rivaroxaban and Wounds-and-Injuries

This article emphasizes the differentiated management of direct oral anticoagulants (DOACs)-associated bleeding in trauma patients to generate a severity adjusted treatment protocol.. The management of DOAC-associated bleeding should take severity, mortality risk, and haemodynamic effects of the trauma-induced bleeding into account.. The different pharmacological properties of DOACs are important for the management of trauma-induced bleeding. Comorbidities like renal impairment and liver dysfunction prolong their half-life. Patients with minor bleeding in stable clinical condition can be managed by a 'wait and see' approach. Moderate bleeding is suggested to be managed by a primarily conservative approach. In life-threatening bleeding, the administration of activated or nonactivated factor concentrates seems justified, together with supportive measures as part of an advanced management protocol. The administration of specific antidotes may be an alternative in the future. A monoclonal antibody to dabigatran (idarucizumab) has recently been approved by the Food and Drug Administration, whereas antidotes to Factor X activated inhibitors (andexanet and aripazine) are still under development. Sufficiently powered studies with clinical and safety outcome measures are still missing for all specific antidotes at this time.

Topics: Administration, Oral; Antifibrinolytic Agents; Antithrombins; Atrial Fibrillation; Clinical Protocols; Dabigatran; Factor Xa Inhibitors; Hemorrhage; Humans; Plasma; Pyrazoles; Pyridines; Pyridones; Rivaroxaban; Thiazoles; United States; Wounds and Injuries

Topics: Anticoagulants; Antidotes; Benzimidazoles; beta-Alanine; Dabigatran; Emergencies; Humans; Morpholines; Pyrazoles; Pyridones; Rivaroxaban; Surgical Procedures, Operative; Thiophenes; Wounds and Injuries

Accurate medication reconciliation in trauma patients is essential but difficult. Currently, there is no established clinical method of detecting direct oral anticoagulants (DOACs) in trauma patients. We hypothesized that a liquid chromatography-mass spectrometry (LCMS)-based assay can be used to accurately detect DOACs in trauma patients upon hospital arrival.. Plasma samples were collected from 356 patients who provided informed consent including 10 healthy controls, 19 known positive or negative controls, and 327 trauma patients older than 65 years who were evaluated at our large, urban level 1 trauma center. The assay methodology was developed in healthy and known controls to detect apixaban, rivaroxaban, and dabigatran using LCMS and then applied to 327 samples from trauma patients. Standard medication reconciliation processes in the electronic medical record documenting DOAC usage were compared with LCMS results to determine overall accuracy, sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of the assay.. Of 356 patients, 39 (10.96%) were on DOACs: 21 were on apixaban, 14 on rivaroxaban, and 4 on dabigatran. The overall accuracy of the assay for detecting any DOAC was 98.60%, with a sensitivity of 94.87% and specificity of 99.05% (PPV, 92.50%; NPV, 99.37%). The assay detected apixaban with a sensitivity of 90.48% and specificity of 99.10% (PPV, 86.36%; NPV 99.40%). There were three false-positive results and two false-negative LCMS results for apixaban. Dabigatran and rivaroxaban were detected with 100% sensitivity and specificity.. This LCMS-based assay was highly accurate in detecting DOACs in trauma patients. Further studies need to confirm the clinical efficacy of this LCMS assay and its value for medication reconciliation in trauma patients.. Diagnostic Test, level III.

Topics: Administration, Oral; Aged; Anticoagulants; Chromatography, High Pressure Liquid; Dabigatran; Female; Healthy Volunteers; Humans; Male; Mass Spectrometry; Medication Reconciliation; Prospective Studies; Pyrazoles; Pyridones; Rivaroxaban; Sensitivity and Specificity; Wounds and Injuries

This study aims to compare the efficacy of enoxaparin, rivoraxaban and dabigatran on wound healing using a rat model.. Sprague-Dawley female rats (n=56), 10-12 weeks old, weight 245±30g, were used in this study. The rats were divided into four equally-sized groups. A type 1 (secondary wound healing) and type 2 (primary wound healing) wound was opened surgically on each rat in each group. Anticoagulent drugs enoxaparin, rivoraxaban and dabigatran and physiological saline solution were administered to Groups 1, 2, 3 and 4, respectively. After wound healing was scored tissue samples were taken from euthanised rats at days five and 10 and examined histologically. Since time was used as a classification (days five and 10), a time effect was included.. There was no statistically significant difference in total score distribution in rats between type 1 secondary wounds for days five and 10 (p>0.05). There was no statistically significant difference in the overall score distribution in rats between type 2 primary wounds for days five and 10 (p>0.05).. In addition to the use of low molecular weight heparin with well-known anticoagulation activity, the new generation oral medications are used efficiently in thromboembolic diseases. However, there was no evidence observed in this study that these drugs could be either beneficial or harmful to wound healing.

