Pharmacokinetic model-guided enoxaparin dosing in the Neonatal ICU: Retrospective cohort study to plan for prospective feasibility trial.

Traditional milligram per kilogram (mg/kg) dosing of enoxaparin in neonates frequently fails to achieve target anti-Xa levels promptly, necessitating repeated laboratory monitoring and dose adjustments. This study investigated whether a personalized dosing strategy based on predicted individual clearance and volume of distribution could improve outcomes, comparing standard-of-care (SOC) mg/kg dosing to pharmacokinetic (PK) model-informed precision dosing (MIPD). A retrospective analysis was conducted on hospitalized neonates treated with enoxaparin at less than 44 weeks postmenstrual age from 2019 to 2022. Data on demographics, drug dosing, PK model covariates, and clinical outcomes were extracted from electronic health records and analyzed using the Pumas-AI Lyv dosing tool. The primary focus was on comparing the initial SOC dose to the MIPD-recommended dose. The secondary outcome measured was the time required to achieve therapeutic anti-Xa levels. The study included 168 neonates with a median postnatal age of 15 days (range 1-149) and a median dosing weight of 3.1 kg (range: 0.82-5.2). MIPD-recommended initial doses were 20%-60% higher than SOC doses in 32% of the cases and over 60% higher in 11% of cases. Neonates who received SOC doses that were much lower than the MIPD recommendation showed the longest delays in reaching therapeutic anti-Xa levels. The results indicate that PK model-informed of enoxaparin dosing leads to higher initial dosages than SOC in neonates, potentially reducing the time to therapeutic anti-Xa levels. These findings are being utilized to define dosing limits for a prospective trial of MIPD in neonatal intensive care settings.

Fondaparinux Sodium for Anticoagulant Therapy After Primary Percutaneous Coronary Intervention: A Single-Center Randomized Trial in China.

ABSTRACT: In this study, we investigated the safety and efficacy of fondaparinux sodium in postpercutaneous coronary intervention (PCI) anticoagulation therapy for patients with ST-segment elevation myocardial infarction. There are a total of 200 patients with ST segment elevation myocardial infarction underwent PCI and anticoagulation therapy. They were randomly split into experimental (n = 108) and control groups (n = 92). The experimental group received postoperative fondaparinux sodium (2.5 mg q.d), while the control group received enoxaparin (4000 IU q12 h). We did not use a loading dose for enoxaparin. Bleeding incidence and major adverse cardiovascular/cerebrovascular events were monitored during hospitalization, and at 1, 3, and 6 months postsurgery. The primary end points, including bleeding, mortality, and myocardial infarction during hospitalization, were not significantly different between the 2 groups. For secondary end points, the incidence of combined end point events at 1 month, 3 months, and 6 months after surgery in the experimental group was lower than in the control group (P < 0.05). According to Cox regression analysis, the risk of bleeding in the experimental group was significantly lower than that in the control group [hazard ratios: 0.506, 95% confidence interval (CI): 0.284-0.900] (P = 0.020). The risk of mortality in the experimental group was significantly lower than in the control group (hazard ratio: 0.188, 95% CI: 0.040-0.889) (P = 0.035). In summary, perioperative use of fondaparinux sodium during PCI in patients with STEMI in this study was associated with a lower risk of bleeding and death compared with enoxaparin use in the absence of loading dose.

Fondaparinux versus Enoxaparin in the Treatment of Obese Patients with Acute Coronary Syndrome. / Fondaparinux versus Enoxaparina no Tratamento de Pacientes Obesos com Síndrome Coronariana Aguda.

BACKGROUND: Fondaparinux is an effective and safe anticoagulant in the treatment of acute coronary syndromes (ACS). However, due to the low representation of obese individuals in clinical trials, the effects of applying the results of this drug to this population remain uncertain. OBJECTIVES: To compare Fondaparinux to Enoxaparin in the treatment of obese patients with ACS. METHODS: This is a retrospective cohort study, including obese individuals (BMI ≥ 30 Kg/m2) admitted with non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina (UA) and treated with Fondaparinux or Enoxaparin between 2010 and 2020. The Fondaparinux and Enoxaparin groups were compared for their clinical and laboratory characteristics using chi-square and Mann-Whitney tests, as appropriate. The incidence of primary outcomes (death, reinfarction, stroke, major bleeding) was compared between groups. P-value < 0.05 was considered significant for all analyses. RESULTS: A total of 367 obese patients with NSTEMI or UA were included, of whom 258 used Fondaparinux and 109 used Enoxaparin. Mean age was 64 ± 12 years, and 52.9% were male. The prevalence of diabetes, hypertension, dyslipidemia, prior coronary artery disease, prior stroke, and implementation of invasive strategy was similar between groups. The incidence of the primary outcome was 4.7% in the Fondaparinux group and 5.5% in the Enoxaparin group (p = 0.729). There was no difference between groups when analyzing the components of the primary outcome separately. CONCLUSION: In a sample of obese patients with NSTEMI or UA, there was no difference in the occurrence of the composite outcome (death, stroke, reinfarction, major bleeding) between patients who used Fondaparinux or Enoxaparin.

