CONTROVERSIES IN TRAUMA
| CENTRAL NERVOUS SYSTEM TRAUMA: SHOULD WE ALWAYS USE STEROIDS ?—Michael T. Fitch, MD,
PhD, Assistant Professor, Department of Emergency Medicine, Wake Forest University, School of Medicine, Winston-
Salem, NC
|
| Rationale behind high-dose steroids: therapy not helpful for initial injury to glial cells and neurons; secondary therapies
based on secondary reaction to injury; brain and spinal cord do not tolerate inflammation well; inflammatory process involves
free radicals, lipid peroxidation, and production of inhibitory molecules, creating environment not supportive of
tissue repair and potential chemical barrier to tissue regrowth, regeneration, and repair; cellular substrate gone in some
cases; cavities develop weeks after injury (inhibitory to healing process); intense inflammatory reaction after traumatic
injury extends to areas not directly injured (target this process with therapy); steroids’ ability to modify inflammation
leads to theory that steroid use in trauma potentially helpful to central nervous system (CNS); animal data—
methylprednisolone potentially efficacious; therapy started at time of injury
|
| Studies: National Acute Spinal Cord Injury Study I (NASCIS I; 1984)—no true placebo group; 2 different doses of
steroids used to look at whether higher dose better than lower dose; no clinical difference found
|
 | NASCIS II (1990): multicenter prospective randomized double-bind trial comparing high-dose methylprednisolone to
naloxone (Narcan) or placebo; 95% of patients had 1-yr follow-up; majority of patients enrolled within 12 hr of injury;
primary end point defined as change in neurologic examination; neurologic examinations consisted of motor
strength and pinprick and touch sensations performed at baseline, 6 wk, 6 mo, and 1 yr; results—at 6 wk, no significant
difference in any parameter; at 6 mo, no significant difference in motor function but slight significant increases
in pinprick and touch sensations; subgroup analysis—patients who received steroids within 8 hr (<40% of
patients in study); at 6 wk, slight statistically significant increases in motor function and touch, but not in pinprick;
at 6 mo, statistically significant increase in motor function (5-point increase), pinprick, and touch in steroid group;
no significant differences found in patients receiving steroids at >8 hr; conclusion that beneficial effect limited to
those treated within 8 hr; reaction to results—news releases about unpublished data exaggerated implications of
results; National Institutes of Health (NIH) distributed protocol for steroid use to all emergency departments (EDs)
in United States so they could implement immediately; when data released 6 mo later, scientific community concluded
that initial enthusiasm of popular press not matched by strength of data
|
| NASCIS II updated (1991): 1-yr data from study; no significant differences in patient populations; slight increases in
pinprick and touch seen at 6 mo gone by 1 yr; subgroup analysis (steroid at ≤8 hr) showed only 5-point increase in
motor strength (on scale of 70 points); complications in 1-yr group include twice risk for urinary tract infection
(UTI) in steroid group and increased risk for gastrointestinal (GI) bleeding (not statistically significant)
|
| NASCIS III (1997): multicenter trial; no placebo group; high-dose methylprednisolone for 24 hr vs high-dose methylprednisolone
for 48 hr vs tirilazad for 48 hr; 92% follow-up rate; patients received therapy within 8 hr; examination of
motor strength, pinprick and touch sensations, and functional score; found no significant difference in overall patient
group by 1 yr; subgroup analysis of patients receiving steroids in 3 to 8 hr showed statistically significant difference in
motor strength at 6 mo (this difference not present at 1 yr); interpretation that patients who got steroid within 3 hr of
injury should get steroids for 24 hr, those who got steroid 3 to 8 hr after injury should get steroids for 48 hr, and no increased
benefit from tirilazad; statistically significant increase in UTI in 48-hr steroid group
|
| Other studies: Japanese study (1994)—placebo vs steroid; no significant difference in primary outcomes; subgroup
analysis showed sensory but no motor improvements with steroids; retrospective studies—showed no difference in
neurologic status or functional independence scores in patients receiving or not receiving steroids
|
| Controversy: overall, NASCIS studies negative by primary end point; only positive results came from subgroup analysis;
unclear etiology of 8-hr cutoff (authors say 8 hr represented median time at which patient had received or not received
steroids); only 40% of trial patients in subgroup analysis; paper (2000) pointed out that group that got placebo >8
hr after injury did worse than those who got placebo <8 hr after injury; question of why motor score only parameter
with statistical significance at 1 yr and functional relevance of this; no placebo group in NASCIS III trial (point of criticism);
functional independence scores do not correlate with 5-point increase in motor score, leading to question of clinical
significance; meaning of increase in motor score—recovery of 5 motor points potentially equivalent to recovery