Topics: Administration, Cutaneous; Administration, Oral; Animals; Anticoagulants; Dabigatran; Enoxaparin; Female; Models, Animal; Random Allocation; Rats; Rats, Sprague-Dawley; Rivaroxaban; Saline Solution; Single-Blind Method; Skin; Treatment Outcome; Wound Healing; Wounds and Injuries

The safety and efficacy of nonvitamin K antagonist oral anticoagulants (NOACs) for the treatment of venous thromboembolism (VTE) have been established in randomized controlled trials, but limited data are available on their use in clinical practice across geographical regions.. In the international RE-COVERY DVT/PE observational study (enrollment January 2016 to May 2017), we sought to characterize the patient population and describe the prescribed anticoagulant. Patient characteristics and anticoagulants administered after objective diagnosis of VTE were recorded at the baseline visit and again at hospital discharge or at 14 days after the diagnosis, whichever was later.. A total of 6095 patients were included, 50.2% were male, and the mean age was 61.5 years. The most common comorbidities were hypertension (35%), diabetes mellitus (11%), cancer (11%), prior VTE(11%), and trauma/surgery (7%). Overall, 77% of patients received oral anticoagulants, with 54% on NOACs and 23% on vitamin K antagonists (VKAs); 20% received parenteral anticoagulation only. NOACs comprised about 60% of anticoagulant treatment in Europe and Asia but substantially less in Latin America (29%) and the Middle East (21%). For NOAC therapies, the distribution (as a percentage of the total cohort) was rivaroxaban 25.6%, dabigatran 15.5%, apixaban 11.3%, and edoxaban 1.7%. Treatment with NOACs was less frequent in patients who had cancer, chronic renal disease, heart failure, or stroke.. These findings enhance our understanding of baseline characteristics and the initial management of patients with VTE in routine practice.

Topics: Administration, Oral; Adult; Age Distribution; Aged; Anticoagulants; Asia; Comorbidity; Cross-Sectional Studies; Dabigatran; Diabetes Mellitus; Europe; Factor Xa Inhibitors; Female; Fondaparinux; Heparin; Humans; Hypertension; Latin America; Male; Middle Aged; Middle East; Neoplasms; Postoperative Complications; Practice Patterns, Physicians'; Pulmonary Embolism; Pyrazoles; Pyridines; Pyridones; Rivaroxaban; Thiazoles; Venous Thromboembolism; Venous Thrombosis; Wounds and Injuries

Venous thromboembolism (VTE) is a frequent and morbid complication after injury. Despite utilization of twice-daily enoxaparin, a significant proportion of patients still develop VTE. The purpose of this study was to compare the safety and efficacy of rivaroxaban to enoxaparin for the prevention of VTE in patients with multisystem injuries.. This retrospective cohort analysis evaluated VTE rate in multiply injured patients at a level I trauma Center. Propensity matching was used to compare patients receiving rivaroxaban or enoxaparin. The primary outcome was incidence of VTE during or up to 6 mo after admission. Secondary outcomes included major and minor bleeding, hospital mortality, and hospital length of stay.. A total of 2106 patients were randomly selected from the entire cohort for inclusion. Patients who developed a VTE with no significant difference between groups (14 [1.3%] in the rivaroxaban group and 14 [1.3%] in the enoxaparin group, P = 1) was 1.3%. In addition, there was no difference in deep venous thrombosis (10 [0.9%] in the rivaroxaban group and 12 [1.1%] in the enoxaparin group) or pulmonary embolism (6 [0.6%] in the rivaroxaban group and 2 [0.2%] in the enoxaparin group). Incidence of bleeding, minor or major, was equivalent between groups (P > 0.05). Hospital length of stay and mortality were significantly higher in the enoxaparin group compared with rivaroxaban (11 [1.0%] versus 0 [0%] respectively, P < 0.001).. Rivaroxaban demonstrated a similar incidence of VTE and bleeding complications as enoxaparin. Rivaroxaban may be a safe and effective alternative for VTE prophylaxis in this high-risk population.

Topics: Adult; Enoxaparin; Factor Xa Inhibitors; Female; Humans; Length of Stay; Male; Middle Aged; Retrospective Studies; Rivaroxaban; Venous Thromboembolism; Wounds and Injuries

Topics: Antidotes; Blood Coagulation Factors; Blood Component Transfusion; Blood Loss, Surgical; Cerebral Hemorrhage; Drug Administration Schedule; Emergencies; Factor Xa; Factor Xa Inhibitors; Hemorrhage; Humans; Intraoperative Care; Premedication; Preoperative Care; Pyrazoles; Pyridones; Recombinant Proteins; Rivaroxaban; Wounds and Injuries

