Damage control laparotomy in trauma: a pilot randomized controlled trial. The DCL trial.

BACKGROUND: Although widely used in treating severe abdominal trauma, damage control laparotomy (DCL) has not been assessed in any randomized controlled trial. We conducted a pilot trial among patients for whom our surgeons had equipoise and hypothesized that definitive laparotomy (DEF) would reduce major abdominal complications (MAC) or death within 30 days compared with DCL. METHODS: Eligible patients undergoing emergency laparotomy were randomized during surgery to DCL or DEF from July 2016 to May 2019. The primary outcome was MAC or death within 30 days. Prespecified frequentist and Bayesian analyses were performed. RESULTS: Of 489 eligible patients, 39 patients were randomized (DCL 18, DEF 21) and included. Groups were similar in demographics and mechanism of injury. The DEF group had a higher Injury Severity Score (DEF median 34 (IQR 20, 43) vs DCL 29 (IQR 22, 41)) and received more prerandomization blood products (DEF median red blood cells 8 units (IQR 6, 11) vs DCL 6 units (IQR 2, 11)). In unadjusted analyses, the DEF group had more MAC or death within 30 days (1.71, 95% CI 0.81 to 3.63, p=0.159) due to more deaths within 30 days (DEF 33% vs DCL 0%, p=0.010). Adjustment for Injury Severity Score and prerandomization blood products reduced the risk ratio for MAC or death within 30 days to 1.54 (95% CI 0.71 to 3.32, p=0.274). The Bayesian probability that DEF increased MAC or death within 30 days was 85% in unadjusted analyses and 66% in adjusted analyses. CONCLUSION: The findings of our single center pilot trial were inconclusive. Outcomes were not worse with DCL and, in fact, may have been better. A randomized clinical trial of DCL is feasible and a larger, multicenter trial is needed to compare DCL and DEF for patients with severe abdominal trauma. LEVEL OF EVIDENCE: Level II.

Multi-Modal Analgesic Strategy for Trauma: A Pragmatic Randomized Clinical Trial.

BACKGROUND: An effective strategy to manage acute pain and minimize opioid exposure is needed for injured patients. In this trial, we aimed to compare 2 multimodal pain regimens (MMPRs) for minimizing opioid exposure and relieving acute pain in a busy, urban trauma center. METHODS: This was an unblinded, pragmatic, randomized, comparative effectiveness trial of all adult trauma admissions except vulnerable patient populations and readmissions. The original MMPR (IV administration, followed by oral, acetaminophen, 48 hours of celecoxib and pregabalin, followed by naproxen and gabapentin, scheduled tramadol, and as-needed oxycodone) was compared with an MMPR of generic medications, termed the Multi-Modal Analgesic Strategies for Trauma (MAST) MMPR (ie oral acetaminophen, naproxen, gabapentin, lidocaine patches, and as-needed opioids). The primary endpoint was oral morphine milligram equivalents (MMEs) per day and secondary outcomes included total MMEs during hospitalization, opioid prescribing at discharge, and pain scores. RESULTS: During the trial, 1,561 patients were randomized, 787 to receive the original MMPR and 774 to receive the MAST MMPR. There were no differences in demographic characteristics, injury characteristics, or operations performed. Patients randomized to receive the MAST MMPR had lower MMEs per day (34 MMEs/d; interquartile range 15 to 61 MMEs/d vs 48 MMEs/d; interquartile range 22 to 74 MMEs/d; p < 0.001) and fewer were prescribed opioids at discharge (62% vs 67%; p = 0.029; relative risk 0.92; 95% credible interval, 0.86 to 0.99; posterior probability relative risk <1 = 0.99). No clinically significant difference in pain scores were seen. CONCLUSIONS: The MAST MMPR was a generalizable and widely available approach that reduced opioid exposure after trauma and achieved adequate acute pain control.

Implementation of a multi-modal pain regimen to decrease inpatient opioid exposure after injury.

