE 5,390.61

Intubation<96 h 11,279.68

Intubation>96 h 26,123.17

Tracheostomy with intubation <96 h 11,661.63

Tracheostomy with intubation>96 h 26,505.12

VAP 3,679.84

Bhatnagar A - J Am Coll Surg - 01-AUG-2012; 215(2): 201-5

RIB Fracture Fixation: Cost Analysis

•

Mean cost effectiveness of open reduction and internal fixation for flail chest (ORIF-FC) vs standard of care (SOC).

Bhatnagar A - J Am Coll Surg - 01-AUG-2012; 215(2): 201-5

Killing a Patient to Save His Life

The Future: Suspended Animation

The Future: Suspended Animation

Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT)

• Systematic preclinical studies at the Safar Center for Resuscitation Research under the direction of Drs. Safar, Sam Tisherman, and Pat Kochanek demonstrated the feasibility of inducing profound hypothermia (50ºF or 10ºC) to provide a prolonged period of cardiac arrest after exsanguinating hemorrhage.

• Dr. Tisherman is now leading the Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT) Study. This study is a feasibility and safety study designed to see if hypothermia is beneficial in this setting. In EPR, body temperature is lowered to about 50ºF (10ºC) by administering a large volume of cold fluid through a cannula placed into the aorta. A heart-lung bypass machine would be used to restore blood circulation and oxygenation as part of the resuscitation process. The study will be conducted at the University of Pittsburgh and the University of Maryland.

• Estimated Completion by Dec 2016

Under Fire: Gun Violence is not just an Urban Problem

• C. Morrison1, K. Bupp1, B. Gross1, K. Rittenhouse1, F. Rogers1 ; 1Lancaster General Hospital, Trauma, Lancaster, PA, USA

•Introduction: Gun violence continues to be a source of trauma patient morbidity and mortality annually in U.S. communities. Recent research suggests increasing gunshot violence severity in urban centers. We sought to characterize gun violence in the combined suburban and rural county of Lancaster, PA, to compare it to gun violence results obtained in urban areas.


Methods: In a Pennsylvania-verified, level II trauma center, treated gunshot wounds (GSW) from January 2000 to December 2013 were queried from the trauma registry. BB/pellet GSWs were excluded. Data collected included mortality, ISS, and number of GSW per patient. Cost data was obtained for patients from 2004-2013, and costs were calculated using cost-charge modifiers. A binary logistic regression was performed to assess mortality over time. Linear trend tests assessed the change in percent of patients with 3 or more GSWs, with ISS≥15 and ISS≥25 over the 14-year study period. Significance was defined as p<0.05.


Results: A total of 478 patients met inclusion criteria. Of these patients, 83.3% sustained interpersonally-inflicted GSWs, while the remaining 16.7% sustained self-inflicted GSWs. The population was 62% white, 35% black, and 3% other.

Risk-adjusted mortality (for age, ISS) showed no significant change in mortality over time (p=0.999).

Linear trend tests revealed no significant changes in percent of patients with 3 or more GSWs (p=0.693), with ISS≥15 (p=0.546), or with ISS≥25 (p=0.342) over time.

No significant change in cost per case was found (p=0.380), however percent reimbursement significantly increased (p=0.009).


Conclusion: Even the fairly suburban and rural communities of Lancaster County, PA are not sheltered from the problem of gun violence, although the rate seems to be stable in a non-urban environment.

Despite advances in pre-hospital and hospital care, including damage control techniques, the mortality from GSW has not changed.

Future efforts to improve the outcome for GSW Must primarily include preventative efforts.

71

Summary Thoughts: Where are we at?

•Trauma Still qualifies as an unrelenting problem

•Liberal use of blood and factors in resuscitation

•We continue with a long list of sepsis interventions that are of limited use

•There are opportunities to improve quality of life in the Critical Patient

Thank You for Your Attention

Documents

What’s New in Trauma and Critical Care Chet A Morrison, MD, FACS, FCCM Attending Trauma Surgeon Lancaster General Hospital