Dose Of Enoxaparin Research Articles

Evaluation of the Safety and Efficacy of Enoxaparin Once-Daily Versus Twice-Daily Dosing for Prophylaxis in Pediatric Patients.

Enoxaparin for the prevention of venous thromboembolism (VTE) in pediatric patients is -typically dosed twice a day. The use of once-daily dosing like that used in adult patients is limited because of a lack of safety and efficacy data. The aim of this study was to evaluate the safety and efficacy of -once-daily versus twice-daily dosing of enoxaparin for pediatric VTE prophylaxis based on incidence of thrombotic and bleeding events. This was a 3-year retrospective chart review of enoxaparin received for VTE prophylaxis at -Cohen Children's Medical Center, New Hyde Park, NY. Exclusion criteria were age 18 years or older, and renal dysfunction. A total of 177 enoxaparin courses (81 in the once-daily and 96 in the twice-daily group) were included. The median dose in the once-daily group was 0.68 mg/kg/dose with dose capping at 40 mg/dose in 70% of patients. One patient in the once-daily group had a VTE, whereas no patients in the twice-daily group experienced a VTE. One major bleeding event occurred in the once-daily group (p = 0.46); however, minor bleeding events were comparable between the 2 groups (p = 0.69). Once-daily enoxaparin prophylaxis appears to be safe and effective based on minimal -differences in incidence of thrombotic and bleeding events when compared to twice-daily dosing. Based on this study, it may be reasonable to consider once-daily enoxaparin dosing for prophylaxis, especially in older children. A larger multicenter cohort study evaluating once-daily dosing for prophylaxis is warranted to validate the safety and efficacy specifically for risk-based dosing strategies.

‘Door-to-prophylaxis’ as a novel quality improvement metric in prevention of venous thromboembolism following traumatic injury

ObjectiveVenous thromboembolism (VTE) risk reduction strategies include early initiation of chemoprophylaxis, reducing missed doses, weight-based dosing and dose adjustment using anti-Xa levels. We hypothesized that time to initiation of chemoprophylaxis...

Prophylactic Enoxaparin Dosing Using Anti-Factor Xa Levels in Hepatic Surgery Patients: A Pilot Study.

This study examines the safety and efficacy of using peak anti-Xa levels to achieve prophylactic enoxaparin (Lovenox, Sanofi-Aventis) levels in patients who underwent hepatic surgery. Prospectively enrolled patients undergoing major and minor hepatic procedures received postoperative enoxaparin dosing. The enoxaparin dose was adjusted to attain a peak anti-Xa level ≥ 0.20U/ml. This group was compared to a historical cohort of patients who underwent similar procedures and received standard postoperative VTE chemoprophylaxis dosing. Inpatient postoperative VTE rates were higher in the control group when compared to the experimental group (0 patients [0.00%] vs 4 patients [8.16%]; P = .035). There was no statistically significant difference in number of postoperative blood transfusions, discharge hemoglobin, or in-hospital bleeding events. Adjusting enoxaparin dosing to achieve prophylactic peak anti-Xa levels of ≥0.20IU/ml was associated with a reduced incidence of symptomatic inpatient postoperative VTE in patients who underwent hepatic surgery without increasing postoperative bleeding events.

Enoxaparin thromboprophylaxis in hospitalized obese pediatric patients.

