EMS World

OCT 2018

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EMSWORLD.com | OCTOBER 2018 17 sion criteria and included 65 patients in the plasma group and 60 in the control group. The results we will discuss in this review are from the as-treated analysis. Results In the as-treated analysis, the plasma group included 52 (80%) males and 13 (20%) females. The saline control group included 51 (85%) men and 9 (15%) women. Median ages were 33 years for the plasma group and 32.5 years for the control group. The median transport time was 19 minutes for the plasma group and 16 minutes for the saline group (p=0.04). All 65 patients in the plasma group received two full plasma units, with 21 (32%) receiving two units during transport, 24 (37%) receiving one unit during transport and a second in the emergency depart- ment, and 20 (31%) starting the first plasma unit during transport but, after its completion, having a second administered in the emer- gency department. When comparing the two groups, the relative risk of death within 28 days was 1.54 with a 95% confidence interval of 0.60–3.98. Ten (15%) patients died within 28 days in the plasma group, and 6 (10%) in the control group (p=0.37). Now, let's get back to the sample size calculation that said this study needed to enroll 150 patients. Clinical trials are monitored by data safety monitoring boards. Essentially this board evaluates the results at specific intervals throughout the study to determine whether the study is safe for patients and should continue. Throughout this study the board found no difference in mortality between the groups in either analysis. After 144 patients were enrolled, the data safety monitoring board and FDA deemed the study futile and approved its termination because "the outcome had not differed in any of the interim analyses, indicating that no difference should be anticipated." It should be noted that this comparison occurred in an urban envi- ronment with relatively short transport times to a Level 1 trauma center. The authors stated that while no improvement in clinical outcomes was found, no adverse events were found either. They indicated further study is necessary because the use of plasma might be beneficial in rural or wilderness environments with longer transport times. Limitations As with all studies, this study had some limitations. The authors noted that some hypotension may not have been due to hemor- rhage, which may account for the lack of effect seen in the plasma group. Further, assignment of patients to the control group may have freed paramedics from performing additional tasks related to plasma administration, allowing them to better focus on patient care. Finally, this study took place in a system that had plasma imme- diately available upon arrival at the hospital. Results may differ in other systems. ABOUT THE AUTHOR Antonio R. Fernandez, PhD, NRP, FAHA, is research director at the EMS Performance Improvement Center and an assistant professor in the Department of Emergency Medicine at the University of North Carolina–Chapel Hill. EMSWORLD.com | OCTOBER 2018 17 www.indeelift.com IndeeLift; Bridging the gap between ground and gurney! Designed and built in the USA These products are covered by one or more patents, including U.S. Patent No. 9,808,388 B2 7KHŴDJVKLS(06PRGHO+)/(ZHLJKVLQDWRQO\ OEV\HWFRPIRUWDEO\OLIWVDQGWUDQVSRUWVSDWLHQWV ZHLJKLQJLQH[FHVVRIOEV ,QGHHOLIWSURWHFWVSDWLHQWVDQGSURYLGHUVE\HOLPLQDWLQJPDQXDO OLIWLQJZKLOHSURYLGLQJJUHDWHUFRPIRUWDQGSDWLHQWGLJQLW\IRU ERWKOLIWDQGWUDQVIHUQHHGV%HLQJGUDJJHGRQDWDUSLVQRWRQO\ KXPLOLDWLQJEXWGDQJHURXVIRUWKHSDWLHQWDQGSURYLGHU*LYH \RXUSDWLHQWVWKHUHVSHFWWKH\GHVHUYHDQGGR\RXUEDFN DIDYRUDWWKHVDPHWLPH "IndeeLift is the safest way to pick up a patient for the patient and the provider!" — Fire Captain/Paramedic Kurtis Dickey SAFE PATIENT HANDLING BEGINS WITH INDEELIFT IndeeLift: The safe way to lift and transport patients For More Information Circle 18 on Reader Service Card

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