Whole Blood Program: Implementation in a Rural Trauma Center.

BACKGROUND: The balanced transfusion of blood components plays a leading role in traumatic hemostatic resuscitation. Yet, previous whole blood studies have only focused on urban trauma center settings. OBJECTIVE: To compare component vs whole blood therapy on wastage rates and mortality in the rural setting. METHODS: This study was a nonrandomized, retrospective, observational, single-center study on a cold-stored whole blood program implementation for adult massive transfusions from 2020 to 2022 at a Level II trauma center. Trauma registry data determined the facility's whole blood needs and facilitated sustainable blood supplies. Whole blood use protocols were established, and utilization and laboratory compliance for incompatible ABO antibody hemolysis was monitored and reviewed monthly at stakeholder and trauma services meetings. RESULTS: From 2018 to 2019, the facility initiated component therapy massive transfusions every 9 days (n = 41). Therefore, four units of low-titer, O-positive whole blood delivered fortnightly was determined to provide patient coverage and minimize wastage. Across the study time frame (2020-2022), there were n = 68 hemodynamically unstable patients, consisting of those receiving whole blood, n = 37, and patients receiving component therapy, n = 31. Mortality rates were significantly lower (p = .030) in the whole blood population (n = 3, 8%) compared to those solely receiving component therapy (n = 9, 29%). Wastage rates were constantly evaluated; in 2021, 43.4% was not utilized, and in 2022, this was reduced to 38.7%. Anecdotally, nurses appreciated the ease of administration and documentation of transfusing whole blood, as it negated ratio compliance. CONCLUSION: This evidence-based whole blood program provides vital care to severely injured trauma patients in a vast, rural region.

The Montana Interfacility Blood Network: A Novel Lifesaving "Hand-off" for the Optimal Care of Rural Patients.

Purpose: The state of Montana encompasses and defines rural health care as it is known in the United States (US) today. This vast area is punctuated by pockets of health care availability with varying access to blood products for transfusion. Furthermore, timely transport is frequently challenged by weather that may limit air transportation options, resulting in multiple hours in ground transport to definitive care. Patients and Methods: The Montana State Trauma Care Committee (MT-STCC) developed the Montana Interfacility Blood Network (MT-IBN) to ensure blood availability in geographically distanced cases where patients may otherwise not survive. The index case that led to the formal development of the MT-IBN is described, followed by a second case illustrating the IBN process. Results: This process and development manuscript details the innovative efforts of MT-STCC to develop this fledgling idea unique to rural US health care. We review guidelines that have been developed to define broad aspects of the MT-IBN including the reason to share resources, proper packaging, paperwork necessary for transfer, and how to provide resources directly to the patient. Finally, we describe implementation within the state. Conclusion: The MT-IBN was developed by MT-STCC to facilitate the hand-off of lifesaving blood to patients being transported by ground to definitive care in Montana without having to stop at an intermediary facility. This has already led to lives saved in areas that are limited in blood availability due to rurality.

Outcomes in necrotizing soft tissue infections are worse in rural versus urban Montana: a 10-year single center retrospective review.

Time to definitive surgical debridement has been recognized as a predictor for morbidity and mortality in necrotizing soft-tissue infections (NSTI). Rural patients are at particular risk due to limited local resources, decreased access to care, and prolonged transport times. The aim of the current study was to examine the outcomes of NSTI requiring surgical treatment in a previously non-described setting. This retrospective study (2010-2020) from a single tertiary care center in Montana reviewed patients ≥18 years old with a NSTI via ICD9/10 codes. Rural-Urban Continuum Codes (RUCC; characterizing counties by population size) were used to distinguish urban versus rural counties. Race (White and American Indian/Alaskan Native (AI/AN)) was self-described. Qualitative and quantitative comparisons between groups were determined using the appropriate two-tailed statistical tests. An aggregate of 177 patients was identified. Mean age in AI/AN was significantly lower (P<0.0001) compared to White patients with no preexisting condition delineation. NSTI demonstrated an elevated incidence in both rural areas and AI/AN patients. Diabetes was also significantly higher (P=0.0073) in rural versus urban patients. Both rural and AI/AN patients faced extended travel distance for treatment. AI/AN patients had a significantly different infection location than White. Furthermore, polymicrobial species were significantly more prevalent in AI/AN patients. Morbidities (defined as septic shock and/or amputation) were significantly higher in AI/AN patients and rural environments (P<0.01). There was no significant difference in all-cause mortality between respective groups. The state of Montana presents unique challenges to optimizing NSTI treatment due to excessive distances to regional tertiary care facilities. This delay in treatment can lead to increased morbidity.

A retrospective comparison of the emergent use of fixed-dose four-factor prothrombin complex versus weight-based dosing for intracranial hemorrhage assessing medication delivery time and cost.