Enoxaparin is an anticoagulant used for pharmacologic thromboprophylaxis in pediatrics. Enoxaparin pharmacokinetics can be altered in the setting of obesity. Optimal enoxaparin dosing for thromboprophylaxis in children with obesity remains unclear. A retrospective review was conducted of pediatric patients who weighed ≥60kg with BMI≥95th percentile, received enoxaparin for thromboprophylaxis, and had at least one appropriately drawn anti-factor Xa(anti-Xa) from 2013 to 2022. Anti-Xa levels were reviewed for patients initially treated with enoxaparin 30mg every 12h. The average daily enoxaparin dose required to achieve an anti-Xa of 0.2-0.4 unit/mL, which was stratified by BMI percentile and weight, was calculated. Of 116 patients (median age 15.8 years) included for analysis, 106 patients were initially treated with enoxaparin 30mg every 12h. Anti-Xa levels were<0.2 unit/mL in 53% of patients with BMI>99th percentile and 54% of patients>100kg. Ninety-one patients had at least one anti-Xa 0.2-0.4unit/mL with an average daily enoxaparin dosing of 66mg. When stratified by severity of obesity, higher doses were required to attain an anti-Xa 0.2-0.4 unit/mL in patients with BMI>99th percentile compared with those with 95th-99th percentile (67.8±15.7 vs. 62±5.6mg/day, p=.01). Patients>100kg required significantly higher dose than those ≤100kg (69.1±15.5 vs 61.2±7.3mg/day, p=.002). Increased initial dosing and/or anti-Xa level monitoring should be considered in adolescents with severe obesity receiving enoxaparin thromboprophylaxis.

Comparison of enoxaparin 40 mg versus 60 mg dosage for venous thromboprophylaxis in patients undergoing bariatric surgery: A randomized controlled trial

BackgroundVenous thromboembolism (VTE) is a common cause of morbidity and mortality after bariatric surgery. Morbid obesity is an independent risk factor for VTE, with goals of prophylactic anti-factor Xa levels within 0.2–0.5 IU/mL. The recommended dosing regimen of enoxaparin for VTE prophylaxis in patients with morbid obesity is lacking in available guidelines. ObjectivesTo evaluate the achieving prophylactic anti-factor Xa levels with different dosages of enoxaparin for morbid obesity patients. SettingWe conducted a study at Chulalongkorn Bariatric and Metabolic Institute, King Chulalongkorn Memorial Hospital. MethodsWe conducted a randomized controlled trial comparing anti-factor Xa levels 4 h after the administration of enoxaparin. All recruited patients randomly received 40 mg or 60 mg of enoxaparin 12 h before the operation. Blood specimens were collected 4 h after the administration of enoxaparin. ResultsIn total, 56 patients who presented between April 2019 and March 2020 at King Chulalongkorn Memorial Hospital were recruited. Of these patients, 28 received 40 mg and 28 received 60 mg of enoxaparin. In both groups, the rates of achieving target levels were 53.57% and 78.57%, respectively (p-value = 0.048). The mean anti-factor Xa levels were 0.19 IU/mL ± 0.06 IU/mL and 0.28 and 0.28 ± 0.10 IU/mL, respectively (p < 0.001). No significant difference was found in the estimated blood loss between the groups. No patient obtained anti-factor Xa levels exceeding 0.5 IU/mL. In both groups, no symptomatic VTE occurred. ConclusionsA 60 mg of enoxaparin regimen achieved more prophylactic anti-factor Xa levels than 40 mg in obese patients undergoing bariatric surgery without any adverse events.

Inadequate Anti–Factor Xa Levels With Daily 40-mg Enoxaparin After Cardiac Surgery

BackgroundCardiac surgery patients are at increased risk for venous thromboembolism (VTE). Prevention is the most critical strategy to reduce VTE-associated morbidity and death. However, there is a lack of data on the optimal approach to VTE prophylaxis in this population of high-risk patients. This study aimed to assess whether the standard dose of enoxaparin, the subcutaneous injection of 40 mg of enoxaparin daily, achieves adequate anti–factor Xa (aFXa) levels for VTE prophylaxis in patients after open heart surgery. MethodsAll patients with open heart surgery with cardiopulmonary bypass from August to December 2022 who received at least 3 consecutive doses of subcutaneously administered enoxaparin were included in the study. Patients receiving therapeutic anticoagulation, patients who underwent cardiac transplantation or placement of ventricular assist device, and patients with renal insufficiency were excluded. Serum aFXa was measured 0.5 to 1 hour before the fourth dose to attain the steady-state trough levels. ResultsData were completed for 44 patients. The target aFXa level was between 0.10 and 0.20 IU/mL for the avoidance of both underanticoagulation (≤0.10 IU/mL) and overanticoagulation (>0.20 IU/mL). The mean was 0.049 IU/mL with SD of 0.026 IU/mL, which was statistically significantly lower than the lower end of the target aFXa values (0.10 IU/mL; t43 = −13; P < .001; d = −1.9; 99% CI, −0.059 to −0.043). ConclusionsThe daily subcutaneous administration of 40 mg of enoxaparin leads to subprophylactic aFXa levels for most patients who undergo cardiac surgery. Further studies on the clinical relevance are warranted.

