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Eric J. Ley - One of the best experts on this subject based on the ideXlab platform.
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Trauma patients with lower extremity and pelvic fractures: Should anti-factor Xa Trough Level guide prophylactic enoxaparin dose?
International journal of surgery (London England), 2018Co-Authors: Navpreet K. Dhillon, Galinos Barmparas, Russell Mason, Bruce L. Gewertz, Eric J.t. Smith, Emma Gillette, Eric J. LeyAbstract:Abstract Background Adequate venous thromboembolism (VTE) prophylaxis is essential after trauma, especially in patients with lower extremity and/or pelvic fractures. We sought to investigate if prophylactic enoxaparin dosed by anti -Xa Trough Levels could reduce clinically evident VTE in trauma patients with lower extremity or pelvic injury. Methods Prospective data was collected on trauma patients admitted for at least two days with any lower extremity and/or pelvic fracture and who received enoxaparin for VTE prophylaxis between October 2013 and January 2016. Patients in the control cohort received enoxaparin at 30 mg twice daily. Patients in the adjustment cohort had anti -Xa Trough Levels measured after three or more consecutive doses of enoxaparin. Those with a Trough Level of 0.1 IU/mL or lower had their dosage increased by 10-mg increments. Results Of the 159 patients included, 58 (36.5%) were monitored with anti -Xa Trough Levels. The cohorts were similar in age, sex, regional AIS, ISS score, ICU and hospital length of stay, proportion of patients with diagnostic testing for VTE, and time to first enoxaparin dose. Initial enoxaparin dosing in the majority of patients (84.5%) who had anti -Xa Trough Levels measured was subprophylactic. Patients receiving enoxaparin dosed by anti -Xa Trough Level had a significantly lower VTE rate than those who did not (1.7% v. 13.9%, p = 0.03). Conclusions Prophylactic enoxaparin adjusted by anti -factor Xa Level may lead to a decreased rate of clinically evident VTE among trauma patients with lower extremity and/or pelvic fractures. Our findings indicate that the initial dose of enoxaparin was frequently too low.
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Association Between Enoxaparin Dosage Adjusted by Anti–Factor Xa Trough Level and Clinically Evident Venous Thromboembolism After Trauma
JAMA surgery, 2016Co-Authors: Megan Y. Harada, Galinos Barmparas, Kevin Chung, Russell Mason, Dorothy A. Yim, Navpreet K. Dhillon, Daniel R. Margulies, Bruce L. Gewertz, Eric J. LeyAbstract:Importance Trauma patients are at high risk for developing venous thromboembolism (VTE). The VTE rate when enoxaparin sodium is dosed by anti–factor Xa (anti-Xa) Trough Level is not well described. Objective To determine whether targeting a prophylactic anti-Xa Trough Level by adjusting the enoxaparin dose would reduce the VTE rate in trauma patients. Design, Setting, and Participants Single-institution, historic vs prospective cohort comparison study at an urban, academic, Level I trauma center. The prospective cohort was enrolled from August 2014 to May 2015 and compared with a historic cohort admitted from August 2013 to May 2014. Trauma patients who received enoxaparin adjusted by anti-Xa Trough Level (adjustment group) were compared with those who received enoxaparin sodium at a dosage of 30 mg twice daily (control group). Patients were excluded if they were younger than 18 years, had a length of hospital stay less than 2 days, or had preexisting deep vein thrombosis. Patients were excluded from the adjustment group for changes in the choice of thromboprophylaxis (heparin, enoxaparin once-daily dosing, early ambulation), hospital discharge before initial Trough Levels could be drawn, or incorrect timing of Trough Levels. Exposures Anti-Xa Trough Levels were monitored in patients in the adjustment group receiving 3 or more consecutive doses of enoxaparin sodium, 30 mg twice daily. Patients with a Trough Level of 0.1 IU/mL or lower received enoxaparin sodium increased by 10-mg increments. After providing 3 adjusted doses of enoxaparin, the Trough Level was redrawn and the dosage was adjusted as necessary. Patients in the control group received enoxaparin sodium at a dosage of 30 mg twice daily without adjustments. Main Outcomes and Measures Rates of symptomatic VTE (deep vein thrombosis and pulmonary embolism, confirmed by duplex ultrasonography and chest computed tomographic angiography, respectively) and bleeding risk. Results A total of 205 patients (mean [SD] age, 41.3 [18.2] years; 75.1% male) were studied, 87 in the adjustment group and 118 in the control group, with similar baseline characteristics and injury profiles. Subprophylactic anti-Xa Troughs were noted in 73 of 87 patients (83.9%) in the adjustment group, and the majority of patients (57 of 87 patients [65.5%]) required dosage adjustment of enoxaparin sodium to 40 mg twice daily. Incidence of VTE was significantly lower in the adjustment group than in the control group (1.1% vs 7.6%, respectively; P = .046). When the adjustment group was compared with the control group, no significant difference was noted in the rate of packed red blood cell transfusion (6.9% vs 12.7%, respectively; P = .18) or mean (SD) hematocrit at discharge (34.5% [6.3%] vs 33.4% [6.8%], respectively [to convert to proportion of 1.0, multiply by 0.01]; P = .19). Conclusions and Relevance In this study, subprophylactic anti-Xa Trough Levels were common in trauma patients. Enoxaparin dosage adjustment may lead to a reduced rate of VTE without an increased risk of bleeding.