OBJECTIVES: The goal of this study was to evaluate a low fixed-dose versus weight-based dosing strategy for four-factor prothrombin complex (4F-PCC) time to administration in intracranial hemorrhage (ICH) patients. METHODS: A retrospective analysis was conducted at a single rural Tertiary referral center in patients ≥18 years old on warfarin with ICH who received 4F-PCC. Continuous variables were summarized using mean (±95% CI) and compared using two-tailed tests; p values ≤0.05 were considered statistically significant. RESULTS: A total of 46 ICH patients were reversed using 4F-PCC (Fixed, n = 27 and Weight, n = 19). Baseline characteristics were equivalent. Total units of 4F-PCC (mean dose units 2525.1 versus 1623.3) and dose per kg were significantly reduced in the fixed-dose group. Total time from order to delivery was significantly reduced with the fixed-dose strategy (mean time 43.0 versus 29.0 minutes). Hospital length of stay (LOS), intensive care unit LOS, and mortality were equivalent with a similar mechanism. International Normalized Ratio (INR) reversal success (≤1.5) and total INR change was comparable with no difference in adverse thromboses between groups. CONCLUSIONS: A fixed-dosed strategy reduced time to 4F-PCC administration for warfarin reversal in ICH, as compared to a weight-based strategy; with no increase in LOS, mortality, or need for additional dosing. This also resulted in significant cost savings.

Malignancy does not dictate the hypercoagulable state following liver resection.

BACKGROUND: A hypercoagulable state following intra-abdominal malignant resections has been reported. Whether this is because of the operation or the malignancy, a known cause of hypercoagulability, remains unclear. We determined if malignancy status affected the coagulation profile following liver resection by assessing perioperative thromboelastogram (TEG) values. METHODS: Retrospective review of prospectively collected TEG values in patients who received a liver resection was conducted. Values among patients with benign or malignant disease were compared. RESULTS: Fourteen and 63 patients were resected for benign and malignant disease, respectively. No significant differences in TEG values existed between the groups. Combining the groups, patients developed a relative hypercoagulable state postoperatively with decreased R-times (P < .05), although median values remained within the normal range. CONCLUSION: Following liver resection, no differences in TEG values existed between patients with benign and malignant disease; the relative hypercoagulable state is more likely driven by postoperative coagulopathy rather than the malignancy status of the patient.

The international normalized ratio overestimates coagulopathy in patients after major hepatectomy.

BACKGROUND: The International Normalized Ratio (INR) is commonly used to guide therapy after hepatectomy. We hypothesized that the use of thrombelastography (TEG) would demonstrate a decreased incidence of hypocoagulability in this patient population. METHODS: Seventy-eight patients were prospectively enrolled before undergoing hepatectomy. INR, TEG, and coagulation factors were drawn before incision, postoperatively, and on postoperative days 1, 3, and 5. RESULTS: Patients demonstrated an elevated INR at all postoperative time points. However, TEG demonstrated a decreased R value postoperatively, with subsequent normalization. Other TEG measurements were equivalent to preoperative values. All procoagulant factors save factor VIII decreased postoperatively, with a simultaneous decrease in protein C. CONCLUSIONS: TEG demonstrated a brief hypercoagulable state after major hepatectomy, with coagulation subsequently normalizing. The INR significantly overestimates hypocoagulability after hepatectomy and these data call into question current practices using the INR to guide therapy in this patient population.

Correlation of missed doses of enoxaparin with increased incidence of deep vein thrombosis in trauma and general surgery patients.

IMPORTANCE: Enoxaparin sodium is widely used for deep vein thrombosis (DVT) prophylaxis, yet DVT rates remain high in the trauma and general surgery populations. Missed doses during hospitalization are common. OBJECTIVE: To determine if missed doses of enoxaparin correlate with DVT formation. DESIGN, SETTING, AND PARTICIPANTS: Data were prospectively collected among 202 trauma and general surgery patients admitted to a level I trauma center. MAIN OUTCOMES AND MEASURES: Deep vein thrombosis screening was performed using a rigorous standardized protocol. RESULTS: The overall incidence of DVT was 15.8%. In total, 58.9% of patients missed at least 1 dose of enoxaparin. The DVTs occurred in 23.5% of patients who missed at least 1 dose and in 4.8% of patients who did not (P < .01). On univariate analysis, the need for mechanical ventilation (71.8% vs 44.1%), the performance of more than 1 operation (59.3% vs 40.0%), and male sex (75% vs 56%) were associated with DVT formation (P < .05 for all). A bivariate logistic regression was then performed, which revealed age 50 years or older and interrupted enoxaparin therapy as the only independent risk factors for DVT formation. The DVT rate did not differ between trauma and general surgery populations or in patients receiving once-daily vs twice-daily dosing regimens. CONCLUSIONS AND RELEVANCE: Interrupted enoxaparin therapy and age 50 years or older are associated with DVT formation among trauma and general surgery patients. Missed doses occur commonly and are the only identified risk factor for DVT that can be ameliorated by physicians. Efforts to minimize interrupted enoxaparin prophylaxis in patients at risk for DVT should be optimized.