Inadequate prophylaxis in patients with trauma: anti-Xa-guided enoxaparin dosing management in critically ill patients with trauma

IntroductionVenous thromboembolism (VTE) causes significant morbidity in patients with trauma despite advances in pharmacologic therapy. Prior literature suggests standard enoxaparin dosing may not achieve target prophylactic anti-Xa levels. We hypothesize...

P-12 Postpartum vertebral compressive fractures in a young female with osteoporosis - A case report

Abstract Introduction Osteoporosis is а metabolic disorder characterized by low bone mass and deep changes in bone architecture that lead to an increased vertebral or hip fracture in elderly. Osteoporosis in young population is a very rare condition especially when is associated with compressive fractures. Pregnancy and postpartum-related osteoporosis is condition that occurs in the last trimester of pregnancy оr in the first months of lactation. It is self-limited condition that return to normal after 12-18 months. In rare cases leаds to spinal compressive fractures. Clinical Case We present a 33-year-old female with back pain that occurs after birth during the early lactation period. In consultation with an orthopedic surgeon, an X-ray was made on the thoracolumbar spinal column with a finding of vertebral compressive fractures. A DEXA scan (double energy-X rays of absorptiometry) is also made with the finding of vertebral osteoporosis and hip osteopenia. We calculate BMI and perform blood tests for vitamin D3, calcium, hormones and markers for bone metabolism. This was our patient's first birth, she was thin with height 157 cm, weight 42 kg and calculated BMI-17. Blood test showed very low concentration of vitamin D3- 16 ng/ml (20-44) with normal level of calcium- 1,20 mmol/l (1,10-1,40) and PTH-31,01 pg./ml (15-65). Thyroid, gonadal and adrenal axis was with normal function. We told the patient to stop the lactation and to take a supplementation of vitamin D3 2000 IE, Calcium 1000 mg and bisphosphonates (alendronate). After two years of treatment, we made a control DEXA scan. Our patient now has vertebral osteopenia, normal serum concentration of vitamin D (44 ng/ml) and her weight is 48 kg. She feels good, has no pain and no new fractures. Conclusion Pregnancy and lactation increase need for calcium and this condition is complemented by increased intestinal absorption of calcium and increased bone resorption of the mother's skeleton. Risk factors for low bone density are deficit of 1-25 OH vitamin D3, malnutrition, low body mass index, treatment with low dose of enoxaparin (LMWH), physical inactivity. Our patient has an increased risk of low bone density (she has a low body mass index, low serum concentration of 1–25 OH vitamin D3 and this was her first pregnancy). Normal serum level 1–25 OH vitamin D concentration is required to establish calcium metabolism and prevent low bone density, osteopenia or osteoporosis. Antiresorptive therapy with bisphosphonates lead to rapid improvement in bone density, prevent new fractures and relieves pain. Treatment of postpartum osteoporosis is debatable because this condition is reversible, so when we decide to treat or not to treat, we must consider present of fractures, pain and plan for future pregnancy.