FUNDAMENTO: O fondaparinux é um anticoagulante eficaz e seguro usado no tratamento de síndromes coronarianas agudas (SCAs). No entanto, devido à baixa representatividade de indivíduos obesos em ensaios clínicos, os efeitos de se aplicar os resultados desse medicamento nesta população continuam incertos. OBJETIVOS: Comparar o fondaparinux à enoxaparina no tratamento de obesos com SCA. MÉTODOS: Este é um estudo do tipo coorte retrospectivo, incluindo indivíduos obesos (IMC ≥ 30 Kg/m2) internados com Infarto do Miocárdio sem Elevação do Segmento ST (IAMSSST) ou Angina Instável (AI) e tratados com fondaparinux ou enoxaparina entre 2010 e 2020. Os grupos que receberam fondaparinux e enoxaparina foram comparados quanto suas características clínicas e laboratoriais usando o teste do qui-quadrado e o teste de Mann-Whitney, conforme apropriado. A incidência dos desfechos primários (morte, reinfarto, acidente vascular cerebral, sangramento maior) foi comparada entre os grupos. Um p<0,05 foi considerado estatisticamente significativo em todas as análises. RESULTADOS: Um total de 367 pacientes obesos com IAMSSST ou AI foi incluído, dos quais 258 usaram fondaparinux e 109 usaram enoxaparina. A idade média foi 64 ± 12 anos, 52,9% eram do sexo masculino. A prevalência e diabetes, hipertensão, dislipidemia, doença arterial coronariana prévia, acidente vascular cerebral prévio, e implementação de estratégia invasiva foi similar entre os grupos. A incidência do desfecho primário foi 4,7% no grupo fondaparinux e 5,5% no grupo enoxaparina (p = 0,729). Não houve diferença entre os grupos quando os componentes do desfecho primário foram analisados separadamente. CONCLUSÃO: Em uma amostra de pacientes obesos com IAMSSST ou AI, não houve diferença na ocorrência do desfecho composto (morte, acidente vascular cerebral, reinfarto, sangramento maior) entre os pacientes que utilizaram fondaparinux ou enoxaparina.

Enoxaparin and Early Postoperative Tibial Nailing: Increased Nonunion Revision Rates.

OBJECTIVES: To determine the association between postoperative enoxaparin use and the risk of requiring surgery for nonunion in patients treated with intramedullary nailing for midshaft fractures of the tibia. DESIGN: Retrospective cohort analysis. SETTING: Data were sourced from the PearlDiver national database. PATIENT SELECTION CRITERIA: Patients were identified through the PearlDiver database by using Current Procedural Terminology and International Classification of Diseases (ICD-10) codes. Included patients had undergone intramedullary nailing for midshaft fractures of the tibia between 2015 and 2020 and subsequently underwent revision surgery due to nonunion. OUTCOME MEASURES AND COMPARISONS: The primary outcome measured in this study was the rate of nonunion following intramedullary nailing for the different types of tibial shaft fractures (closed, Type I/II open, Type III open). For each fracture subtype, the study compared nonunion rates between those who received enoxaparin in the postoperative period and those who did not receive enoxaparin at any time during the first 6 weeks postoperatively. Factors such as the timing and duration of enoxaparin therapy and demographic variables were also considered. RESULTS: The study included 16,986 patients, average age was 49.2 years (SD 17.3); 43.1% were female. Five hundred four patients required revision surgery for nonunion (3.4%). Among patients who did not receive enoxaparin, the nonunion rates were 1.6%, 3.9%, and 6.9% for closed, Type I/II open, and Type III open fractures, respectively. For patients who received enoxaparin within the first 2 weeks, the nonunion rates were 2.6%, 4.7%, and 7.9% for closed (RR = 1.67, P < 0.0001), Type I/II open (RR = 1.21, P < 0.0001), and Type III open (RR = 1.17, P = 0.355) fractures, respectively. Logistic regression confirmed enoxaparin was independently associated with nonunion (odds ratios [OR] = 1.75, P = 0.0013 for closed fractures; OR = 1.51, P = 0.034 for Type I/II open fractures). Tobacco use was also a contributing factor (OR = 2.43, P < 0.0001 for closed fractures; OR = 2.00, P < 0.0001 for Type I/II open fractures; OR = 2.04, P = 0.0008 for Type III open fractures). CONCLUSIONS: The postoperative use of enoxaparin was associated with an elevated risk of nonunion in patients treated with intramedullary nailing for fractures of the tibial shaft. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Heritable Thrombophilia and Increased Risk for Venous Thromboembolism Despite Thromboprophylaxis After Pelvis or Acetabulum Fracture.