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association between enoxaparin dosage adjusted by anti factor xa Trough Level and clinically evident venous thromboembolism after trauma
JAMA Surgery, 2016Co-Authors: Megan Y. Harada, Galinos Barmparas, Kevin Chung, Russell Mason, Dorothy A. Yim, Navpreet K. Dhillon, Daniel R. Margulies, Bruce L. Gewertz, Eric J. LeyAbstract:Importance Trauma patients are at high risk for developing venous thromboembolism (VTE). The VTE rate when enoxaparin sodium is dosed by anti–factor Xa (anti-Xa) Trough Level is not well described. Objective To determine whether targeting a prophylactic anti-Xa Trough Level by adjusting the enoxaparin dose would reduce the VTE rate in trauma patients. Design, Setting, and Participants Single-institution, historic vs prospective cohort comparison study at an urban, academic, Level I trauma center. The prospective cohort was enrolled from August 2014 to May 2015 and compared with a historic cohort admitted from August 2013 to May 2014. Trauma patients who received enoxaparin adjusted by anti-Xa Trough Level (adjustment group) were compared with those who received enoxaparin sodium at a dosage of 30 mg twice daily (control group). Patients were excluded if they were younger than 18 years, had a length of hospital stay less than 2 days, or had preexisting deep vein thrombosis. Patients were excluded from the adjustment group for changes in the choice of thromboprophylaxis (heparin, enoxaparin once-daily dosing, early ambulation), hospital discharge before initial Trough Levels could be drawn, or incorrect timing of Trough Levels. Exposures Anti-Xa Trough Levels were monitored in patients in the adjustment group receiving 3 or more consecutive doses of enoxaparin sodium, 30 mg twice daily. Patients with a Trough Level of 0.1 IU/mL or lower received enoxaparin sodium increased by 10-mg increments. After providing 3 adjusted doses of enoxaparin, the Trough Level was redrawn and the dosage was adjusted as necessary. Patients in the control group received enoxaparin sodium at a dosage of 30 mg twice daily without adjustments. Main Outcomes and Measures Rates of symptomatic VTE (deep vein thrombosis and pulmonary embolism, confirmed by duplex ultrasonography and chest computed tomographic angiography, respectively) and bleeding risk. Results A total of 205 patients (mean [SD] age, 41.3 [18.2] years; 75.1% male) were studied, 87 in the adjustment group and 118 in the control group, with similar baseline characteristics and injury profiles. Subprophylactic anti-Xa Troughs were noted in 73 of 87 patients (83.9%) in the adjustment group, and the majority of patients (57 of 87 patients [65.5%]) required dosage adjustment of enoxaparin sodium to 40 mg twice daily. Incidence of VTE was significantly lower in the adjustment group than in the control group (1.1% vs 7.6%, respectively; P = .046). When the adjustment group was compared with the control group, no significant difference was noted in the rate of packed red blood cell transfusion (6.9% vs 12.7%, respectively; P = .18) or mean (SD) hematocrit at discharge (34.5% [6.3%] vs 33.4% [6.8%], respectively [to convert to proportion of 1.0, multiply by 0.01]; P = .19). Conclusions and Relevance In this study, subprophylactic anti-Xa Trough Levels were common in trauma patients. Enoxaparin dosage adjustment may lead to a reduced rate of VTE without an increased risk of bleeding.