Enoxaparin for VTE thromboprophylaxis during inpatient rehabilitation care: assessment of the standard fixed dosing regimen

BackgroundWe aimed to examine the efficiency of fixed daily dose enoxaparin (40 mg) thromboprophylaxis strategy for patients undergoing inpatient rehabilitation.MethodsThis was an observational, prospective, cohort study that included 63 hospitalized patients undergoing rehabilitative treatment following sub-acute ischemic stroke (SAIS) or spinal cord injury (SCI), with an indication for thromboprophylaxis. Anti-Xa level measured three hours post-drug administration (following three consecutive days of enoxaparin treatment or more) was utilised to assess in vivo enoxaparin activity. An anti-Xa level between 0.2-0.5 U/ml was considered evidence of effective antithrombotic activity.ResultsWe found sub-prophylactic levels of anti-Xa (<0.2 U/ml) in 19% (12/63). Results were within the recommended prophylactic range (0.2-0.5 U/ml) in 73% (46/63) and were supra-prophylactic (>0.5 U/ml) in 7.9% (5/63) of patients. Anti-Xa levels were found to inversely correlate with patients’ weight and renal function as defined by creatinine clearance (CrCl) (p<0.05).ConclusionsOur study confirmed that a one-size-fits-all approach for venous thromboembolism (VTE) prophylaxis may be inadequate for rehabilitation patient populations. The efficacy of fixed-dose enoxaparin prophylaxis is limited and may be influenced by renal function and weight. This study suggests that anti-Xa studies and prophylactic enoxaparin dose adjustments should be considered in certain patients, such as those who are underweight, overweight and or have suboptimal renal function.Trial registrationNo. NCT103593291, registered August 2018.

How enoxaparin underdosing and sex contribute to achieving therapeutic anti-Xa levels.

Anti-Xa serves as a clinical surrogate for assessing the efficacy and bleeding risk in patients treated with enoxaparin for thromboembolic events. Evidence from the literature and empirical observations suggest that patients are underdosed in clinical practice to avoid bleeding complications. This study aimed to investigate such underdosing of enoxaparin and its potential impact on achieving therapeutic anti-Xa levels. This multicentric, retrospective, observational study included patients with acute ischemic stroke due to atrial fibrillation. All patients received enoxaparin in the therapeutic setting with subsequent anti-Xa measurements. The one-sample, one-tailed Wilcoxon signed-rank test was used to identify a significant difference between the doses administered and the recommended daily dose. Logistic regression model analysis was performed to identify additional predictors affecting achievement of the therapeutic anti-Xa target range. Stepwise forward-backward selection with Akaike's information criterion as metric was applied to refine the logistic regression model. A total of 145 patients from the university hospitals of St. Pölten and Tulln in Lower Austria were included. The median daily enoxaparin dose administered was 1.23mg/kg, resulting in an overall target range achievement rate of 66%. As compared to recommended therapeutic doses, significant underdosing of enoxaparin was evident in both participating centers (p < 0.001). The calculated threshold dose to achieve the therapeutic target range with a 90% probability was 1.5mg/kg enoxaparin daily. Female sex was found to be a strong independent predictor of achieving a therapeutic target range (OR 9.44; 95% CI 3.40-30.05, p < 0.001). Despite the underdosing observed in both centers, therapeutic anti-Xa levels were achieved with lower than recommended doses of enoxaparin, and women required even lower doses than men. These findings warrant further confirmation by prospective studies.

Single-Dose enoxaparin for portomesenteric venous thrombosis prophylaxis after sleeve gastrectomy.

Portomesenteric venous thrombosis (PMVT) may complicate sleeve gastrectomy. We believe that single dose of enoxaparin postoperatively can reduce the risk of PMVT. The objective was to study the outcomes of enoxaparin single dose compared to other perioperative prophylactic doses in preventing PMVT. Participants included 590 patients who underwent laparoscopic sleeve gastrectomy (LSG). These retrospective cohort data were collected from patient medical charts after bariatric surgery. Patients were followed up in the close postoperative period and at 1, 3, 6, 12, and 18 months. Descriptive statistical analysis was carried out. The objective was to estimate the incidence of PMVT with postoperative single 40 mg subcutaneous enoxaparin prophylactic regimen. From January 2017 to December 2021, 590 patients with obesity underwent LSG. Five patients developed PMVT with an estimate incidence of 0.85%. Three patients had unexplained tachycardia and three patients had postoperative bleeding. Single-dose enoxaparin 40 mg is an effective thrombosis prophylaxis without increasing risk of bleeding.