OBJECTIVES: Individuals with pelvic and acetabular fractures are at high risk of venous thromboembolism (VTE). The purpose of this study was to determine whether serum markers for thrombophilia and rapid thromboelastography (r-TEG) values correlate with increased VTE risk among patients with pelvic and acetabular fractures. METHODS: . DESIGN: Prospective observational study. SETTING: Two urban academic level 1 trauma centers. PATIENT SELECTION CRITERIA: Adult patients with isolated pelvis and/or acetabulum fractures (OTA/AO 61 and 62) treated surgically placed on a standardized VTE chemoprophylaxis regimen with enoxaparin over a 5-year period were included. OUTCOME MEASURES AND COMPARISONS: Serum r-TEG, coagulation laboratory values, and markers for heritable thrombophilia were drawn postoperatively and after completion of a 6-week course of enoxaparin. The primary outcome was VTE event (either deep venous thrombosis or pulmonary embolism) diagnosed using a Duplex ultrasound, chest computed tomography angiogram, or lung ventilation-perfusion ordered based on clinical suspicion of a VTE event. Laboratory markers and values were then compared between patients who went on to have a VTE event and those who did not and patients with and without markers of thrombophilia. RESULTS: One hundred thirty-three adult patients with isolated operative pelvic and/or acetabular fractures were enrolled in this study. The average age of patients at time of injury was 48.3 years (range 18-91). Sixty-seven percent of patients in the study were (n = 90) males. Sixty-three percent of patients (n = 84) completed both clinical and laboratory follow-up. Forty-one percent of patients (n = 54) had 1 or more markers of heritable thrombophilia. Twelve percent (n = 10) of patients who completed follow-up were diagnosed with VTE. Age, sex, and smoking status were not associated with VTE. Patients who developed VTE had a higher body mass index (P = 0.04). Having more than 1 marker of heritable thrombophilia (P = 0.004) and an r-TEG mean amplitude greater than 72 mm postoperatively was positively associated with VTE (P = 0.02). CONCLUSIONS: Among patients treated surgically for isolated pelvic and acetabular fractures who received enoxaparin prophylaxis, the presence of more than 1 marker of heritable thrombophilia or r-TEG mean amplitude value greater than 72 mm postoperatively was associated with an increased risk of VTE. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Development of mucoadhesive 3D-printed Carbopol/Eudragit/SNAC tablets for the oral delivery of enoxaparin: In vitro and ex vivo evaluation.

3D-printed dosage forms comprised of Carbopol and Eudragit were fabricated through semi-solid extrusion, combining Enoxaparin (Enox) and the permeation enhancer SNAC in a single-step process without subsequent post-processing. Inks were characterized using rheology and Fourier-transform infrared (FTIR) spectroscopy. The stability of Enox in the fabricated dosage forms was assessed by means of Nuclear Magnetic Resonance (NMR) and Circular Dichroism (CD) analysis. In vitro release studies revealed the release of Enox in a sustained manner, whereas ex vivo experiments demonstrated the mucoadhesive properties of the 3D-printed dosage forms and their ability to enhance Enox permeability across intestinal mucosa. Cellular assays (CCK-8 assay) revealed a dose- and time-dependent response following incubation with the 3D-printed dosage forms. The encapsulation of SNAC in the 3D-printed dosage forms demonstrated their capacity to increase the transcellularly transport of macromolecule across Caco-2 monolayer in a reversible manner, as confirmed by Transepithelial Resistance (TEER) measurements.

Antithrombotic prophylaxis following total knee arthroplasty: a level I Bayesian network meta-analysis.