of one spinal level; could be clinically relevant or not, depending on level; scoring system potentially fundamentally
flawed (5 points could mean up one spinal level or 1-point increase in different distal muscles adding up to 5 points, statistically
but not clinically significant for overall function); NASCIS III (only study that looked at function) did not
have placebo group and did not find differences in function
|
| Harmful side effects: high-dose steroids not benign treatment; small study showed evidence of steroid-induced myopathy;
small prospective study showed higher incidence of pulmonary and GI complications; NASCIS I found higher incidence
of wound infection in those on high-dose methylprednisolone; NASCIS III found higher incidence of UTI and
pneumonia in those given 48 hr of methylprednisolone
|
| Places using steroids: European Cervical Spine Research Society—survey; majority said they used steroids or should
use steroids; majority also did not entirely believe evidence supports use; Colorado—when medical directors of
trauma centers and emergency medical services (EMS) surveyed, 98% reported using steroids for spinal cord injury,
but 50% uncertain or did not believe data supported use; data from 1996 showed only 65% of patients got steroids per
guidelines in Colorado (practice not following recommendations); North American Spine Society—survey showed
majority used steroids mainly in fear of litigation if steroids not used; 24% believe it improves recovery; rest of those
surveyed used because of hospital protocol; Canadian Spine Surgeons—66% survey response; 25% do not use steroids;
remainder of surgeons surveyed use steroids because of peer pressure (35%) or fear of litigation (35%)
|
| Steroid use in practice: prospective audit—100 patients in spinal cord unit in England; 25% received steroids by protocol;
10% of patients given steroids incorrectly; remainder did not get steroids at all; review—spinal cord injury patients
in South Carolina (1993-2000); 50% of patients received steroids; study from Ireland—28 of 196 patients
given steroids; only 6 received steroids according to NASCIS III protocol; practice suggests majority of patients with
spinal cord injuries not getting steroids
|
| Head injury: steroids used in patients with brain injury for >30 yr; posttraumatic inflammatory changes thought harmful;
review (1997)—included all randomized trials done up to that date; data inconclusive as to risk or benefit; Cortico-
steroid Randomization After Significant Head Injury (CRASH) trial (1990-2004)—prospective multicenter
randomized double-blind placebo-controlled trial of adults with clinically significant head injury, Glasgow Coma
Scale (GCS) ≤14; 10,000 patients enrolled; 48 hr of methylprednisolone vs placebo; primary outcome death within 2
wk or disability at 6 mo; 99% follow-up; mortality at 2 wk 21% in steroid group vs 18% in placebo group, ie, relative
risk for mortality 1.18; mortality increased with steroids; based on this study, recommendation that steroids not be
used in head injury; mechanism of worsened outcome unclear (no obvious increase in infections or GI bleeding); trial
investigators felt use of steroids in spinal cord injury should remain area of debate (spinal cord trials small, compared
to this study, and emphasis from those focused on subgroup effects)
|
| Standard of care: steroids not standard of care in head injury; literature still says steroid use for spinal cord injury
“standard of care”; many people do not support use of methylprednisolone and think studies do not support making it
standard of care; no Food and Drug Administration (FDA) indication or guidelines from American Association of
Neurological Surgeons (AANS); legal definition of standard of care (Black’s Law Dictionary)—“degree of care
which a reasonably prudent physician should exercise under same or similar circumstances”; to prove professional
negligence—must have duty to provide care, breach of care standard, and damage or injury from action or inaction;
historically, have allowed for geographic variation (communities decide standard of care), but with standardization of
medical education, many cases no longer based on local standard of care, but national or specialty standards; standard
of care not equivalent to “majority”; according to concept of “respectable minority,” when given treatment deemed acceptable
by reputable or respected minority of colleagues, it may be accepted as standard of care if controversy exists
as to treatment; establishing standard of care in court—expert witness testimony; literature; published medical
guidelines (often used as evidence)
|
| Published guidelines for methylprednisolone and spinal cord injury: National Association of EMS Physicians—
evidence for use of high-dose steroids for spinal cord injury remains inconclusive and not standard of care for out-of-
hospital emergency medical care; Canadian Spine Society and Canadian Neurosurgical Society—“there is insufficient
evidence to support the use of high-dose methylprednisolone within eight hours following an acute closed spinal
cord injury as a treatment standard or as a guideline for treatment”; “treatment option for which there is weak clinical evidence”;
AANS and Congress of Neurological Surgeons (Guidelines for the Management of Acute Cervical Spine