Thromboelastogram-guided enoxaparin dosing does not confer protection from deep venous thrombosis: a randomized controlled pilot trial.

BACKGROUND: The incidence of deep venous thrombosis (DVT) remains high in general surgery and trauma patients despite widespread prophylaxis with enoxaparin. A recent study demonstrated decreased incidence of DVT if patients on enoxaparin had a change in R time (ΔR) of greater than 1 minute when heparinase-activated thromboelastography (TEG) was compared with normal TEG. We hypothesized that using ΔR-guided dosing would result in decreased DVT rates. METHODS: A prospective, randomized controlled trial was performed at a Level 1 trauma center. Both trauma and general surgery patients were included. Upon enrollment, demographic data including age, sex, body mass index, and Acute Physiology and Chronic Health Evaluation II score were obtained. Enrolled patients were randomized to standard (30 mg twice a day) or TEG-guided dosing. Dose-adjusted patients underwent daily enoxaparin titration to achieve an ΔR of 1 minute to 2 minutes. Venous thromboembolism screening was performed per institutional protocol. Antithrombin III (AT-III) and anti-Xa levels were drawn at peak enoxaparin concentrations. RESULTS: A total of 87 patients were enrolled. There was no difference in demographic data between the groups. No pulmonary emboli were identified. The control group had a DVT rate of 16%, while the experimental group had a rate of 14% (p = nonsignificant). The experimental group's median enoxaparin dosage, 50 mg twice a day, was significantly higher than that of the control (p < 0.01). TEG ΔR was not different between the control and experimental groups. Beginning at Day 3, anti-Xa levels were higher in the experimental group (p < 0.05). There was no difference in AT-III activity between the two groups; 67% of the patients demonstrated AT-III deficiency. CONCLUSION: TEG adjusted enoxaparin dosing led to significant increases in anti-Xa activity, which did not correlate with a decreased DVT rate. Failure to reduce the DVT rate and increase ΔR despite increased dosing and increased anti-Xa activity is consistent with the high rate of AT-III deficiency detected in this study cohort. These data suggest that the future of DVT prevention may not lie in the optimization of low molecular weight heparin therapy but rather in compounds that increase antithrombin directly or operate independently of the AT-III pathway. LEVEL OF EVIDENCE: Therapeutic study, level III.

Uncontrolled hemorrhagic shock results in a hypercoagulable state modulated by initial fluid resuscitation regimens.

BACKGROUND: Previous studies have shown large-volume resuscitation modulates coagulopathy and inflammation. Our objective was to analyze the effects of initial bolus fluids used in military and civilian settings on coagulation and inflammation in a prospective, randomized, blinded trial of resuscitation of uncontrolled hemorrhage. METHODS: Fifty swine were anesthetized, intubated, and ventilated and had monitoring lines placed. A Grade V liver injury was performed followed by 30 minutes of hemorrhage. After 30 minutes, the liver was packed, and randomized fluid resuscitation was initiated during a 12-minute period with 2 L of normal saline, 2 L of lactated Ringer's solution, 250 mL of 7.5% saline with 3% Dextran, 500 mL of Hextend, or no fluid (NF). Animals were monitored for 2 hours after injury. Thrombelastograms (TEGs), prothrombin time (PT), partial thromboplastin time, fibrinogen as well as serum interleukin 6, interleukin 8, and tumor necrosis factor α levels were drawn at baseline and after 1 hour and 2 hours. RESULTS: The NF group had less posttreatment blood loss compared with other groups (p < 0.01). Blood loss was similar in the other groups. TEG R values in each group decreased from baseline at 1 and 2 hours (p < 0.02). The groups receiving 2 L of normal saline, 250 mL of 7.5% saline with 3% Dextran, or 500 mL of Hextend had lower TEG maximum amplitude values compared with NF group (p < 0.02). All fluids except lactated Ringer's solution resulted in significant increases in PT compared with NF, whereas all fluids resulted in significant decreases in fibrinogen compared with NF (p < 0.02). Fluid resuscitation groups as well as NF group demonstrated significant increases in inflammatory cytokines from baseline to 1 hour and baseline to 2 hours. There were no significant differences in inflammatory cytokines between groups at 2 hours. CONCLUSION: Withholding fluid resulted in the least significant change in PT, fibrinogen, and maximum amplitude and in the lowest posttreatment blood loss. Resuscitation with different initial fluid resuscitation strategies did not result in increased proinflammatory mediators compared with animals that did not receive fluid.