INTRODUCTION: Venous thromboembolism (VTE) is a major concern following total knee arthroplasty (TKA). The optimal pharmacological prophylaxis remains, however, controversial. The present investigation compared several non-vitamin K antagonist oral anticoagulants commonly employed as VTE prophylaxis following TKA. A Bayesian network meta-analysis was conducted to compare apixaban, aspirin, dabigatran, edoxaban, enoxaparin, fondaparinux, and rivaroxaban. The outcomes of interest were to compare the rate of deep venous thrombosis (DVT), pulmonary embolism (PE), and major and minor haemorrhages. METHODS: This study was conducted according to the PRISMA Extension Statement for Reporting of Systematic Reviews Incorporating Network Meta-Analyses of Health Care Interventions. In March 2024, PubMed, Web of Science, and Google Scholar were accessed with no time constraints. All randomised controlled trials (RCTs) comparing two or more drugs for the prevention of VTE following TKA were considered for inclusion. RESULTS: Data from 29,678 patients were collected. Of them, 67% (19,884 of 29,678 patients) were women. The mean age of the patients was 66.8 ± 2.8 years, and the mean BMI was 29.2 ± 1.5 kg/m2. There was comparability in age, sex, and BMI at baseline. Apixaban 5 mg, dabigatran 220 mg, and rivaroxaban 10 mg were the most effective in reducing the rate of DVT. Apixaban 5 mg, enoxaparin 60 mg, and rivaroxaban 40 mg were the most effective in reducing the rate of PE. Apixaban 5 mg, rivaroxaban 10 mg, and apixaban 10 mg were associated with the lowest rate of major haemorrhages. Apixaban 5 mg and 20 mg, and dabigatran 220 mg were associated with the lowest rate of minor haemorrhages. CONCLUSION: Administration of apixaban 5 mg demonstrated the best balance between VTE prevention and haemorrhage control following TKA. LEVEL OF EVIDENCE: Level I, network meta-analysis of RCTs.

Venous Thromboembolism Rates in Trauma Patients Significantly Increase With Missed Prophylactic Enoxaparin Doses.

Background: Current literature demonstrates prophylactic enoxaparin to be efficacious in reducing venous thromboembolism (VTE) rates without significantly increasing risk for bleeding complications. Despite this evidence, prophylactic enoxaparin doses are frequently withheld for surgery or procedures. This exploratory study aims to quantify the risk of a VTE event in trauma patients associated with missed doses of prophylactic enoxaparin. Methods: This retrospective cohort study evaluated trauma patients admitted to our Level 1 trauma center from January 1, 2012 to January 31, 2021. A 1:1 propensity match with ten variables was performed to compare patients receiving prophylactic enoxaparin that had a VTE and those that did not. The primary outcome was a VTE event. Results: 493 patients met inclusion criteria; 1:1 propensity score matching was performed resulting in a cohort of 184 patients. The percentage of patients that missed a prophylactic enoxaparin dose in the VTE group was higher than the no VTE group (34.8% vs 21.7%, P = 0.049). This is consistent when examining total missed doses (P = 0.038) and consecutively missed doses (P = 0.035). The odds of having a VTE for patients that missed at least one dose or more of enoxaparin are nearly two times greater (OR 1.92, 95% CI 0.997, 3.7). Conclusion: Missing enoxaparin doses significantly increases the risk of VTE in matched populations. Most prophylactic enoxaparin doses were held for procedures, and not for bleeding events. Trauma teams should carefully weigh the risk of bleeding complications associated with continuing enoxaparin prophylaxis against the significant thromboembolic risk of withholding it.

Avoiding the needle: A quality improvement program introducing apixaban for extended thromboprophylaxis after major gynecologic cancer surgery.

OBJECTIVE: Patients undergoing gynecologic cancer surgery at our centre are recommended up to 28 days of enoxaparin for extended post-operative thromboprophylaxis (EP). Baseline survey revealed 92% patient adherence, but highlighted negative effects on patient experience due to the injectable route of administration. We aimed to improve patient experience by reducing pain and bruising by 50%, increasing adherence by 5%, and reducing out-of-pocket cost after introducing apixaban as an oral alternative for EP. METHODS: In this interrupted time series quality improvement study, gynecologic cancer patients were offered a choice between apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously once daily) at time of discharge. A multidisciplinary team informed project design, implementation, and evaluation. Process interventions included standardized orders, patient and care team education programs. Telephone survey at 1 and 6 weeks and chart audit informed outcome, process, and balancing measures. RESULTS: From August to October 2022, 127 consecutive patients were included. Apixaban was chosen by 84%. Survey response rate was 74%. Patients who chose apixaban reported significantly reduced pain, bruising, increased confidence with administration, and less negative impact of the medication (p < 0.0001 for all). Adherence was unchanged (92%). The proportion of patients paying less than $125 (apixaban cost threshold) increased from 45% to 91%. There was no difference in bleeding and no VTE events. CONCLUSIONS: Introduction of apixaban for EP was associated with significant improvement in patient-reported quality measures and reduced financial toxicity with no effect on adherence or balancing measures. Apixaban is the preferred anticoagulant for EP at our centre.

