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Emergency Resuscitation of Patients Enrolled in the US Diaspirin Cross-linked Hemoglobin (DCLHb) Clinical Efficacy Trial
- Edward P. Sloan, Max Koenigsberg, W. Brad Weir, James M. Clark, Robert O'Connor, Michael Olinger, Rita Cydulka
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- Journal:
- Prehospital and Disaster Medicine / Volume 30 / Issue 1 / February 2015
- Published online by Cambridge University Press:
- 15 December 2014, pp. 54-61
- Print publication:
- February 2015
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Introduction
Optimal emergent management of traumatic hemorrhagic shock patients requires a better understanding of treatment provided in the prehospital/Emergency Medical Services (EMS) and emergency department (ED) settings.
Hypothesis/ProblemDescribed in this research are the initial clinical status, airway management, fluid and blood infusions, and time course of severely-injured hemorrhagic shock patients in the EMS and ED settings from the diaspirin cross-linked hemoglobin (DCLHb) clinical trial.
MethodsData were analyzed from 17 US trauma centers gathered during a randomized, controlled, single-blinded efficacy trial of a hemoglobin solution (DCLHb) as add-on therapy versus standard therapy.
ResultsAmong the 98 randomized patients, the mean EMS Glasgow Coma Scale (GCS) was 10.6 (SD = 5.0), the mean EMS revised trauma score (RTS) was 6.3 (SD = 1.9), and the mean injury severity score (ISS) was 31 (SD = 17). Upon arrival to the ED, the GCS was 20% lower (7.8 (SD = 5.3) vs 9.7 (SD = 6.3)) and the RTS was 12% lower (5.3 (SD = 2.0) vs 6.0 (SD = 2.1)) than EMS values in blunt trauma patients (P < .001). By ED disposition, 80% of patients (78/98) were intubated. Rapid sequence intubation (RSI) was utilized in 77% (60/78), most often utilizing succinylcholine (65%) and midazolam (50%). The mean crystalloid volume infused was 4.2 L (SD = 3.4 L), 80% of which was infused within the ED. Emergency department blood transfusion occurred in 62% of patients, with an average transfused volume of 1.2 L (SD = 2.0 L). Blunt trauma patients received 2.1 times more total fluids (7.4 L vs 3.5 L, < .001) and 2.4 times more blood (2.4 L vs 1.0 L, P < .001). The mean time of patients taken from injury site to operating room (OR) was 113 minutes (SD = 87 minutes). Twenty-one (30%) of the 70 patients taken to the OR from the ED were sent within 60 minutes of the estimated injury time. Penetrating trauma patients were taken to the OR 52% sooner than blunt trauma patients (72 minutes vs 149 minutes, P < .001).
ConclusionBoth GCS and RTS decreased prior to ED arrival in blunt trauma patients. Intubation was performed using RSI, and crystalloid infusion of three times the estimated blood loss volume (L) and blood transfusion of the estimated blood loss volume (L) were provided in the EMS and ED settings. Surgical intervention for these trauma patients most often occurred more than one hour from the time of injury. Penetrating trauma patients received surgical intervention more rapidly than those with a blunt trauma mechanism.
. ,Sloan EP ,Koenigsberg M ,Weir WB ,Clark JM ,O'Connor R ,Olinger M .Cydulka R Emergency Resuscitation of Patients Enrolled in the US Diaspirin Cross-linked Hemoglobin (DCLHb) Clinical Efficacy Trial . Prehosp Disaster Med.2015 ;30 (1 ):1 -8
The Use of the Revised Trauma Score as an Entry Criterion in Traumatic Hemorrhagic Shock Studies: Data from the DCLHb Clinical Trials
- Edward P. Sloan, Max Koenigsberg, James M. Clark, Amol Desai
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- Journal:
- Prehospital and Disaster Medicine / Volume 27 / Issue 4 / August 2012
- Published online by Cambridge University Press:
- 30 July 2012, pp. 330-344
- Print publication:
- August 2012
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Introduction
The Revised Trauma Score (RTS) has been proposed as an entry criterion to identify patients with mid-range survival probability for traumatic hemorrhagic shock studies.