The number of anticoagulated trauma patients is increasing. Trauma patients on warfarin have been found to have poor outcomes, particularly after intracranial hemorrhage (ICH). However, the effect of novel oral anticoagulants (NOAs) on trauma outcomes is unknown. We hypothesized that patients on NOAs would have higher rates of ICH, ICH progression, and death compared with patients on traditional anticoagulant and antiplatelet agents.. This was a prospective observational trial across 16 trauma centers. Inclusion criteria was any trauma patient admitted on aspirin, clopidogrel, warfarin, dabigatran, rivaroxaban, or apixaban. Demographic data, admission vital signs, mechanism of injury, injury severity scores, laboratory values, and interventions were collected. Outcomes included ICH, progression of ICH, and death.. A total of 1,847 patients were enrolled between July 2013 and June 2015. Mean age was 74.9 years (SD ± 13.8), 46% were female, 77% were non-Hispanic white. At least one comorbidity was reported in 94% of patients. Blunt trauma accounted for 99% of patients, and the median Injury Severity Score was 9 (interquartile range, 4-14). 50% of patients were on antiplatelet agents, 33% on warfarin, 10% on NOAs, and 7% on combination therapy or subcutaneous agents.Patients taking NOAs were not at higher risk for ICH on univariate (24% vs. 31%) or multivariate analysis (incidence rate ratio, 0.78; confidence interval 0.61-1.01, p = 0.05). Compared with all other agents, patients on aspirin (90%, 81 mg; 10%, 325 mg) had the highest rate (35%) and risk (incidence rate ratio, 1.27; confidence interval, 1.13-1.43; p < 0.001) of ICH. Progression of ICH occurred in 17% of patients and was not different between medication groups. Study mortality was 7% and was not significantly different between groups on univariate or multivariate analysis.. Patients on NOAs were not at higher risk for ICH, ICH progression, or death.. Prognostic/epidemiologic study, level III.

Topics: Administration, Oral; Aged; Anticoagulants; Aspirin; Clopidogrel; Dabigatran; Female; Humans; Injury Severity Score; Intracranial Hemorrhages; Male; Platelet Aggregation Inhibitors; Prospective Studies; Pyrazoles; Pyridones; Rivaroxaban; Ticlopidine; Trauma Centers; Warfarin; Wounds and Injuries; Wounds, Nonpenetrating

Here, we present the case of a patient with the findings of an early intracardiac thrombus and a pulmonary embolus after major trauma. A large clot was identified extending from the inferior vena cava into the right atrium and ventricle in the setting of preserved right ventricular function. Post-traumatic intracardiac thrombus is extremely rare and no comparable cases have previously been described in the absence of a congenital heart defect and obvious myocardial injury. Best practice afterpost-traumatic intracardiac thrombus is not well established but we found that early inferior vena cava filter placement and treatment with therapeutic coagulation resulted in clinical improvement, resolution of the thrombus and no further emboli. The successful use of rivaroxaban, a direct-acting oral anticoagulant, to treat a right heart thrombus has, to our knowledge, not previously been reported. Early acute traumatic coagulopathy has received much attention but the hypercoagulable state that often follows is less well appreciated.

Topics: Echocardiography; Factor Xa Inhibitors; Female; Heart Atria; Heart Diseases; Humans; Pulmonary Embolism; Rare Diseases; Rivaroxaban; Thromboembolism; Thrombosis; Treatment Outcome; Vena Cava Filters; Vena Cava, Inferior; Wounds and Injuries; Young Adult

Although anticoagulation with warfarin has been associated with increased risk of adverse outcomes after trauma, the effects of the new oral agents (NOA) such as dabigatran, apixaban, rivaroxaban are not yet well characterized.. A retrospective review of a level 1 trauma center database identified all patients aged ≥ 50 admitted after trauma during a 24 month period starting September 2013. Demographics, including preadmission anticoagulation agents, injuries, hospital course and outcomes were abstracted from the electronic medical record.. Over the 24-month period, 3,392 patients were admitted; 112 (3.3%) were anticoagulated with NOA and 373 (11.0%) with warfarin with a trend toward increasing utilization of the new agents compared with warfarin over that period. Although comparable in age, injury severity scores, and mechanism of injury, patients anticoagulated with warfarin had both a higher overall mortality (10.9%) compared with the NOA (6.25%) and the non-anticoagulated control (5.5%) groups (p < 0.001) as well as a higher trauma-related mortality (9.0%) versus NOA (2.8%) and control (3.7%) groups (p < 0.001). Patients on warfarin or NOA were admitted to intensive care unit or step down unit more frequently than control patients. (45.0% and 41.9% vs. 35.7% respectively; p < 0.001). The incidence of traumatic brain injury was similar among the three groups. Although it did not reach statistical significance, trauma-specific mortality in the traumatic brain injury subset was higher in the warfarin group (19.3%) than the NOA (16.7%) or control (10.9%) groups (p = 0.08). In a multivariable logistic regression, warfarin (odds ratio, 2.215; 95% confidence interval, 1.365-3.596; p = 0.001), but not the NOA (odds ratio, 0.871; 95% confidence interval, 0.258-2.939; p = 0.823), was an independent predictor for mortality.. Although the experience with the new oral anticoagulation agents is still limited, patients on these agents appear to have lower mortality after traumatic injury than patients on warfarin.. Epidemiologic study, level III.

Topics: Administration, Oral; Aged; Anticoagulants; Antithrombins; Connecticut; Dabigatran; Demography; Factor Xa Inhibitors; Female; Humans; Injury Severity Score; Male; Middle Aged; Pyrazoles; Pyridones; Retrospective Studies; Risk Factors; Rivaroxaban; Trauma Centers; Warfarin; Wounds and Injuries