Characterizing Enoxaparin's Population Pharmacokinetics to Guide Dose Individualization in the Pediatric Population.

BACKGROUND AND OBJECTIVE: Pediatric dosing of enoxaparin was derived based on extrapolation of the adult therapeutic range to children. However, a large fraction of children do not achieve therapeutic anticoagulation with initial dosing. We aim to use real-world anti-Xa data obtained from children receiving enoxaparin per standard of care to characterize the population pharmacokinetics (PopPK).Author names: Please confirm if the author names are presented accurately and in the correct sequence (given name, middle name/initial, family name). Also, kindly confirm the details in the metadata are correct.The author names are accurately presented and the metadata are correct.  METHODS: A PopPK analysis was performed using NONMEM, and a stepwise covariate modeling approach was applied for the covariate selection. The final PopPK model, developed with data from 1293 patients ranging in age from 1 day to 18 years, was used to simulate enoxaparin subcutaneous dosing for prophylaxis and treatment based on total body weight (0-18 years, TBW) or fat-free mass (2-18 years, FFM). Simulated exposures in children with obesity (body mass index percentile ≥95th percentile) were compared with those without obesity. RESULTS: A linear, one-compartment PopPK model that included allometric scaling using TBW (<2 years) or FFM (≥2 years) characterized the enoxaparin pharmacokinetic data. In addition, serum creatinine was identified as a significant covariate influencing clearance. Simulations indicated that in patients aged <2 years, the recommended 1.5 mg/kg TBW-based dosing achieves therapeutic simulated concentrations. In pediatric patients aged ≥2 years, the recommended 1.0 mg/kg dose resulted in exposures more comparable in children with and without obesity when FFM weight-based dosing was applied. CONCLUSION: Using real-world data and PopPK modeling, enoxaparin's pharmacokinetics were characterized in pediatric patients. Using FFM and twice-daily dosing might reduce the risk of overdosing, especially in children with obesity.

Unraveling Postoperative Bleeding Dynamics in Laparoscopic Roux-en-Y Gastric Bypass: Insights from a Single-Center Tranexamic Acid Study.

BACKGROUND: The efficacy of postoperative tranexamic acid (TXA) administration in mitigating bleeding after primary laparoscopic Roux-en-Y gastric bypass (RYGB), a prevalent complication associated with significant morbidities and mortality, and the use of sequential laboratory parameter changes in bleeding screening and TXA impact tracking were investigated. METHODS: This retrospective analysis included RYGB patients (aged 18-65 years, with a body mass index of 35-50 kg/m2) over 5 years who were categorized into three groups by evolving treatment regimens: Group A (n = 42) received standard pre- and postoperative enoxaparin (30 mg) every 12 h; Group B (n = 160) received enoxaparin and postoperative TXA (250 mg every 6 h); and Group C (n = 73) received TXA alone. Postoperative bleeding-related adverse events, vital signs, and laboratory changes were compared. RESULTS: Postoperative hemorrhage occurred in 3.6% (10/275) of patients, with no significant intergroup differences. Patients who experienced bleeding had greater decreases in hemoglobin (∆Hb) (2.1 vs. 1.4; p = 0.003), greater ∆Hb > 2 (50% vs. 15%; p = 0.013), and greater use of staples than did those who did not experience bleeding (8 vs. 7; p = 0.001). The ∆Hb values were lower in Groups B (1.4) and C (1.3) than in Group A (1.7, p = 0.011). No significant difference was noted between Groups C and B. CONCLUSION: This study emphasizes the potential of TXA to mitigate postoperative bleeding after RYGB, with no added benefit from excluding enoxaparin. Monitoring patients with a ∆Hb > 2 mg/dl and increased stapler usage is crucial. Further research is needed to validate routine TXA use across different procedures.

Investigation of the effects of treatment with enoxaparin sodium and hyperbaric oxygen therapy on the recovery of rats with achilles tendon rupture.