Lieven Pouillon - One of the best experts on this subject based on the ideXlab platform.
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Vedolizumab Trough Level monitoring in inflammatory bowel disease: a state-of-the-art overview
BMC medicine, 2019Co-Authors: Lieven Pouillon, Severine Vermeire, Peter BossuytAbstract:Therapeutic drug monitoring involves therapeutic modifications based on the measurement of drug Levels and antidrug antibodies. The viability of therapeutic drug monitoring in vedolizumab-treated patients with inflammatory bowel disease remains questioned. Accumulating evidence from clinical trials and real-world data suggests that an exposure–efficacy relationship may exist for vedolizumab in inflammatory bowel disease, but results are not as straightforward as they are for anti-tumour necrosis factor-α therapy. Robust target vedolizumab Trough Levels are currently missing, since available data are heterogenous and prospective, interventional pharmacokinetic–pharmacodynamic studies are lacking. The positioning of vedolizumab drug monitoring in therapeutic algorithms is yet to be defined. Therapeutic drug monitoring has the potential to improve the outcome parameters of vedolizumab-treated patients with inflammatory bowel disease. Before the therapeutic drug monitoring of vedolizumab can be implemented in a widespread fashion, prospective studies are needed to evaluate the effect of vedolizumab dose optimisation. These studies should focus on objective disease markers and vedolizumab drug Levels, and define thresholds for optimal drug exposure.
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Vedolizumab Trough Levels and Histological Healing During Maintenance Therapy in Ulcerative Colitis.
Journal of Crohn's & colitis, 2019Co-Authors: Lieven Pouillon, Silvio Danese, Camille Zallot, Hélène Rousseau, Hélène Busby-venner, Marcelo De Carvalho Bittencourt, Myriam Choukour, Guillaume Gauchotte, Cédric Baumann, Laurent Peyrin-birouletAbstract:BACKGROUND AND AIMS Histological healing may be the ultimate therapeutic goal in ulcerative colitis [UC]. We investigated, for the first time, the association between vedolizumab Trough Levels and histological healing in UC. METHODS This is a single-centre retrospective cohort study including all consecutive UC patients on vedolizumab maintenance therapy who had a histological evaluation blindly to clinical data and underwent therapeutic drug monitoring, between June 2014 and March 2018. Per-event analysis was performed. Histological healing was defined as a Nancy histological index ≤1. RESULTS Thirty-five histological samples were analysed. Median [interquartile range] vedolizumab Trough Levels were higher in the group with histological healing (31.5 [25-49.1] μg/mL) compared with the group without histological healing (15 [9-26.6] μg/mL, p = 0.02). The higher vedolizumab Trough Level quartiles tended to be associated with greater rates of histological healing [p = 0.10]. A cut-off vedolizumab Trough Level of 25 μg/mL predicted histological healing with an accuracy of 74% and an area under the receiver operating curve of 0.62 [95% confidence interval 0.58-0.92, p = 0.004]. Bivariate analysis identified a vedolizumab Trough Level ≥25 µg/mL [p = 0.006], a partial Mayo score ≤1 [p = 0.008], C-reactive protein Level
Laurent Peyrin-biroulet - One of the best experts on this subject based on the ideXlab platform.
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Vedolizumab Trough Levels and Histological Healing During Maintenance Therapy in Ulcerative Colitis.