Hypothesis/ProblemDetermination of which of four RTS strata (1-3.99, 2-4.99, 1-4.99, and 2-5.99) identifies patients with predicted and actual mortality rates near 50% for use as an entry criterion in traumatic hemorrhagic shock clinical trials.
MethodsExisting database analysis in which demographic and injury severity data from two prior international Diaspirin Cross-Linked Hemoglobin (DCLHb) clinical trials were used to identify an RTS range that could be an optimal entry criterion in order to find the population of trauma patients with mid-range predicted and actual mortality rates.
ResultsOf 208 study patients, the mean age was 37 years, 65% sustained blunt trauma, 49% received DCLHb, and 57% came from the European Union study arm. The mean values were: ISS, 31 (SD = 18); RTS, 5.6 (SD = 1.8); and Glasgow Coma Scale (GCS), 10.4 (SD = 4.8). The mean TRISS-predicted mortality was 34% and the actual 28-day mortality was 35%. The initially proposed 1-3.99 RTS range (n = 41) had the highest predicted (79%) and actual (71%) mortality rates. The 2-5.99 RTS range (n = 79) had a 62% predicted and 53% actual mortality, and included 76% blunt trauma patients. Removal of GCS <5 patients from this RTS 2-5.99 subgroup caused a 48% further reduction in eligible patients, leaving 41 patients (20% of 208 total patients), 66% of whom sustained a blunt trauma injury. This subgroup had 54% predicted and 49% actual mortality rates. Receiver operator curve (ROC) analysis found the GCS to be as predictive of mortality as the RTS, both in the total patient population and in the RTS 2-5.99 subgroup.
ConclusionThe use of an RTS 2-5.99 inclusion criterion range identifies a traumatic hemorrhagic shock patient subgroup with predicted and actual mortality that approach the desired 50% rate. The exclusion of GCS <5 from this RTS 2-5.99 subgroup patients yields a smaller, more uniform patient subgroup whose mortality is more likely related to hemorrhagic shock than traumatic brain injury. Future studies should examine whether the RTS or other physiologic criteria such as the GCS score are most useful as traumatic hemorrhagic shock study entry criteria.
Sloan EP, Koenigsberg M, Clark JM, Desai A. The use of the Revised Trauma Score as an entry criterion in traumatic hemorrhagic shock studies: data from the DCLHb clinical trials. Prehosp Disaster Med. 2012;27(4):1-15.
A Safety Assessment of Diaspirin Cross-Linked Hemoglobin (DCLHb) in the Treatment of Hemorrhagic, Hypovolemic Shock
- Robert J. Przybelski, Elaine K. Daily, Jean Micheels, Edward Sloan, Pierre Mols, Luc Corne, Max D. Koenigsberg, William H. Bickell, Dan R. Thompson, Jay D. Harviel, Stephen M. Cohn
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- Journal:
- Prehospital and Disaster Medicine / Volume 14 / Issue 4 / December 1999
- Published online by Cambridge University Press:
- 28 June 2012, pp. 47-60
- Print publication:
- December 1999
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Objective:
To determine the safety and possible efficacy of diaspirin cross-linked hemoglobin (DCLHb) in the treatment of patients in Class II–IV hemorrhagic, hypovolemic shock.
Design:Multicenter, randomized, normal saline-controlled, dose-escalation study.
Setting:Eleven hospitals in the U.S. and Belgium.
Subjects:One hundred and thirty-nine (139) hospitalized patients with Class II–IV hemorrhagic, hypovolemic shock within the previous 4 hours who still were requiring therapy for shock.
Interventions:Beginning with the lowest dose, patients were randomized to receive 50,100, or 200 mL of either 10% DCLHb or normal saline infused intravenously over 15 minutes. Following infusion of either treatment, further fluid resuscitation could be given, as necessary, to maintain perfusion. Vital signs, laboratory assessments, blood and fluid administration, complications, and adverse events were recorded at various times from the end of infusion through 72 hours after infusion.