and Spinal Cord Injuries)—insufficient evidence to support as treatment standard or treatment guideline; treatment
with methylprednisolone for 24 or 48 hr recommended as option in treatment of patients with acute spinal cord injuries
(but should be undertaken only with knowledge that evidence suggesting harmful side effects more consistent than any
suggestion of clinical benefit); speaker suggests possibility that specific patient might benefit from this protocol, but data
do not help identify those patients and data not strong enough to support giving to everyone
|
| Cases: head injury—paraplegic with T8 fracture and head injury; data supportive of not using steroids because of head
injury; L3 burst fracture—paraplegic; cauda equina or nerve root injury excluded from NASCIS trials because below
spinal cord; no data to support this type of injury benefits form steroids; C6 fracture and facet dislocation—complete
paralysis; speaker does not know whether this patient could benefit from steroids; multiple injuries—T5 fracture;
question whether patient at increased risk for steroid complications
|
| Conclusion: controversy remains about steroids for spinal cord injuries; published guidelines from professional organizations
provide support for not using this treatment; contraindications for steroid use include head injury; question of
standard of care remains; critical discussion in community important in deciding course of action for physicians in
area
|
| SCREENING FOR BLUNT CARDIAC TRAUMA: SHOULD WE OR SHOULDN’T WE ?—Kenji Inaba, MD, Assistant
Professor of Surgery, Division of Trauma and Surgical Critical Care, Keck School of Medicine at the University of
Southern California, Los Angeles
|
| Controversy: name—cardiac concussion; blunt cardiac trauma; myocardial contusion; in 1992, nomenclature unified as
blunt cardiac injury (BCI); inconsistent definition—>300 publications in last decade but no consistency in description
of injury; reported incidence varies from 7% to 71%; wide spectrum of injury from mild contusion to wall to rupture;
clinically benign to catastrophic; no gold standard imaging, laboratory or electrocardiography (ECG) findings;
pathologic diagnosis—each of injuries along spectrum has pathologic diagnosis; useful in patients who have expired,
but not so helpful clinically
|
| Clinical goals: identify clinically significant BCI; define population at risk; find sensitive screening test for clinically
significant injuries
|
| Clinically significant BCI: structural—wall motion abnormalities with depressed cardiac function; septal perforation,
valve damage, and wall rupture (all rare in survivors); conduction abnormality—arrhythmias (atrial fibrillation most
common)
|
| People at risk: symptomatic; associated chest trauma; high-risk mechanism; well validated screening criteria do not exist;
rely on associated chest trauma and mechanism to guide screening (sensitive, but not specific for BCI)
|
| Screening: Eastern Association for the Surgery of Trauma (EAST) guidelines—discharge patient if admission ECG
normal; monitor for 24 to 48 hr if admission ECG abnormal (several case reports show that patients with mechanical
chest trauma have normal admission ECG and die from conduction abnormality); “no single test or combination of
tests has proven consistently reliable in detecting cardiac injury”; troponin I—acute myocardial infarction (MI) literature
describes serum cardiac troponin as sensitive and specific marker of cardiac injury; serum troponin potentially
elevated even in patients without mechanical chest trauma; prospective 30-mo study—asked whether troponin
and ECG can act together synergistically to help diagnose patient at risk for BCI; looked at seriously injured patients
with mechanical chest trauma; did serial ECG and troponin I, looking at 0- and 8-hr times; patients with clinically
significant BCI, ie, hemodynamic abnormalities resulting from cardiac wall motion abnormalities, arrhythmias requiring
treatment, and structural defects detected on trans-thoracic echocardiography; (13% positive for clinically
significant BCI) found cardiac troponin I alone had sensitivity of 73%, and ECG alone had sensitivity of 89%, but
together, sensitivity 100%; conclusion that normal ECG and normal troponin I at 0 and 8 hr indicated no clinically
significant BCI
|
| Summary: clinically significant BCI includes myocardial damage affecting output, arrhythmias, and (rarely) valve and
wall disruption; no clear guidelines for at-risk patients; troponin I and ECG if applied to right patient population sensitive
screen for diagnosis of BCI
|
| Algorithm: patient with blunt chest trauma should have ECG and troponin I; if either positive, get echocardiography
and look for structural abnormalities and arrhythmias; if ECG and troponin I negative, repeat both in 8 hr; if either
positive at 8 hr, continue work-up; if negative, and other work-up completed, can discharge; sinus tachycardia, heart
rate variability or speed—majority of studies have omitted sinus tachycardia, so when studies look at electrical dysfunction
or conduction abnormalities, atrial fibrillation that requires treatment number-one arrhythmia
|
Suggested Reading
Czekajlo MS, Milbrant EB: Corticosteroids increased short and long-term mortality in adults with traumatic head injury.