PURPOSE: In this study, we aimed to investigate the effects of hyperbaric oxygen therapy and enoxaparin sodium, which are known to accelerate bone tissue healing as well as tendon and soft tissue healing, on the healing of Achilles tendon rupture. METHODS: Thirty-six rats were used in the present study. All rats were divided into groups of nine. The groups were the enoxaparin sodium group, enoxaparin sodium and hyperbaric oxygen group, hyperbaric oxygen group and control group. After 21 days, the process was completed, and the rats were sacrificed. Achilles tendon samples were evaluated histopathologically. RESULTS: The groups were compared according to the results of statistical analysis based on the histopathological data. There was no significant difference between the groups in terms of acute inflammation (p = 0.785) or chronic inflammation (p = 0.827) scores, but there were significant differences in neovascularization (p = 0.009), proliferation (p < 0.001) and fibrosis (p = 0.006) scores. CONCLUSION: Our study showed that the use of enoxaparin sodium and hyperbaric oxygen had a positive effect on the healing of the Achilles tendon. Based on these results, we believe that the use of enoxaparin sodium and hyperbaric oxygen therapy after Achilles tendon rupture will be beneficial for healing and preventing complications.

A More Selective vs a Standard Risk-Stratified, Heparin-Based, Obstetric Thromboprophylaxis Protocol.

Importance: In 2016, our institution adopted a pregnancy-related venous thromboembolism (VTE) prophylaxis protocol based on American College of Obstetricians and Gynecologists guidelines that recommended postpartum heparin-based chemoprophylaxis (enoxaparin) based on a risk-stratified algorithm. In response to increased wound hematomas without significant reduction in VTE using this protocol, a more selective risk-stratified approach was adopted in 2021. Objective: To evaluate outcomes of the more selective risk-stratified approach to heparin-based obstetric thromboprophylaxis (enoxaparin) protocol. Design, Setting, and Participants: Retrospective observational study of 17 489 patients who delivered at a single tertiary care center in the southeast US between January 1, 2016, and December 31, 2018 (original protocol), and between December 1, 2021, and May 31, 2023 (more selective protocol). Patients receiving outpatient anticoagulation for active VTE or high VTE risk during pregnancy were excluded. Exposure: Standard risk-stratified and more selective postpartum VTE chemoprophylaxis protocols. Main Outcomes and Measures: The primary outcome was clinical diagnosis of wound hematoma up to 6 weeks pos tpartum. The secondary outcome was new diagnosis of VTE up to 6 weeks post partum. We compared baseline characteristics and outcomes between groups and estimated adjusted odds ratios with 95% CIs of primary and secondary outcomes using the original protocol group as reference. Results: Of 17 489 patients included in the analysis, 12 430 (71%) were in the original protocol group and 5029 (29%) were in the more selective group. Rates of chemoprophylaxis decreased from 16% (original protocol) to 8% (more selective protocol). Patients in the more selective group were more likely to be older, be married, and have obesity or other comorbidities (hypertension, diabetes, cardiac disease). Compared with the original protocol, the more selective protocol was associated with a decrease in any wound hematoma (0.7% vs 0.3%; adjusted odds ratio [aOR], 0.38; 95% CI, 0.21-0.67), specifically due to a lower rate of superficial wound hematomas (0.6% vs 0.3%; aOR, 0.43; 95% CI, 0.24-0.75). There was no significant increase in VTE or individual types of VTE (0.1% vs 0.1%; aOR, 0.40; 95% CI, 0.12-1.36). Conclusions and Relevance: A more selective risk-stratified approach to an enoxaparin thromboprophylaxis protocol for VTE was associated with decreased rates of wound hematomas without increased rates of postpartum VTE.

Hyperbaric oxygen treatment in bilateral orchiopexy and post-circumcision haematoma in a thrombocytopenic patient with Noonan syndrome.

Hyperbaric oxygen treatment (HBOT) can be utilised for necrotising soft tissue infections, clostridial myonecrosis (gas gangrene), crush injuries, acute traumatic ischaemia, delayed wound healing, and compromised skin grafts. Our case was a 17-month-old male patient with Noonan syndrome, idiopathic thrombocytopenic purpura, and bilateral undescended testicles. Haematoma and oedema developed in the scrotum and penis the day after bilateral orchiopexy and circumcision. Ischaemic appearances were observed on the penile and scrotal skin on the second postoperative day. Enoxaparin sodium and fresh frozen plasma were started on the recommendation of haematology. Hyperbaric oxygen treatment was initiated considering the possibility of tissue necrosis. We observed rapid healing within five days. We present this case to emphasise that HBOT may be considered as an additional treatment option in patients with similar conditions. To our knowledge, no similar cases have been reported in the literature.

Pulmonary venous thrombosis in a healthy pregnancy.