Journal of Crohn's & colitis, 2019Co-Authors: Lieven Pouillon, Silvio Danese, Camille Zallot, Hélène Rousseau, Hélène Busby-venner, Marcelo De Carvalho Bittencourt, Myriam Choukour, Guillaume Gauchotte, Cédric Baumann, Laurent Peyrin-birouletAbstract:BACKGROUND AND AIMS Histological healing may be the ultimate therapeutic goal in ulcerative colitis [UC]. We investigated, for the first time, the association between vedolizumab Trough Levels and histological healing in UC. METHODS This is a single-centre retrospective cohort study including all consecutive UC patients on vedolizumab maintenance therapy who had a histological evaluation blindly to clinical data and underwent therapeutic drug monitoring, between June 2014 and March 2018. Per-event analysis was performed. Histological healing was defined as a Nancy histological index ≤1. RESULTS Thirty-five histological samples were analysed. Median [interquartile range] vedolizumab Trough Levels were higher in the group with histological healing (31.5 [25-49.1] μg/mL) compared with the group without histological healing (15 [9-26.6] μg/mL, p = 0.02). The higher vedolizumab Trough Level quartiles tended to be associated with greater rates of histological healing [p = 0.10]. A cut-off vedolizumab Trough Level of 25 μg/mL predicted histological healing with an accuracy of 74% and an area under the receiver operating curve of 0.62 [95% confidence interval 0.58-0.92, p = 0.004]. Bivariate analysis identified a vedolizumab Trough Level ≥25 µg/mL [p = 0.006], a partial Mayo score ≤1 [p = 0.008], C-reactive protein Level
Megan Y. Harada - One of the best experts on this subject based on the ideXlab platform.
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Association Between Enoxaparin Dosage Adjusted by Anti–Factor Xa Trough Level and Clinically Evident Venous Thromboembolism After Trauma
JAMA surgery, 2016Co-Authors: Megan Y. Harada, Galinos Barmparas, Kevin Chung, Russell Mason, Dorothy A. Yim, Navpreet K. Dhillon, Daniel R. Margulies, Bruce L. Gewertz, Eric J. LeyAbstract:Importance Trauma patients are at high risk for developing venous thromboembolism (VTE). The VTE rate when enoxaparin sodium is dosed by anti–factor Xa (anti-Xa) Trough Level is not well described. Objective To determine whether targeting a prophylactic anti-Xa Trough Level by adjusting the enoxaparin dose would reduce the VTE rate in trauma patients. Design, Setting, and Participants Single-institution, historic vs prospective cohort comparison study at an urban, academic, Level I trauma center. The prospective cohort was enrolled from August 2014 to May 2015 and compared with a historic cohort admitted from August 2013 to May 2014. Trauma patients who received enoxaparin adjusted by anti-Xa Trough Level (adjustment group) were compared with those who received enoxaparin sodium at a dosage of 30 mg twice daily (control group). Patients were excluded if they were younger than 18 years, had a length of hospital stay less than 2 days, or had preexisting deep vein thrombosis. Patients were excluded from the adjustment group for changes in the choice of thromboprophylaxis (heparin, enoxaparin once-daily dosing, early ambulation), hospital discharge before initial Trough Levels could be drawn, or incorrect timing of Trough Levels. Exposures Anti-Xa Trough Levels were monitored in patients in the adjustment group receiving 3 or more consecutive doses of enoxaparin sodium, 30 mg twice daily. Patients with a Trough Level of 0.1 IU/mL or lower received enoxaparin sodium increased by 10-mg increments. After providing 3 adjusted doses of enoxaparin, the Trough Level was redrawn and the dosage was adjusted as necessary. Patients in the control group received enoxaparin sodium at a dosage of 30 mg twice daily without adjustments. Main Outcomes and Measures Rates of symptomatic VTE (deep vein thrombosis and pulmonary embolism, confirmed by duplex ultrasonography and chest computed tomographic angiography, respectively) and bleeding risk. Results A total of 205 patients (mean [SD] age, 41.3 [18.2] years; 75.1% male) were studied, 87 in the adjustment group and 118 in the control group, with similar baseline characteristics and injury profiles. Subprophylactic anti-Xa Troughs were noted in 73 of 87 patients (83.9%) in the adjustment group, and the majority of patients (57 of 87 patients [65.5%]) required dosage adjustment of enoxaparin sodium to 40 mg twice daily. Incidence of VTE was significantly lower in the adjustment group than in the control group (1.1% vs 7.6%, respectively; P = .046). When the adjustment group was compared with the control group, no significant difference was noted in the rate of packed red blood cell transfusion (6.9% vs 12.7%, respectively; P = .18) or mean (SD) hematocrit at discharge (34.5% [6.3%] vs 33.4% [6.8%], respectively [to convert to proportion of 1.0, multiply by 0.01]; P = .19). Conclusions and Relevance In this study, subprophylactic anti-Xa Trough Levels were common in trauma patients. Enoxaparin dosage adjustment may lead to a reduced rate of VTE without an increased risk of bleeding.