Results:A total of 29 (13 DCLHb- and 16 saline-treated) patients died during the study period. Adverse events were experienced by 61% of patients in the DCLHb group and 53% of patients in the saline group; serious adverse events occurred in 28% of DCLHb-treated patients and 30% of saline-treated patients. The incidence of prospectively defined, clinical complications, including renal insufficiency and renal failure, was similar between the treatment groups except for the occurrence of dysrhythmias/conduction disorders, which occurred significantly more frequently in the saline-treated patients than the DCLHb-treated patients (p = 0.041). At the highest dose level (200 mL), statistically significant between-group differences were observed with greater increases in serum amylase, LDH, the isoenzymes LD1,2,4 and 5, and CK-MB in the DCLHb group compared to the control group; none were of clinical significance. The volume of blood administered did not differ between the groups. Overall 24- and 72-hour survival rates were similar between treatment groups, although the hospital discharge rate was slightly higher in the DCLHb-treated patients (80%) compared with the saline-treated patients (74%).
Conclusion:Administration of 50 to 200 mL of DCLHb to patients in hemorrhagic, hypovolemic shock was not associated with evidence of end organ toxuity or significant adverse events. Further studies involving larger doses and, perhaps, earlier administration of DCLHb are warranted.
Prehospital Severity Scoring at Major Rock Concert Events
- Timothy B. Erickson, Max Koenigsberg, E. Bradshaw Bunney, Brian Schurgin, Paul Levy, Jacob Willens, Logan Tanner
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- Journal:
- Prehospital and Disaster Medicine / Volume 12 / Issue 3 / September 1997
- Published online by Cambridge University Press:
- 28 June 2012, pp. 22-26
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- September 1997
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Introduction:
Rock and contemporary music concerts are popular, recurrent events requiring on-site medical staffing.
Study objective:To describe a novel severity score used to stratify the level of acuity of patients presenting to first-aid stations at these events.
Methods:Retrospective review of charts generated at the first-aid stations of five major rock concerts within a 60,000 spectator capacity, outdoor, professional sports stadium. Participants included all concert patrons presenting to the stadiums first-aid stations as patients. Data were collected on patient demographics, history of drug or ethanol usage while at the concert event, first-aid station time, treatment rendered, diagnosis, and disposition. All patients evaluated were retrospectively assigned a “DRUG-ROCK” Injury Severity Score (DRISS) to stratify their level of acuity. Individual concert events and patient dispositions were compared statistically using chi-square, Fisher's exact, and the ANOVA Mean tests.
Results:Approximately 250,000 spectators attended the five concert events. First-aid stations evaluated 308 patients (utilization rate of 1.2 per 1,000 patrons). The most common diagnosis was minor trauma (130; 42%), followed in frequency by ethanol/illicit drug intoxication (98; 32%). The average time in the first-aid station was 23.5±22.5 minutes (± standard deviation; range: 5–150 minutes). Disposition of patients included 100 (32.5%) who were treated and released; 98 (32%) were transported by paramedics to emergency departments (EDs); and 110 (35.5%) signed-out against medical advise (AMA), refusing transport. The mean DRISS was 4.1 (±2.65). Two-thirds (67%) of the study population were ranked as mild by DRISS criteria (score = 1–4), with 27% rated as moderate (score = 5–9), and 6% severe (score >10). The average of severity scores was highest (6.5) for patients transported to hospitals, and statistically different from the scores of the average of the treated and released and AMA groups (p <0.005).
Conclusion:The DRISS was useful in stratifying the acuity level of this patient population. This severity score may serve as a potential triage mechanism for future mass gatherings such as rock concerts.
A Comparison of EMS Continuing Education for Paramedics in the United States
- Linda L. Herman, Paula J. Willoughby, Max D. Koenigsberg, Sharon Ward, Cary C. McDonald
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- Journal:
- Prehospital and Disaster Medicine / Volume 11 / Issue 4 / December 1996
- Published online by Cambridge University Press:
- 28 June 2012, pp. 292-295
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- December 1996
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Objective:
To determine characteristics of continuing education programs for paramedics in large metropolitan areas, and to make recommendations for changes in the Chicago Emergency Medical Services (EMS) system.