We describe an unusual case of bilateral pulmonary venous thrombosis in a pregnant woman in her mid 30s, who presented at 34 weeks of gestation with symptoms of sudden onset chest pain, shortness of breath and near syncope attacks. The patient was treated with enoxaparin and made an excellent clinical and hemodynamic recovery.

Patient-reported barriers for adherence to prophylactic enoxaparin after orthopedic trauma surgery.

INTRODUCTION: Venous thromboembolism following orthopedic trauma surgery remains prevalent despite prophylaxis being a standard of care. Enoxaparin injection is a commonly utilized prophylaxis regimen among high-risk patients. Patient-reported rates of nonadherence and barriers to enoxaparin use are not described in the literature. A better understanding of these barriers and their impact on adherence to post-discharge prophylaxis regimens may shed light on persistent outcomes gaps. MATERIALS AND METHODS: Semi-structured interviews were administered to adult patients prescribed prophylactic enoxaparin and presenting to orthopedic surgery outpatient clinic at an urban level 1 trauma center for a post-operative appointment following traumatic injury from April to July 2023. Patients self-reported their age, gender, race, and mobility. Inductive thematic analysis with three-reviewer consensus identified common barriers among responses. Adherence rates were calculated by dividing patients' estimated number of missed doses over total prescribed doses at the point of inquiry. RESULTS: We identified 154 eligible patients through chart review, and 50 enrolled and interviewed. Participants had a mean age of 37 years. Of 50 participants, 20 identified as female; 25 identified as Black or African American, 16 as White, 5 as Hispanic, 2 as Asian, and 2 as multiracial. Twenty-one participants were non-ambulatory at time of interview. Mean and median patient-reported adherence were 64.5 % (SD 35.5) and 70.5 % (IQR 33-100) respectively. Five patients reported complete nonadherence, while 17 patients reported perfect adherence. Every participant reporting complete nonadherence identified as Black or African American, as compared to 8 out of 17 reporting perfect adherence. Despite acknowledging a twice-daily prescription, 17 patients reported once-daily rather than twice-daily use. Inductive thematic analysis revealed the following six barriers to prophylaxis adherence (number of participants reporting): Inconvenience (18 patients), Pain (16), Fear (12), Acquisition (7), Bruising (7), and Mechanism (7). Altogether, 40 patients endorsed at least one barrier to adherence. DISCUSSION & CONCLUSIONS: Most patients face barriers to adherence with post-discharge prophylactic enoxaparin, and the resultant rates of adherence are low. This may contribute to persistent outcomes gaps in the orthopedic trauma population despite prophylaxis standards. Changes in prescribing patterns and patient engagement techniques may improve post-operative thromboembolic outcomes.

Enoxaparin Effect on Interleukin-10 Levels in Iraqi Patients with COVID-19: A Case-Control Study.

BACKGROUND: Coronavirus disease 19 (COVID-19), an infectious disease resulting from a virus known as severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), was discovered in China in 2019 and causes several mild to moderate respiratory conditions. This study aimed to reveal the changes in serum interleukin-10 (IL-10) and other parameters in Iraqi COVID-19 patients compared with healthy controls by studying the effects of enoxaparin and evaluating the potential of IL-10 as a disease activity marker. METHODS: This was a case-control study that included 180 samples: 90 patients hospitalized with COVID-19 from November 2022 to 20 April 2023 (40 patients had never used enoxaparin, whereas 50 patients had taken enoxaparin) and 90 healthy, age- and sex-matched control. There were 44 female patients and 46 male patients. The mean age of the patients and controls was 53.8 years vs. 50.8 years, respectively. The sandwich enzyme-linked immunosorbent assay (ELISA) method was used to measure IL-10 levels, while other parameters were assessed using the colorimetric method. RESULTS: The results of the study indicated highly significant changes between the patients and healthy controls in IL-10, D-dimer, and C-reactive protein (CRP) levels, as well as liver and renal functions. These findings elucidated a significant change between enoxaparin patients and non-enoxaparin patients in IL-10, D-dimer, and CRP levels. However, the liver and renal functions were not significantly altered. The Spearman's rank correlation test investigated the relationship between serum IL-10 and CRP. CONCLUSIONS: The results displayed a strong positive relationship between IL-10 and CRP. There were no significant differences between the other analyzed parameters; consequently, the patients had higher concentrations of IL-10, D-dimer, and some other parameters than the healthy controls. Additionally, IL-10 may be used as a marker of disease activity. Enoxaparin will likely help control IL-10 and D-dimer concentrations in patients since IL-10 levels decreased in patients treated with enoxaparin.