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association between enoxaparin dosage adjusted by anti factor xa Trough Level and clinically evident venous thromboembolism after trauma
JAMA Surgery, 2016Co-Authors: Megan Y. Harada, Galinos Barmparas, Kevin Chung, Russell Mason, Dorothy A. Yim, Navpreet K. Dhillon, Daniel R. Margulies, Bruce L. Gewertz, Eric J. LeyAbstract:Importance Trauma patients are at high risk for developing venous thromboembolism (VTE). The VTE rate when enoxaparin sodium is dosed by anti–factor Xa (anti-Xa) Trough Level is not well described. Objective To determine whether targeting a prophylactic anti-Xa Trough Level by adjusting the enoxaparin dose would reduce the VTE rate in trauma patients. Design, Setting, and Participants Single-institution, historic vs prospective cohort comparison study at an urban, academic, Level I trauma center. The prospective cohort was enrolled from August 2014 to May 2015 and compared with a historic cohort admitted from August 2013 to May 2014. Trauma patients who received enoxaparin adjusted by anti-Xa Trough Level (adjustment group) were compared with those who received enoxaparin sodium at a dosage of 30 mg twice daily (control group). Patients were excluded if they were younger than 18 years, had a length of hospital stay less than 2 days, or had preexisting deep vein thrombosis. Patients were excluded from the adjustment group for changes in the choice of thromboprophylaxis (heparin, enoxaparin once-daily dosing, early ambulation), hospital discharge before initial Trough Levels could be drawn, or incorrect timing of Trough Levels. Exposures Anti-Xa Trough Levels were monitored in patients in the adjustment group receiving 3 or more consecutive doses of enoxaparin sodium, 30 mg twice daily. Patients with a Trough Level of 0.1 IU/mL or lower received enoxaparin sodium increased by 10-mg increments. After providing 3 adjusted doses of enoxaparin, the Trough Level was redrawn and the dosage was adjusted as necessary. Patients in the control group received enoxaparin sodium at a dosage of 30 mg twice daily without adjustments. Main Outcomes and Measures Rates of symptomatic VTE (deep vein thrombosis and pulmonary embolism, confirmed by duplex ultrasonography and chest computed tomographic angiography, respectively) and bleeding risk. Results A total of 205 patients (mean [SD] age, 41.3 [18.2] years; 75.1% male) were studied, 87 in the adjustment group and 118 in the control group, with similar baseline characteristics and injury profiles. Subprophylactic anti-Xa Troughs were noted in 73 of 87 patients (83.9%) in the adjustment group, and the majority of patients (57 of 87 patients [65.5%]) required dosage adjustment of enoxaparin sodium to 40 mg twice daily. Incidence of VTE was significantly lower in the adjustment group than in the control group (1.1% vs 7.6%, respectively; P = .046). When the adjustment group was compared with the control group, no significant difference was noted in the rate of packed red blood cell transfusion (6.9% vs 12.7%, respectively; P = .18) or mean (SD) hematocrit at discharge (34.5% [6.3%] vs 33.4% [6.8%], respectively [to convert to proportion of 1.0, multiply by 0.01]; P = .19). Conclusions and Relevance In this study, subprophylactic anti-Xa Trough Levels were common in trauma patients. Enoxaparin dosage adjustment may lead to a reduced rate of VTE without an increased risk of bleeding.
Navpreet K. Dhillon - One of the best experts on this subject based on the ideXlab platform.
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Trauma patients with lower extremity and pelvic fractures: Should anti-factor Xa Trough Level guide prophylactic enoxaparin dose?
