ACEP News - June 2008 - (Page 10)

TRAUMA ACEP NEWS • J U N E 2 0 0 8 Studies Challenge Spine Injury Criteria for Children BY DOUG BRUNK Else vier Global Medical Ne ws C O R O N A D O , C A L I F. — A growing number of published reports are challenging the validity of using the five National Emergency X-Radiography Utilization Study criteria to diagnose spine injury in children. The criteria (posterior midline cervical tenderness; no evidence of intoxication; normal level of alertness; no focal neurologic deficit; and no painful, distracting injury) were established in a study of 34,069 trauma victims that presented to 21 emergency departments nationwide (N. Engl. J. Med. 2000;343:94-9). Of these, 818 (2.4%) had cervical spine injury. The researchers reported that the criteria were 99% sensitive for cervical spine injury and 99.6% sensitive for clinically significant cervical spine injury in adults. The specificity was 12.9% in both groups. In a subset analysis of 3,065 children from the National Emergency X-Radiography Utilization Study (NEXUS) study, 30 had cervical spine injuries (Pediatrics 2001; found that the criteria were 94% sensitive 108:E20). The NEXUS criteria for detect- among children aged less than 8 years and ing cervical spine injury were 100% sensi- 100% sensitive in those greater than age 8 tive and 19.9% specific. However, none of years (Neurosurgery 2008;62:700-8). A Pediatric Emergency Care the children studied was Applied Research Network younger than 2 years, and only study led by Dr. Leonard found 817 (27%) were younger than that the NEXUS criteria were age 8 years. 83% sensitive among 539 chil“For now, until we come up dren with spinal injury who with pediatric-specific criteria, presented to the emergency deit’s reasonable to apply the partment. Of the 90 children NEXUS criteria to awake and missed by the NEXUS criteria, alert patients,” Dr. Julie C. 58 (64%) were younger than 8 Leonard said at a pediatric emergency medicine meeting Of the 90 children years of age. Dr. Leonard, an instructor in sponsored by the American missed by the pediatric emergency medicine College of Emergency PhysiNEXUS criteria, at Washington University, St. cians. “However, if you have a 64% were Louis, said that a risk-stratificahigh index of suspicion by eiyounger than tion system should be devised ther mechanism or self-re8 years of age. and applied to the NEXUS criported pain, you should use DR. LEONARD teria in order to achieve optimal your clinical acumen and purdiagnostic benefit for pediatric patients. sue an evaluation.” “There are age-dependent anatomic difA recent single-center, 20-year review that applied the NEXUS criteria to 190 chil- ferences in spine injury, differing injury dren with significant cervical spine injury patterns and mechanisms, and age-related differences in the ability to localize pain,” she explained, adding that high-risk populations also need to be considered, such as those with Down syndrome, juvenile idiopathic arthritis, and disorders of bone metabolism. Cervical spine injuries are rare events in pediatrics. They occur in less than 1% of pediatric blunt trauma victims, or 18 cervical spine injuries per year per million children. “Of these, less than two-thirds of these injuries are clinically significant,” Dr. Leonard said. Overall, the most common cause of cervical spine injury in children is motor vehicle collision, followed closely by falls/diving. Sports-related injuries are a common cause among teens, Dr. Leonard said, while motor vehicle collisions are common among early school-age children. Child abuse probably is an underreported cause of injury in infants and toddlers. Dr. Leonard had no conflicts to disclose. ■ Blood Substitute Impresses, But Safety Under Scrutiny B Y M I C H E L E G. S U L L I VA N Else vier Global Medical Ne ws N E W O R L E A N S — A blood substitute made of human hemoglobin extracted from expired donated blood can be used in emergencies when packed red cells are unavailable, according to recent phase III trial results. Survival rates of patients with traumatic injury who received the polymerized hemoglobin product (PolyHeme) before hospital transport were similar to those of patients who received crystalloid, and no increase in multisystem organ failure was seen, Dr. Ernest Moore said at the annual clinical congress of the American College of Surgeons. “PolyHeme is safe when used as an initial oxygen carrier. I’m not saying it should be used in lieu of packed red cells, but it can be used when that option is not available,” said Dr. Moore, vice-chairman of surgery at the University of Colorado Health Sciences Center, Denver, and the trial’s principal investigator. Dr. Gary Vercruysse, who was asked to comment on the study, agreed. “What do you do with someone who is terribly injured and needs blood but you are not able to give it to them? Ideally, it would be nice to resuscitate people in the field without crystalloid, but that hasn’t been possible to this point. This trial showed that PolyHeme is not inferior to whole blood or crystalloid, and has the potential to show a survival