Updated Meta-Analysis of Randomized Controlled Trials on Primary Outpatient Thromboprophylaxis (POTP) in Patients with Lung Cancer Receiving Chemotherapy

Introduction Lung cancer (LC) is the leading cause of cancer mortality in the USA. Thrombosis is the second leading cause of death in cancer patients and in recent years, several studies have been conducted to determine beneficial effect of POTP in reduction of VTE (venous thromboembolism) rate in solid cancer patients with the aim to improve the overall survival. We performed an updated meta- analysis of randomized control trials (RCTs) to determine the benefit and risk of POTP with low-molecular weight heparins (LMWHs) and direct oral anticoagulants (DOACs) in patients with LC receiving chemotherapy. Methods We performed a comprehensive literature search using MEDLINE and EMBASE databases through June 30, 2023. The references of all potential studies were also reviewed for any additional relevant studies. The RCTs with reduction in VTE as a primary or secondary endpoint and the major bleeding (MB) as a safety outcome were incorporated in the analysis. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR), and risk difference (RD) with 95% confidence interval (CI). Heterogeneity was assessed with Cochran's Q- statistic. Fixed effects model was applied. Results A total of 5,434 patients with LC from five RCTs and subgroups of another five RCTs were included in our meta-analysis. The prophylactic doses of bemiparin, certoparin, dalteparin, nadroparin, semuloparin and tinzaparin, intermediate dose of enoxaparin and prophylactic dose of rivaroxaban and apixaban were used in the studies. The duration of LMWH and DOAC ranged from 3 to 6 months. The randomization ratio was 2 to 1 in PROTECHT study and 1 to 1 in all other studies. The I 2 statistic for heterogeneity was 0, suggesting homogeneity among RCTs. The VTE incidence was 114 (4.12%) in PATP group and 207 (7.8%) in control group with a RR of 0.53 (95% CI: 0.43 to 0.67, P &amp;lt; 0.00001). The absolute RD in VTE was -0.04 (95% CI: -0.05 to -0.02, P &amp;lt; 0.00001) with an estimate of the number needed to treat (NNT) of 25 to prevent one VTE event. In subgroup analysis of PATP trials treated with LMWHs in study arm, VTE events were reported in 112 (4.2%) in PATP group and 202 (7.9%) in control group with a RR of 0.54 (95% CI: 0.43 to 0.67, P &amp;lt; 0.00001). The absolute RD in VTE was -0.04 (95% CI: -0.05 to -0.02, P &amp;lt; 0.00001). In subgroup analysis of PATP trials treated with DOACs in study arm, VTE events were reported in 2 (2.2%) in PATP group and 5 (5%) in control group with a RR of 0.46 (95% CI: 0.09 to 2.31, P=0.35). The absolute RD in VTE was -0.03 (95% CI: -0.08 to -0.03, P=0.36). Major bleeding (MB) events were reported in 34 (1.6%) patients in POTP group compared to 17 (0.86%) in control group according to an analysis of 7 RCTs. The pooled relative risk for MB was statistically significant at 1.84 (95% CI: 1.06 to 3.22, P = 0.03). Conclusions Our analysis showed that the relative risk reduction is 47% with a NNT of 25 to prevent one VTE with statistically significant increase in MB events in ambulatory patients with LC by providing POTP. In our subgroup meta-analysis of POTP with DOACs, there was no statistically significant difference in reduction of VTE in LC patients with Khorana Score ≥2. Hence, the selection of appropriate patients who are high risk for VTE is crucial and further studies are required to define high risk subsets of LC patients receiving chemotherapy who may benefit from POTP.