International journal of surgery (London England), 2018Co-Authors: Navpreet K. Dhillon, Galinos Barmparas, Russell Mason, Bruce L. Gewertz, Eric J.t. Smith, Emma Gillette, Eric J. LeyAbstract:Abstract Background Adequate venous thromboembolism (VTE) prophylaxis is essential after trauma, especially in patients with lower extremity and/or pelvic fractures. We sought to investigate if prophylactic enoxaparin dosed by anti -Xa Trough Levels could reduce clinically evident VTE in trauma patients with lower extremity or pelvic injury. Methods Prospective data was collected on trauma patients admitted for at least two days with any lower extremity and/or pelvic fracture and who received enoxaparin for VTE prophylaxis between October 2013 and January 2016. Patients in the control cohort received enoxaparin at 30 mg twice daily. Patients in the adjustment cohort had anti -Xa Trough Levels measured after three or more consecutive doses of enoxaparin. Those with a Trough Level of 0.1 IU/mL or lower had their dosage increased by 10-mg increments. Results Of the 159 patients included, 58 (36.5%) were monitored with anti -Xa Trough Levels. The cohorts were similar in age, sex, regional AIS, ISS score, ICU and hospital length of stay, proportion of patients with diagnostic testing for VTE, and time to first enoxaparin dose. Initial enoxaparin dosing in the majority of patients (84.5%) who had anti -Xa Trough Levels measured was subprophylactic. Patients receiving enoxaparin dosed by anti -Xa Trough Level had a significantly lower VTE rate than those who did not (1.7% v. 13.9%, p = 0.03). Conclusions Prophylactic enoxaparin adjusted by anti -factor Xa Level may lead to a decreased rate of clinically evident VTE among trauma patients with lower extremity and/or pelvic fractures. Our findings indicate that the initial dose of enoxaparin was frequently too low.
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Association Between Enoxaparin Dosage Adjusted by Anti–Factor Xa Trough Level and Clinically Evident Venous Thromboembolism After Trauma
JAMA surgery, 2016Co-Authors: Megan Y. Harada, Galinos Barmparas, Kevin Chung, Russell Mason, Dorothy A. Yim, Navpreet K. Dhillon, Daniel R. Margulies, Bruce L. Gewertz, Eric J. LeyAbstract:Importance Trauma patients are at high risk for developing venous thromboembolism (VTE). The VTE rate when enoxaparin sodium is dosed by anti–factor Xa (anti-Xa) Trough Level is not well described. Objective To determine whether targeting a prophylactic anti-Xa Trough Level by adjusting the enoxaparin dose would reduce the VTE rate in trauma patients. Design, Setting, and Participants Single-institution, historic vs prospective cohort comparison study at an urban, academic, Level I trauma center. The prospective cohort was enrolled from August 2014 to May 2015 and compared with a historic cohort admitted from August 2013 to May 2014. Trauma patients who received enoxaparin adjusted by anti-Xa Trough Level (adjustment group) were compared with those who received enoxaparin sodium at a dosage of 30 mg twice daily (control group). Patients were excluded if they were younger than 18 years, had a length of hospital stay less than 2 days, or had preexisting deep vein thrombosis. Patients were excluded from the adjustment group for changes in the choice of thromboprophylaxis (heparin, enoxaparin once-daily dosing, early ambulation), hospital discharge before initial Trough Levels could be drawn, or incorrect timing of Trough Levels. Exposures Anti-Xa Trough Levels were monitored in patients in the adjustment group receiving 3 or more consecutive doses of enoxaparin sodium, 30 mg twice daily. Patients with a Trough Level of 0.1 IU/mL or lower received enoxaparin sodium increased by 10-mg increments. After providing 3 adjusted doses of enoxaparin, the Trough Level was redrawn and the dosage was adjusted as necessary. Patients in the control group received enoxaparin sodium at a dosage of 30 mg twice daily without adjustments. Main Outcomes and Measures Rates of symptomatic VTE (deep vein thrombosis and pulmonary embolism, confirmed by duplex ultrasonography and chest computed tomographic angiography, respectively) and bleeding risk. Results A total of 205 patients (mean [SD] age, 41.3 [18.2] years; 75.1% male) were studied, 87 in the adjustment group and 118 in the control group, with similar baseline characteristics and injury profiles. Subprophylactic anti-Xa Troughs were noted in 73 of 87 patients (83.9%) in the adjustment group, and the majority of patients (57 of 87 patients [65.5%]) required dosage adjustment of enoxaparin sodium to 40 mg twice daily. Incidence of VTE was significantly lower in the adjustment group than in the control group (1.1% vs 7.6%, respectively; P = .046). When the adjustment group was compared with the control group, no significant difference was noted in the rate of packed red blood cell transfusion (6.9% vs 12.7%, respectively; P = .18) or mean (SD) hematocrit at discharge (34.5% [6.3%] vs 33.4% [6.8%], respectively [to convert to proportion of 1.0, multiply by 0.01]; P = .19). Conclusions and Relevance In this study, subprophylactic anti-Xa Trough Levels were common in trauma patients. Enoxaparin dosage adjustment may lead to a reduced rate of VTE without an increased risk of bleeding.
