"Keeping You Up-to-Date with Current Literature" Brought to you by the EAST Manuscript and Literature Review Committee
This issue was prepared by EAST Manuscript and Literature Committee Members Christopher D. Barrett, MD, Sneha Bhat, MD and EAST Member Michelle D. Lippincott, MD.
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In This Issue: Surgical Critical Care
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Article 1 reviewed by Sneha Bhat, MD Prehospital Tranexamic Acid for Severe Trauma. The PATCH-Trauma Investigators and the ANZICS Clinical Trials Group.N Engl J Med. 2023 Jul 13;389(2):127-136.
Hemorrhage is a major cause of preventable death in trauma, and tissue injury combined with shock leading to plasmin-mediated hyperfibrinolysis plays a significant role in trauma-induced coagulopathy. Mitigating these effects is an important part of optimizing the management of traumatically injured patients. The administration of tranexamic acid (TXA), an anti-fibrinolytic agent, has previously been studied in trauma where early administration and use in hypotensive patients has shown clear all-cause and bleeding-related mortality benefit. However, long-term functional outcomes have not been studied outside of the brain injury literature with respect to TXA. To address this, the PATCH trial authors aimed to study whether pre-hospital administration of TXA leads to survival with a favorable functional outcome at 6 months after injury (as defined by a Glasgow Outcome Scale- Extended [GOS-E] score>5), as well as secondary outcomes of 24-hour, 28-day, and 6-month mortality.
In this double-blind, randomized placebo-controlled trial including 15 EMS services and 21 hospitals in Australia, New Zealand, and Germany, adult trauma patients with suspected severe trauma were randomized to an intervention arm of 1-gram TXA IV pushed over 10 minutes, followed by a second gram infused over 8 hours, versus a matching placebo control arm. Adults (>18 years) with suspected severe injuries who were thought to be at risk of trauma-induced coagulopathy (based on Coagulopathy of Severe Trauma [COAST] score>3), and in whom the study drug could be given within 3 hours, were included. Pregnant patients and older patients who resided in a facility were excluded from this study.
A total of 1310 patients were initially enrolled, with 1131 patients included (TXA n=572, placebo n=559) in the primary intention-to-treat analysis after eliminating those with loss to follow-up, withdrawal of consent, and patients in whom the study packs were lost. Patient demographics were similar between the two groups: average age of 44 years and predominantly male (70%). Study patients had a median injury severity score of 29 and 24% noted to have laboratory evidence of early coagulopathy. With respect to the primary outcome, there was no difference in survival with favorable functional outcome at 6months (TXA 53.7% vs placebo 53.5%, RR 1.00, 95%CI 0.9-1.12, p=0.95). Mortality at 6 months was also not statistically different between the groups (19% vs 23%, RR 0.83, 95%CI 0.67-1.03). There was, however, improvement in 24-hour and 28-day mortality with TXA administration, consistent with previous trials. When analyzing the GOS-E breakdown of the study population, the administration of TXA shifted patients from death and/or vegetative state to the most severe class of disability. However, similar numbers of moderate disability and good recovery were identified between both groups.
There are several limitations to this trial, including a loss to follow-up of 13% of the population, as well as protocol variations occurring in over 30% of patients in both groups, including 15% of patients receiving open-label TXA. Additionally, TXA was administered IV as a 1-g bolus before hospital admission, followed by a 1-g infusion over 8 hours in-hospital, which may vary from many other institutions’ practice patterns for dosing as some practices have now moved to a 2g bolus-only approach. Finally, outcomes were only captured for a maximum of 6-months after injury, while functional recovery can still occur beyond this timepoint.
In summary, favorable functional outcome at 6 months was not altered with the administration of TXA in severely injured trauma patients, suggesting a need for further research to identify which trauma patients have meaningful clinical benefit from TXA administration.
Surgical stabilization of rib fractures (SSRF) has demonstrated efficacy in treating trauma patients with clinical flail chest and respiratory failure secondary to chest wall injury. However, the role of SSRF for patients without clinical flail chest or respiratory failure remains poorly defined. The study by Meyeret alaimed to address this knowledge gap and determine if SSRF was beneficial to patients with severe chest wall injury in the absence of clinical flail chest.
In this single-center randomized controlled trial, the authors compared SSRF plus usual care to usual care alone. Inclusion criteria were defined as age ≥16 years and a radiographic flail segment, five or more consecutive rib fractures, or any single rib fracture with bi-cortical displacement. Additionally, at least one of the true ribs (1-7) had to be accessible for surgical stabilization. Patients were excluded if they had clinical flail chest, severe brain or spinal cord injury, congestive heart failure, oxygen-dependent pulmonary disease at baseline, or lacked clinical equipoise. Usual care was defined by an institutional protocol consisting of an oral multimodal regimen with as-needed intravenous analgesia. The intervention arm was defined as the surgical fixation of at least one true rib using any commercially available rib fixation kit or technique. The use of regional anesthesia during fixation was not allowed, as it presumably would have skewed the pain management data relative to the usual care group who frequently are unable to get regional anesthesia for multifactorial reasons.
A total of 84 patients were randomized with equal distribution between SSRF and usual care, and comparison made via intention-to-treat analysis. Injury patterns, patient demographics, and injury severity were similar between the two study groups. The primary outcome, hospital length of stay (LOS) was significantly longer for the SSRF group (9 d vs 6 d, p=0.005). The SSRF group had significantly more inpatient opioid exposure (349mg vs 177mg, p=0.001), although after adjusting for the portion of opioids received as part of operative anesthesia statistical significance was lost. However, while no longerstatisticallysignificant the absolute differences in opioid exposure after removing opioids received under anesthesia remained large with nearly twice as much exposure in the SSRF group (203mg vs 125mg, p=0.088). At 1 month, SSRF patients had significantly greater impairment in mobility and self-care than their non-surgical counterparts, but these differences were no longer observed at 3 and 6 months. Other secondary outcomes including complication rates and discharge to home were similar between the study groups.
The study had multiple limitations, including that it was underpowered secondary to COVID-related issues and that with respect to their primary outcome, the longer hospital LOS in the SSRF group may have directly resulted from the study design itself. The patients in the SSRF took approximately 3-4 days to go to surgery due to the time taken to obtain study consent and then subsequently find operating room (OR) availability, whereas non-study SSRF patients typically go to the OR within 1-2 days as it is just a matter of finding OR time.
Despite these limitations, the study authors concluded that they were unable to identify a benefit in short- or long-term outcomes to support rib fixation in patients with severe chest wall injury who lack clinical flail chest. While this study serves to question the role of surgical rib fixation in patients without clinical flail chest, its multiple limitations render further adequately powered studies needed to further address this important clinical knowledge gap.
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This Literature Review is being brought to you by the EAST Manuscript and Literature Review Committee. Have a suggestion for a review or an additional comment on articles reviewed? Please email litreview@east.org. Previous issues available on the EAST website.