Effect of Enoxaparin on D-dimer levels in hospitalized Corona Virus patients with a comparison of its level in patients with comorbid conditions.

OBJECTIVE: Aim: The main goal is to assess the levels of comorbid diseases and examine the changes in D-dimer in hospitalized patients before and following SC enoxaparin medication. PATIENTS AND METHODS: Material and Methods: At the Al-Yarmouk Teaching Hospital in Baghdad, Iraq, from October 2022 to May 2023, 86 patients who were hospitalized and had severe to critical COVID-19 infections provided data for a retrospective analysis. RESULTS: Results: The medical records of all COVID-19 patients who were hospitalized and whose D-dimer level was greater than 0.5 mg/l and who were given enoxaparin (40 mg subcutaneously) were reviewed with the requisite authorization from the relevant authorities. The D-dimer level was assessed following therapy on the day of admission and day five after commencing enoxaparin. An examination of 86 case records revealed that persons with COVID-19 had significantly decreased D-dimer levels after taking subcutaneous enoxaparin (p-value<0.0001). The comorbidities (diabetes mellitus, hypertension) of patients who received the drug were compared. CONCLUSION: Conclusions: Enoxaparin and other anticoagulants were utilized to treat the coagulopathy brought on by COVID-19. Low molecular weight heparin enoxaparin has demonstrated positive outcomes in the management of VTE. A decrease in D-dimer level is anticipated when COVID-19 patients are treated with subcutaneous enoxaparin, partly because decreased coagulation results in lower fibrin formation.

Efficacy and Safety of Rivaroxaban Versus Enoxaparin in Prevention of Recurrence of Venous Thrombo-Embolism Events in Cancer Patients: A Meta-Analysis.

OBJECTIVE: To examine the effectiveness of rivaroxaban compared to enoxaparin in patients diagnosed with cancer and venous thromboembolism. METHODS: A search of Pub Med, Scopus, and Google Scholar, from inception through April 2023 was conducted. Articles comparing rivaroxaban with enoxaparin in patients with cancer and VTE/PE/DVT were included. Review Manager Version 5.2 was utilised for the analysis of the following outcomes; VTE, PE, DVT, major bleeding, and mortality. RESULTS: A total of 8 articles and 2276 patients were included in the final analysis. Pooled analysis showed that rivaroxaban had a statistically insignificant reduced association with VTE occurrence (RR:0.83, 95% CI:0.58-1.18, P:0.3) as well as a statically insignificant reduction in major bleeding (RR:0.79, 95% CI:0.53-1.18, P:0.25). Analysis showcased that there was an insignificant reduction of mortality rivaroxaban as compared to enoxaparin (RR:0.74, 95% CI: 0.46-1.20, P:0.23). CONCLUSION: Rivaroxaban can serve as a viable alternative to enoxaparin, with no appreciable drawbacks, for preventing and managing VTE in patients with malignancy.

The effects of enoxaparin treatment in a xenograft mouse model of oral squamous cell carcinoma: A pilot study.

BACKGROUND: Recent studies suggest that enoxaparin may have therapeutic effects on oral squamous cell carcinoma. We aimed to assess this effect utilizing xenograft mouse model through evaluations of proliferation and angiogenesis markers at the RNA and protein levels. METHODS: Mice were divided into enoxaparin treatment (n = 4), positive control (n = 4) and negative control (n = 3) groups. Immunohistochemical analyses were performed utilizing Bcl-2, Bax and Ki-67 antibodies. Expression levels of proliferation and apoptosis related genes were calculated utilizing qRT-PCR. Time-dependent proliferation assays were performed in OSC-19 and HEK293 cell-lines. RESULTS: Bax antibody showed positive staining in the cytoplasm and nuclei of tumor cells, while Bcl-2 antibody displayed staining only in the cytoplasm. A proliferation index of 15%-20% was found in all groups with the Ki-67 marker indicating no metastasis. Enoxaparin treatment caused decrease in BCL2, BAX and CCNB1 genes' expressions. Compared to HEK293, proliferation assays demonstrated higher division rates in OSC-19 with a significant decrease in viability after 96 h. CONCLUSION: Reduced BCL-2 expression indicates a regression of tumor growth, but reduced BAX expression is not correlated with increased apoptosis. Despite the aggressive nature of OSC-19, our results showed a low cell viability with a high division rate when compared with the control HEK293. This paralleled our in vivo findings that showed absence of lymph node metastasis across all mice groups. This discrepancy with the literature suggests that further investigations of the underlying mechanisms and protein-level analyses are needed to draw definitive conclusions about the effect of enoxaparin on OSC-19 behavior.