Crit Care 9:E21, 2005; Eck JC et al: Questionnaire survey of spine surgeons on the use of methylprednisolone for acute spinal
cord injury. Spine 31:E250, 2006; Elie MC: Blunt cardiac injury. Mt Sinai J Med 73:542, 2006; Frampton AE, Eynon
CA: High dose methylprednisolone in the immediate management of acute, blunt spinal cord injury: what is the current practice
in emergency departments, spinal units, and neurosurgical units in the UK? Emerg Med J 23:550, 2006; Holanda MS et al:
Cardiac contusion following blunt chest trauma. Eur J Emg Med 13:373, 2006; Hurlbert RJ: Strategies of medical intervention
in the management of acute spinal cord injury. Spine 31:S16, 2006; Lai CH et al: A case of blunt chest trauma induced
acute myocardial infarction involving two vessels. In Heart J 47:639, 2006; Pai M: Diagnosis of myocardial contusion after
blunt chest trauma using 18F-FDG positron emission tomography. Br J Radiol 79:264, 2006; Rajan GP, Zellweger R: Cardiac
troponin I as a predictor of arrhythmia and ventricular dysfunction in trauma patients with myocardial contusion. J Trauma
57:801, 2004; Sauerland S, Maegele M: A CRASH landing in severe head injury. Lancet 364:1291, 2004; Sayer FT et al:
Methylprednisolone treatment in acute spinal cord injury: the myth challenged through a structured analysis of published literature.
Spine 6:335, 2006; Tsutsumi S et al: Effects of the Second National Acute Spinal Cord Injury Study of high-dose methylprednisolone
therapy on acute cervical spinal cord injury-results in spinal injuries center. Spine 31:2992, 2006; Vaquero J et
al: Early administration of methylprednisolone decreases apoptotic cell death after spinal cord injury. Histol Histopathol
21:1091, 2006; Wadia RS: Corticosteroid use in head injuries. Natl Med J India 18:25, 2005.
Educational Objectives
| The goal of this program is to increase awareness of the role of steroids in the treatment of spinal cord and head injuries
and improve screening for blunt cardiac injury. After hearing and assimilating this program, the clinician will be better
able to:
|
| 1. Explain the purported rationale for use of high-dose steroids in the treatment of spinal cord injury.
|
| 2. Explain why controversy exists about use of high-dose steroids in the treatment of spinal cord injury.
|
| 3. Discuss the standard of care and published guidelines for the use of methylprednisolone for spinal cord injury and
head injury.
|
| 4. Describe the spectrum of injury associated with cardiac injury and appraise the clinical significance of this diagnosis.
|
| 5. Assess the screening modalities available for the diagnosis of cardiac injury and how they fit into the work-up of
patients with blunt chest trauma.
|
Faculty Disclosure
In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty members to disclose relevant
financial relationships within the past 12 months that might create any personal conflicts of interest. Any identified conflicts
were resolved to ensure that this educational activity promotes quality in health care and not a proprietary business or commercial
interest. For this program, the faculty reports nothing to disclose.
Acknowledgements
Dr. Fitch was recorded at The 17th Annual June Jam, held June 9-11, 2006, in Myrtle Beach, SC, and sponsored by
the North Carolina College of Emergency Physicians. Dr. Inaba was recorded at the 13th Annual USC Trauma/Critical
Care Symposium, held May 22-23, 2006, in Pasadena, CA, and sponsored by the Division of Trauma/Critical
Care and the Office of Continuing Medical Education at the Keck School of Medicine of the University of Southern
California, and the Institute of Continuing Education for Nurses, Department of Nursing, Los Angeles, and USC
Medical Center. The Audio-Digest Foundation thanks the speakers and the sponsors for their cooperation in the production
of this program.
|