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association between enoxaparin dosage adjusted by anti factor xa Trough Level and clinically evident venous thromboembolism after trauma
JAMA Surgery, 2016Co-Authors: Megan Y. Harada, Galinos Barmparas, Kevin Chung, Russell Mason, Dorothy A. Yim, Navpreet K. Dhillon, Daniel R. Margulies, Bruce L. Gewertz, Eric J. LeyAbstract:Importance Trauma patients are at high risk for developing venous thromboembolism (VTE). The VTE rate when enoxaparin sodium is dosed by anti–factor Xa (anti-Xa) Trough Level is not well described. Objective To determine whether targeting a prophylactic anti-Xa Trough Level by adjusting the enoxaparin dose would reduce the VTE rate in trauma patients. Design, Setting, and Participants Single-institution, historic vs prospective cohort comparison study at an urban, academic, Level I trauma center. The prospective cohort was enrolled from August 2014 to May 2015 and compared with a historic cohort admitted from August 2013 to May 2014. Trauma patients who received enoxaparin adjusted by anti-Xa Trough Level (adjustment group) were compared with those who received enoxaparin sodium at a dosage of 30 mg twice daily (control group). Patients were excluded if they were younger than 18 years, had a length of hospital stay less than 2 days, or had preexisting deep vein thrombosis. Patients were excluded from the adjustment group for changes in the choice of thromboprophylaxis (heparin, enoxaparin once-daily dosing, early ambulation), hospital discharge before initial Trough Levels could be drawn, or incorrect timing of Trough Levels. Exposures Anti-Xa Trough Levels were monitored in patients in the adjustment group receiving 3 or more consecutive doses of enoxaparin sodium, 30 mg twice daily. Patients with a Trough Level of 0.1 IU/mL or lower received enoxaparin sodium increased by 10-mg increments. After providing 3 adjusted doses of enoxaparin, the Trough Level was redrawn and the dosage was adjusted as necessary. Patients in the control group received enoxaparin sodium at a dosage of 30 mg twice daily without adjustments. Main Outcomes and Measures Rates of symptomatic VTE (deep vein thrombosis and pulmonary embolism, confirmed by duplex ultrasonography and chest computed tomographic angiography, respectively) and bleeding risk. Results A total of 205 patients (mean [SD] age, 41.3 [18.2] years; 75.1% male) were studied, 87 in the adjustment group and 118 in the control group, with similar baseline characteristics and injury profiles. Subprophylactic anti-Xa Troughs were noted in 73 of 87 patients (83.9%) in the adjustment group, and the majority of patients (57 of 87 patients [65.5%]) required dosage adjustment of enoxaparin sodium to 40 mg twice daily. Incidence of VTE was significantly lower in the adjustment group than in the control group (1.1% vs 7.6%, respectively; P = .046). When the adjustment group was compared with the control group, no significant difference was noted in the rate of packed red blood cell transfusion (6.9% vs 12.7%, respectively; P = .18) or mean (SD) hematocrit at discharge (34.5% [6.3%] vs 33.4% [6.8%], respectively [to convert to proportion of 1.0, multiply by 0.01]; P = .19). Conclusions and Relevance In this study, subprophylactic anti-Xa Trough Levels were common in trauma patients. Enoxaparin dosage adjustment may lead to a reduced rate of VTE without an increased risk of bleeding.
