Safety and efficacy of thromboelastography guidance of antifibrinolytic therapy in trauma patients: An observational cohort analysis.

BACKGROUND: Tranexamic acid (TXA) is an antifibrinolytic therapy intended to decrease blood loss and improve hemostasis in traumatic hemorrhage. Viscoelastic assays, such as thromboelastography (TEG), allow for the identification of a patient's specific hemostasis. The purpose of this research study was to explore the safety and efficacy of TEG-guided antifibrinolytic therapy in trauma patients. METHODS: This study was a retrospective review of trauma patients meeting institution-specific inclusion criteria for TXA. Patients were assigned to fibrinolytic groups per TEG LY30 data. Safety outcomes (24-h mortality, overall in-hospital mortality, and thromboembolic events) were compared between patients who did or did not receive TXA and within fibrinolytic groups. Mortality outcomes were adjusted for baseline Injury Severity Score (ISS). Secondary aims included blood product utilization, length of hospital, and intensive care unit stay. RESULTS: Hypofibrinolysis was the most common fibrinolytic phenotype. Adjusting for ISS, there were no significant differences in mortality. A 30.7% thromboembolism incidence was identified in the TXA group compared to 16.6% not receiving TXA (P = 0.26), with 72.7% of these patients experiencing fibrinolytic shutdown. CONCLUSIONS: There were no differences in 24-h mortality, all-cause mortality, or secondary outcomes. The difference in thromboembolic rates between patients receiving TXA and those who did not, while not statistically significant, poses clinical concern.

Enoxaparin Dosing for Venous Thromboembolism Prophylaxis in Low Body Weight Patients.

BACKGROUND: The appropriate dose of enoxaparin for venous thromboembolism (VTE) prophylaxis in low body weight patients is unknown. OBJECTIVE: The aim of this study is to evaluate the impact of enoxaparin dosing on major and minor bleeding events in low body weight patients. METHODS: This was a retrospective cohort study of patients weighing less than 45 kg receiving subcutaneous (SC) enoxaparin for VTE prevention. The primary objective was to determine whether enoxaparin dose was associated with major and minor bleeding. The secondary objective was to determine the incidence of VTE by enoxaparin dose. RESULTS: There were 173 patients included in the study, of which 37 patients received 2 different courses of enoxaparin during hospitalization, resulting in 210 enoxaparin courses. Among all enoxaparin courses, 16.2% were associated with major bleeding and 5.2% with minor bleeding. There was no difference in the incidence of major bleeding by dose (enoxaparin 30 mg SC daily, 30 mg SC twice daily, or 40 mg SC daily; P = .409). Patients who experienced major bleeding were older (54.9 ± 16.1 years) than patients who did not (48.4 ± 18.4 years) (P = .043). There was no difference in the incidence of minor bleeding by dosing schedule (P = .14). No patients experienced a VTE. CONCLUSION AND RELEVANCE: The risk of bleeding was similar by enoxaparin dose but increased with age in low body weight patients. Given the low incidence of VTE in this study, it is reasonable to consider decreasing the prophylactic enoxaparin dose in low body weight patients, especially in the elderly population.

Four-factor prothrombin complex concentrate for the reversal of factor Xa inhibitors for traumatic intracranial hemorrhage.

OBJECTIVE: The objective of this study was to determine the effectiveness and safety of four-factor prothrombin complex concentrate (4F-PCC) for the reversal of factor Xa inhibitors in patients with traumatic intracranial hemorrhage (ICH). METHODS: This was a retrospective cohort study of patients taking factor Xa inhibitors with traumatic ICH between March 1, 2015 and August 31, 2017 at two trauma centers. The primary outcome was in-hospital mortality in patients who received 4F-PCC (4F-PCC group) compared to those who did not (no reversal group). Secondary outcomes included functional recovery, hospital and intensive care unit (ICU) length of stay (LOS), and thromboembolic complications. RESULTS: There were 62 patients included in the study. Injury Severity Score (ISS) was significantly higher in the 4F-PCC group (17.6 vs. 12.1, p = 0.019). The 4F-PCC group had a significantly higher mortality (22.9% vs. 3.7%, p = 0.034) and longer ICU LOS (2.5 vs. 1.4 days, p = 0.0024). The no reversal group had a significantly higher incidence of ischemic stroke/transient ischemic attack (TIA) (0% vs. 14.8%, p = 0.019). After controlling for ISS, there was no significant difference in mortality (p = 0.20), ICU LOS (p = 0.64), or ischemic stroke/TIA (p = 0.94). There was no difference in hospital LOS, discharge disposition, final Activity Measure for Post Acute Care daily activity score, VTE, or MI. CONCLUSION: Patients with a higher ISS received 4F-PCC preferentially, which led to an apparent mortality benefit the no reversal group. After adjusting for baseline differences between groups, there was no difference in mortality, functional recovery, hospital and ICU LOS, or thromboembolic complications.

Look-alike medications: a formula for possible morbidity and mortality in the long-term care facility.

Medication errors remain an important cause of patient morbidity and mortality. Although all medications have the potential to induce unwanted adverse effects, data on the actual incidence and overall severity of preventable adverse drug reactions remains unknown. An Institute of Medicine report (Institute of Medicine. Preventing medication errors: Quality chasm series. Washington DC, National Academies Press. 2007-06-15) estimated that 1.5 million preventable adverse drug events occur annually in the US and that from 44,000 to 98,000 individuals die in hospitals annually from preventable medication errors. The types of medication errors of clinical relevance leading to moderate to severe outcomes are unfortunately numerous. Such errors would include wrong drug, wrong dose / wrong dose interval and represent the more serious form of a medication error. Institutionalized patients and those patients cared for in long-term care facilities appear to be at heightened risk for a medication error. These patients often receive multiple medications and suffer from variable degrees of cognitive impairment which complicates or negates patient-caregiver communication, one of the most important means to prevent medication errors. Moreover, the increasing financial constraints placed upon treatment facilities encourage the use of generic, rather than name brand medications by their pharmacy provider. While the use of bioequivalent generic medications is completely appropriate and can be very cost-effective, generic drug manufacturers are less often manufacturing their generic medications to look like the name brand drug. Rather, more and more generic medications are plain appearing with no resemblance whatsoever to the name brand product. This difference in drug appearance between the generic and the brand name product as well as differences in drug appearance between different generic drug manufacturers for the same medication represents another, important means by which patients may experience moderate to serious consequences from a medication error. We report such an experience where a patient in a long-term care facility received multi-day, excessive dosing of glipizide rather than her anti-spasticity medication, baclofen.