INTRODUCTION: In 2013, we implemented a pill-based, multi-modal pain regimen (MMPR) in order to decrease in-hospital opioid exposure after injury at our trauma center. We hypothesized that the MMPR would decrease inpatient oral morphine milligram equivalents (MME), decrease opioid prescriptions at discharge, and result in similar Numerical Rating Scale (NRS) pain scores. METHODS: Adult patients admitted to a level-1 trauma center with ≥1 rib fracture from 2010 to 2017 were included - spanning 3 years before and 4 years after MMPR implementation. MME were summarized as medians and interquartile range (IQR) by year of admission. The effect of the MMPR on daily total MME was estimated using Bayesian generalized linear model. RESULTS: Over the 8 year study period, 6,933 patients who met study inclusion criteria were included. No significant differences between years were observed in Abbreviated Injury Scale (AIS) Chest or Injury Severity Scores (ISS). After introduction of the MMPR, there was a significant reduction in median total MME administered per patient day from 60 MME/patient day (IQR 36-91 MME/patient day) pre-MMPR implementation to 37 MME/patient day (IQR 18-61 MME/patient day) in 2017, p < 0.01. Total MME administered per patient day decreased by 31% in 2017 as compared to 2010 (rate ratio 0.69, 95% CI 0.64-0.75). Average NRS pain scores decreased by 0.8 points (95% CI -0.87, -0.81) from 2010 to 2017. CONCLUSION: The introduction of a multi-modal pain regimen resulted in significant reduction in in-patient opioid exposure after injury. The reduction in inpatient opioid use from 2010 to 2017 was equivalent to 11 mg less oxycodone or 17 mg less hydrocodone per patient per day. Additionally, use of the MMPR was associated with a reduction in NRS pain scores.

The effect of damage control laparotomy on major abdominal complications: A matched analysis.

INTRODUCTION: Damage control laparotomy (DCL) for trauma is thought to be associated with increased abdominal complications. The purpose of this study is to determine the effect of DCL on abdominal complications by comparing two groups of trauma patients: DCL patients who were prospectively adjudicated to potentially being closed at the primary laparotomy (potential DEF or pDEF) and those who underwent definitive laparotomy (DEF). METHODS: The pDEF group was matched to DEF patients according to mechanism of injury, abdominal injury severity, operating room transfusions, and performance of a colon resection. The primary outcome was major abdominal complications (MAC), a composite variable. RESULTS: No statistically significant difference in the primary outcome, major abdominal complications, were seen (pDEF 19% versus DEF 56%, p = 0.066). The pDEF group was more likely to have a fascial dehiscence (38% versus 0%, p = 0.018), and to be re-opened after fascial closure (38% versus 0%, p = 0.018). CONCLUSION: Damage control laparotomy was associated with clinically but not statistically significant increase in rates of MAC. Increased numbers of patients to analyze in this fashion is needed.

Damage-control resuscitation increases successful nonoperative management rates and survival after severe blunt liver injury.

BACKGROUND: Nonoperative multidisciplinary management for severe (American Association for the Surgery of Trauma Grades IV and V) liver injury has been used for two decades. We have previously shown that Damage Control Resuscitation (DCR) using low-volume, balanced resuscitation improves survival of severely injured trauma patients; however, little attention has been paid to organ-specific outcomes. We wanted to determine if implementation of DCR has improved survival and successful nonoperative management after severe blunt liver injury. METHODS: A retrospective study was performed on all adult trauma patients with severe blunt liver injury who were admitted from 2005 to 2011. Patients were divided into pre-DCR (2005-2008) and DCR (2009-2011) groups. Patients who died before leaving the emergency department (ED) were excluded. Outcomes (resuscitation products used, survival, and length of stay) were then compared by univariate and multivariate analyses. RESULTS: Between 2005 and 2011, 29,801 adult trauma patients were admitted, and 1,412 (4.7%) experienced blunt liver injury. Of these, 244 (17%) sustained Grade IV and V injuries, with 206 patients surviving to leave the ED. The pre-DCR group (2005-2008) was composed of 108 patients, and the DCR group (2009-2011) had 98 patients. The groups were not different in demographics as well as prehospital and ED vital signs or Injury Severity Score (ISS). No change in operative or interventional radiology techniques occurred in this time frame. The DCR cohort had an increase in successful nonoperative management (from 54% to 74%, p < 0.01) as well as a reduction in initial 24-hour packed red blood cell (median, from 13 U to 6.5 U; p < 0.01), plasma (median, from 13 U to 8 U; p < 0.01), and crystalloid (median, from 5,800 mL to 4,100 mL; p < 0.01) administration. The DCR treatment was associated with improved survival, from 73% to 94% (p < 0.01). CONCLUSION: In patients with severe blunt liver injury, DCR was associated with less crystalloid and blood product use, a higher successful nonoperative management rate, and improved survival. Resuscitation technique may improve outcomes after severe liver injury. LEVEL OF EVIDENCE: Therapeutic/care management, level III.

Technical and financial feasibility of an inferior vena cava filter retrieval program at a level one trauma center.