benefit,” Dr. Vercruysse, a trauma surgeon at Grady Memorial Hospital, Atlanta, said in an interview. The study involved 32 U.S. institutions, 300 physician investigators, and 1,500 emergency medical technicians. Trauma patients who were at least 18 years old and had a systolic blood pressure of at least 90 mm Hg were eligible for inclusion. Patients who were considered unsalvageable or whose Glasgow Coma Scale grade was less than 5 were excluded. A total of 714 patients were enrolled in the trial, Dr. Moore said. The patients’ mean age was 37 years, and most (78%) were male. Penetrating wounds were present in 53% of the patients; the rest had blunt injuries. Their mean systolic blood pressure was 78 mm Hg. Control patients (365) received crystalloid in the field, followed by packed red cells as necessary for the next 12 hours. PolyHeme patients (349) got the blood substitute in the field and, over the next 12 hours, up to 6 more units as needed. Patients in both groups who needed additional transfusions after 12 hours received packed red cells. The 12-hour, in-hospital extension was added on the basis of a phase II trial showing that severely injured patients who got PolyHeme had lower rates of multiorgan failure than did those who received stored red blood cells. The main end points of the trial were 30-day mortality, multiple organ failure, and adverse events. Mortality was not significantly different between the control group and the PolyHeme group (10% versus 13%, respectively), nor was multiple organ failure (6% of controls versus 7% of PolyHeme patients). Significantly more PolyHeme patients than control patients had adverse events (93% vs. 88%, respectively), but the difference for serious adverse events was not significant (40% of the PolyHeme group vs. 35% of the controls). Similarly, significantly more myocardial infarctions occurred among PolyHeme patients than among controls (11 vs. 3, or 3% vs. 1%, respectively), but only one patient in each group required intervention, according to Dr. Moore. An independent group of cardiologists is reviewing these data as well as the cardiac profiles of all the patients in the trial, Dr. Moore said. Although the cause of the cardiac problems in the PolyHeme group is unclear, Dr. Vercruysse said that at no point during the trial was the independent safety monitoring board alarmed enough to intervene in the study. “This panel examined the safety data after 60, 120, 250, and 500 patients were accrued, and there was never any adjustment in the study or breaking of the blind to evaluate any safety imbalances.” Clinical trials of PolyHeme began in 1986. In 2006, a Wall Street Journal article raised public concern about the possibility of increased heart attacks in those who received the product, citing unpublished results of an earlier phase III trial of 152 patients in which MIs occurred in 10 PolyHeme recipients, 2 of whom died. None of those who received donated whole blood had an MI. That study examined the use of the blood substitute in elective surgery. “This was a trial of preoperative autologous blood donation, using PolyHeme to increase the red blood cell donation in patients undergoing elective abdominal aneurysm repair,” Dr. Moore said. “It was terminated at the first interim analysis because of a reportedly flawed study design,” which led to PolyHeme patients having 60% of their blood volume withdrawn versus 30% in the control group. Northfield Labs Inc., the maker of PolyHeme, responded to the article in a news release on the company’s Web site: “In keeping with the protocol, the PolyHeme group also received substantially more fluids than did the controls, resulting in complex issues with fluid management in those patients.” The Wall Street Journal article insinuated that Northfield hastily stopped the trial and then buried news of the adverse events by refusing to publish the results. According to Northfield’s press release, the trial closed in 2000 because of inadequate patient enrollment. Dr. Moore said that the data from this earlier phase III trial were fully reported to the Food and Drug Administration and formed the basis of several published reports. The 32 institutional boards of review that approved the trauma trial also had full access to the data, he added. But the newspaper article set off a chain reaction in the legal community, and five class action lawsuits were filed against Northfield. The current trial included patients who could not be identified prospectively, were in a life-threatening situation, and were unable to give fully informed consent to their randomization. This again raised red flags in the media; patient advocacy and community action groups protested, and ethicists published several opinion pieces, Dr. Vercruysse said. In an effort to reassure the communities involved in the trial, the study group sent out pub

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ACEP News - June 2008 Contents News - Time to Move Tricks of the Trade - Revealing Tips Focus On - Dengue Fever Practice Trends - EMTALA Results

ACEP News - June 2008

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