Design:A survey of 95 metropolitan areas from each state in the United States.
Participants:EMS medical directors, coordinators, and administrators.
Results:The survey population included 56 respondents. Within this group, 23% were from areas of 1 million people or more, 61% in areas with populations of 100,000 to 1 million and 16% from areas populated by < 100,000 people. Several system types were represented in the survey. In the systems surveyed, 98% mandate didactic continuing education requirements. Clinical continuing education was required by 34% of the systems. Ten systems (18%) awarded continuing education hours for documented in-field experience. This method did not have a specific structure by the majority of users. Both written and skills testing were used by most EMS systems to evaluate paramedic competency. No statistically significant differences (p >0.05) could be found among population subgroups or EMS system types when evaluating the use of these various methods.
Conclusion:EMS systems primarily use didactic sessions to meet their continuing education requirements. Nearly half of the systems requiring clinical continuing education use in-field credit to fulfill these requirements. In-field credit systems are poorly developed to date. This mechanism may be an effective alternative to usual clinical experiences for paramedics and deserves further investigation.
Medical Control of Mass Gatherings: Can Paramedics Perform Without Physicians On-site?
- Cary C. McDonald, Max D. Koenigsberg, Sharon Ward
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- Journal:
- Prehospital and Disaster Medicine / Volume 8 / Issue 4 / December 1993
- Published online by Cambridge University Press:
- 28 June 2012, pp. 327-331
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- December 1993
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Objective:
Evaluate the experience of paramedic personnel at mass gatherings in the absence of on-site physicians.
Design:Retrospective review of patients evaluated by paramedics with emergency medical services (EMS) medical control.
Setting:First-aid facility operated by paramedics at an outdoor amphitheater involving 32 (predominantly rock music) concerts in accordance with the Chicago EMS System, June through September 1990.
Participants:A total of 438 patients (≤0.1% on-site population) were evaluated.
Interventions:Presentations to the first-aid facility were viewed as if the patient was presenting to an ambulance. Transportation to an emergency department was strongly recommended for all encounters. Time from presentation to the first-aid facility until disposition was limited to 30 minutes in the absence of on-line [direct] medical control. Refusal of care was accepted. On-line [direct] medical control with the EMS resource hospital was initiated as needed. Off-line [indirect] medical control consisted of weekly reviews of all patient records and periodic site visits.
Results:Of the 438 patients, 366 (84%) refused further care, including 31 patients (7%) who refused advanced life support (ALS) level care. Seventy-two patients (16%) were transported; 37 by ALS and 35 by basic life support (BLS) units. On-line [direct] medical control was initiated in all ALS patients that were transported as well as for those who refused care. No known deaths or adverse outcomes occurred, based on lack of inquiries or complaints from the local EMS system, emergency departments receiving transported patients, law enforcement agencies, 9-1-1 emergency response providers, venue management, or security. No request for medical records from law firms have occurred. Problems noted initially were poor documentation and a tendency not to document all encounters (e.g., dispensing band-aids, tampons, earplugs, etc.). Concerns noted included: initial and subsequent vital signs, times of arrival, interventions, dispositions, and patient conditions of refusal. Specific problems with documentation of refusals at disposition included: appropriate mental status, speech, and gait; release with an accompanying family member or friend; and parental notification and approval of care for minors. There also was an initial tendency not to establish on-line [direct] medical control for ALS refusal or BLS medicolegal issues.
Conclusions:The medical system configuration modeled after practices of prehospital care, demonstrates physicians did not need to be onsite when adequate EMS medical control existed with less than 30 minutes on-scene time.
The Prehospital Use of Nitroglycerin According to Standing Medical Orders in an Urban EMS System
- Linda L. Herman, Max Koenigsberg, Sharon Ward, Edward P. Sloan
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- Journal:
- Prehospital and Disaster Medicine / Volume 8 / Issue 1 / March 1993
- Published online by Cambridge University Press:
- 28 June 2012, pp. 29-33
- Print publication:
- March 1993
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Purpose:
The purposes of this study are to quantify the use of nitroglycerin (NTG) in prehospital care, to detect deviations from the Standing Medical Orders (SMO), to determin the effectiveness of its administration, and the incidence of clinically significant adverse reactions (hypotension, bradycardia).