BACKGROUND: Considering new guidelines for retrievable inferior vena cava filters (IVCFs), we examine our initial experience after establishing a comprehensive filter removal program in our level 1 trauma center. We evaluated the technical and financial feasibility of this program and barriers to IVCF retrieval, including insurance status and costs, in trauma patients. METHODS: Trauma patients receiving IVCFs from May 2011 to 2013 were consented and prospectively enrolled in the study program. Retrieval rates were assessed for the years before study initiation. Primary outcome was IVCF retrieval. Hospital financial data for retrieval were examined and univariate analysis performed. Hospital cost-to-charge and payment-to-charge ratios were assessed. RESULTS: Before study initiation from April 2009 to 2011, 66 IVCFs were placed in trauma patients with only 2 retrievals in 2 years. During the study period, 247 trauma patients had IVCF placement of which 111 (45%) were enrolled. The main reason for nonenrollment was lack of referral by the implanting team. Retrieval was attempted in 100 outpatients with success in 85 (85%). Patients enrolled in the program were more likely to have their filters removed (73% vs. 18%; odds ratio, 12.6; 95% confidence interval, 6.6-24.3; P < 0.001). Mean time from placement to attempt was 6.2 ± 4.0 months (range, 0.5-31.8). Of the total attempts, 29% were nonresource patients, 11% had Medicaid, and 60% had commercial insurance including Medicare patients. Chances of successful retrieval were higher if performed later during the study (P = 0.03). Successful retrieval was not related to insurance status (P = not significant). The mean total hospital charges related to retrieval were $4,493 (range, $2,510-$9,106). Successful retrieval contributed to lower total charges (P < 0.01). Factors contributing to higher total charges were retrieval attempt later in study period (P = 0.01) and commercial insurance status (P = 0.04). CONCLUSIONS: The rate of IVCF placement in trauma patients increased 4-fold over 4 years. The rate of IVCF retrieval increased more than 14-fold during the same period after establishment of the retrieval program. Elective outpatient retrieval of IVCFs in all eligible trauma patients is financially feasible without loss to the health care system even in regions with high rates of uninsured. A major barrier to successful filter retrieval was lack of patient referral into the program by implanting physicians. Hospital administration and physician outreach are important determinants of successful IVCF retrieval in trauma patients.

A clinical series of resuscitative endovascular balloon occlusion of the aorta for hemorrhage control and resuscitation.

BACKGROUND: A requirement for improved methods of hemorrhage control and resuscitation along with the translation of endovascular specialty skills has resulted in reappraisal of resuscitative endovascular balloon occlusion of the aorta (REBOA) for end-stage shock. The objective of this report was to describe implementation of REBOA in civilian trauma centers. METHODS: Descriptive case series of REBOA (December 2012 to March 2013) used in scenarios of end-stage hemorrhagic shock at the University of Maryland, R. Adams Cowley Shock Trauma Center, Baltimore, Maryland, and Herman Memorial Hospital, The Texas Trauma Institute, Houston, Texas. RESULTS: REBOA was performed by trauma and acute care surgeons for blunt (n = 4) and penetrating (n = 2) mechanisms. Three cases were REBOA in the descending thoracic aorta (Zone I) and three in the infrarenal aorta (Zone III). Mean (SD) systolic blood pressure at the time of REBOA was 59 (27) mm Hg, and mean (SD) base deficit was 13 (5). Arterial access was accomplished using both direct cutdown (n = 3) and percutaneous (n = 3) access to the common femoral artery. REBOA resulted in a mean (SD) increase in blood pressure of 55 (20) mm Hg, and the mean (SD) aortic occlusion time was 18 (34) minutes. There were no REBOA-related complications, and there was no hemorrhage-related mortality. CONCLUSION: REBOA is a feasible and effective means of proactive aortic control for patients in end-stage shock from blunt and penetrating mechanisms. With available technology, this method of resuscitation can be performed by trauma and acute care surgeons who have benefited from instruction on a limited endovascular skill set. Future work should be aimed at devices that allow easy, fluoroscopy-free access and studies to define patients most likely to benefit from this procedure. LEVEL OF EVIDENCE: Therapeutic study, level V.

Admission rapid thrombelastography can replace conventional coagulation tests in the emergency department: experience with 1974 consecutive trauma patients.