Method:Retrospective review of 7683 Advanced Life Support (ALS) telemetry, base-station contacts over a three month period (June, July, Auguest 1990) to identify all prehospital patient contacts in which NTG was utilized.
Setting:The Resource Hospital/Telemetry Base-Station a two community hospitals/Telemetry Base-Stations for the Chicago North EMS System.
Results:There were 445 runs in which NTG was indicated as per SMO. Two hundred eighty-eight patients (64.7%) received NTG for appropriate indications as per SMO, 203 for ischemic chest pain (45.6%), 79 for pulmonary edema (17.7%), and six for both (1.3%). There were 157 (35.5%) runs in which NTG was indicated, but not administered. There were 22 patients who received NTG for indications that deviated from the SMO. Reassessment data concerning the subjective symptom was completed on 118 patients (40.9%), 92 (45.3%) patients with chest pain and 26 with dyspnea (32.9%). Following the administration of NTG, 21 patients (10.1%) with chest pain were unchanged, while 13 with dyspnea (15.3%) improved, 13 patients (15.3%) were unchanged, and none worsened. In 121 patients, the systolic blood pressure (SBP) decreased, while 24 were unchanged (5.4%), and 28 had an increase (6.3%). The mean initial value SBP was 176±44 mmHg and the repeat mean SBP was 164±41 mmHg with a mean decrease of 12±22 mmHg. The diastolic blood pressure (DBP) decreased in 87 patients, was unchanged in 53 (11.9%), and increased in 33 (7.4%). The initial mean DBP was 97±24 mmHg, the repeat mean DBP was 92±23 mmHg, a mean decrease of 5±15 mmHg. Only one patient became hypotensive with the administration of NTG and was successfully resusticated with a fluid bolus of 300 ml normal saline.
Conclusions:In this EMS system, NTG is under-utilized based on the indications delineated by this system's SMOs. Reassessment is documented infrequently, but when completed, clinically significant adverse reactions are rare. Since the incidence of hypotension and bradycardia are rare, the inability to establish an IV line should not preclude the administration of NTG.
Seroconversion by EMS Personnel Vaccinated with HBV Recombinant DNA
- Max D. Koenigsberg, Sharon Ward, Linda Herman, Cary McDonald, Richard M. Feldman
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- Journal:
- Prehospital and Disaster Medicine / Volume 7 / Issue 4 / December 1992
- Published online by Cambridge University Press:
- 28 June 2012, pp. 373-379
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- December 1992
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Objective:
To evaluate the seroconversion rate of EMS personnel given the hepatitis B virus (HBV) recombinant deoxyribonucleic acid (DNA) vaccine series.
Design:Retrospective review of paramedics and firefighters consecutively completing the HBV recombinant DNA vaccine program.
Setting:Urban, non-prof it, private, regional EMS Resource Hospital. The Chicago North EMS System is under contract with the Chicago Fire Department. This contract allows for the voluntary vaccination of EMS personnel with recombinant DNA-HBV vaccine and treatment and follow-up of paramedics and firefighters possibly exposed to HBV.
Population:Initial 68 EMS personnel completing HBV recombinant DNA vaccine program (48 primary prophylaxis and 20 post-exposure prophylaxis).
Intervention:HBV recombinant DNA vaccine series was administered voluntarily to Chicago EMS System paramedics and firefighters per manufacturers recommendations. Two weeks after completion of the vaccination series, blood samples for HBV antibody titres were drawn to determine reactivity and the need for further immunization.
Results:Of the 68 vaccinated individuals, only two had negative titres (3%). These two individuals were given a fourth dose of vaccine with successful seroconversion.
Conclusions:Prehospital care personnel are known highrisk, health-care workers for acquiring HBV and should be vaccinated prophylactically. There is a high seroconversion rate (97%) utilizing HBV recombinant DNA vaccine. However, post-vaccination antibody titres must be performed to identify those rare individuals that do not seroconvert.