OBJECTIVE: Injury and shock lead to alterations in conventional coagulation tests (CCTs). Recently, rapid thrombelastography (r-TEG) has become recognized as a comprehensive assessment of coagulation abnormalities. We have previously shown that admission r-TEG results are available faster than CCTs and predict pulmonary embolism. We hypothesized that r-TEGs more reliably predict blood component transfusion than CCTs. METHODS: Consecutive patients admitted between September 2009 and February 2011 who met the highest-level trauma activations were included. All had admission r-TEG and CCTs. We correlated r-TEG values [activated clotting time (ACT), r, k, α, maximal amplitude (MA), LY30] with their corresponding CCTs [prothrombin time (PT)/activated partial thromboplastin time (aPTT), international normalized ratio (INR), platelet count and fibrinogen] for transfusion requirements. Charges were calculated for each test. Demographics, vital signs, and injury severity were recorded. RESULTS: We studied 1974 major trauma activations. The median injury severity score was 17 [interquartile range 9-26]; 25% were in shock; 28% were transfused; and 6% died within 24 hours. Overall, r-TEG correlated with CCTs. When controlling for age, injury mechanism, weighted-Revised Trauma Score, base excess and hemoglobin, ACT-predicted red blood cell (RBC) transfusion, and the α-angle predicted massive RBC transfusion better than PT/aPTT or INR (P < 0.001). The α-angle was superior to fibrinogen for predicting plasma transfusion (P < 0.001); MA was superior to platelet count for predicting platelet transfusion (P < 0.001); and LY-30 (rate of amplitude reduction 30 minutes after the MA is reached) documented fibrinolysis. These correlations improved for transfused, shocked or head injured patients. The charge for r-TEG ($317) was similar to the 5 CCTs ($286). CONCLUSIONS: The r-TEG data was clinically superior to results from 5 CCTs. In addition, r-TEG identified patients with an increased risk of early RBC, plasma and platelet transfusions, and fibrinolysis. Admission CCTs can be replaced with r-TEG.

Unique pattern of complications in elderly trauma patients at a Level I trauma center.

BACKGROUND: Trauma centers are caring for increased proportions of elderly patients. Although age and Injury Severity Score are independently associated with mortality, trauma centers were originally designed to care for seriously injured patients without age-specific guidelines. We hypothesized that elderly patients would have different complication patterns than their younger counterparts. METHODS: The trauma registry of an American College of Surgeons -verified Level I trauma center was queried for all patients older than 14 years admitted between January 2005 and December 2008. Mechanism, mortality, and complications were evaluated after dividing patients into eight age groups. RESULTS: Of the 15,223 patients, 13% were elderly (≥65), and 86% were injured via a blunt mechanism. Increasing age correlated with fatality (all Injury Severity Scores), end-organ failure, and thromboembolic complications (deep venous thrombosis and coagulopathy). Analysis revealed a significant breakpoint at 45 years of age for mortality, decubitus ulcer, and renal failure (all p values <0.05). Infectious complications (sepsis, wound infection, and abscess) all peaked between 45 years and 65 years and then declined with increasing age. CONCLUSIONS: We document that elderly trauma patients suffer the same complications as their younger counterparts, albeit at a different rate. More importantly, we identified a "breakpoint" of increased risk of complications and mortality at greater than 45 years. Although the mechanisms behind these observations remain unknown, understanding their unique patterns may allow appropriate allocation of resources and focus research efforts on interventions that should improve outcomes.

Damage control resuscitation is associated with a reduction in resuscitation volumes and improvement in survival in 390 damage control laparotomy patients.

OBJECTIVE: To determine whether implementation of damage control resuscitation (DCR) in patients undergoing damage control laparotomy (DCL) translates into improved survival. BACKGROUND: DCR aims at preventing coagulopathy through permissive hypotension, limiting crystalloids and delivering higher ratios of plasma and platelets. Previous work has focused only on the impact of delivering higher ratios (1:1:1). METHODS: A retrospective cohort study was performed on all DCL patients admitted between January 2004 and August 2010. Patients were divided into pre-DCR implementation and DCR groups and were excluded if they died before completion of the initial laparotomy. The lethal triad was defined as immediate postoperative temperature less than 95°F, international normalized ratio more than 1.5, or a pH less than 7.30. RESULTS: A total of 390 patients underwent DCL. Of these, 282 were pre-DCR and 108 were DCR. Groups were similar in demographics, injury severity, admission vitals, and laboratory values. DCR patients received less crystalloids (median: 14 L vs 5 L), red blood cells (13 U vs 7 U), plasma (11 U vs 8 U), and platelets (6 U vs 0 U) in 24 hours, all P < 0.05. DCR patients had less evidence of the lethal triad upon intensive care unit arrival (80% vs 46%, P < 0.001). 24-hour and 30-day survival was higher with DCR (88% vs 97%, P = 0.006 and 76% vs 86%, P = 0.03). Multivariate analysis controlling for age, injury severity, and emergency department variables, demonstrated DCR was associated with a significant increase in 30-day survival (OR: 2.5, 95% CI: 1.10-5.58, P = 0.028). CONCLUSION: In patients undergoing DCL, implementation of DCR reduces crystalloid and blood product administration. More importantly, DCR is associated with an improvement in 30-day survival.