An Evaluation of the Appropriateness of Initial Enoxaparin Dosing Among Pediatric Patients.

Background Enoxaparin is a low molecular weight heparin that irreversibly inactivates factor Xa leading to the inhibition of clot formation. Despite the non-FDA approval in pediatrics, enoxaparin is recommended with an initial dose of 1.5mg/kg/q12hrs for patients aged ≤ 2 months and 1mg/kg/q12hrs for patients > 2 months, targeting therapeutic anti-Xa with a range of 0.5 to 1 units/mL. Due to more rapid clearance in pediatrics, our study aims to assess the need for initial higher doses than recommended by the guideline to reach the target anti-Xa level. Methods A retrospective chart review of all pediatric patients under all specialties who were treated with enoxaparin either in inpatient or outpatient settings between February 2021 and June 2022 at children's specialized hospital and meet the inclusion criteria, including age ≤ 15 years old and treated with enoxaparin with initial dose according to the American College of Chest Physicians (CHEST) guideline, while patients who received prophylaxis dosesdid not have anti-Xa levels or creatinine clearance < 30 mL/min/1.73m2 were excluded. Demographic data, laboratory data, and enoxaparin dosing were all collected to assess whether the initial enoxaparin dose will result in a therapeutic level as a primary endpoint and secondary endpoints including the average enoxaparin dose required to achieve the therapeutic level and to report any side effects. All data were entered and analyzed using the Statistical Package for the Social Sciences (IBM SPSS Statistics for Windows, IBM Corp., Version 25, Armonk, NY), and all categorical variables were reported as frequency and percentage while continuous variables expressed as mean ± SD and the study was approved by our research center institutional review board (IRB). Results Thirty patients were included in the study (17 males), 10 patients were aged ≤ 2 months, four were between 3 and 12 months and 16 were > 12 months, most of the patients received enoxaparin for deep vein thrombosis. In the majority of patients (76.7%), the initial dose failed to achieve the target anti-Xa while a mean dose of 2 mg/kg/q12hrs in patients ≤ 2 months, 1.7mg/kg/q12hrs in patients 3-12 months and 1.3 mg/kg/q12hrs in patients > 12 months was sufficient to reach the target level. After achieving a therapeutic anti-Xa level, only one patient experienced major bleeding while four patients experienced minor bleeding, no edema or thrombocytopenia were reported. Conclusion In conclusion, initiating enoxaparin according to the recommended dose by the guideline failed to achieve target anti-Xa in the majority of patients which necessitates starting enoxaparin with initial higher doses according to the patient's age to provide more prompt achievement of target anti-Xa.

Enoxaparin for Long-Term Therapy of Venous Thromboembolism in Patients with Cancer and Renal Insufficiency.

The optimal therapy of venous thromboembolism (VTE) in cancer patients with renal insufficiency (RI) is unknown. Current guidelines recommend to use low-molecular-weight heparin over direct oral anticoagulants to treat VTE in cancer patients at high risk of bleeding. We used the Registro Informatizado Enfermedad Tromboemb00F3lica (RIETE) registry to compare the 6-month incidence rates of (1) VTE recurrences versus major bleeding and (2) fatal pulmonary embolism (PE) versus fatal bleeding in three subgroups (those with mild, moderate, or severe RI) of cancer patients receiving enoxaparin monotherapy. From January 2009 through June 2022, 2,844 patients with RI received enoxaparin for ≥6 months: 1,432 (50%) had mild RI, 1,168 (41%) moderate RI, and 244 (8.6%) had severe RI. Overall, 68, 62, and 12%, respectively, received the recommended doses. Among patients with mild RI, the rates of VTE recurrences versus major bleeding (4.6 vs. 5.4%) and fatal PE versus fatal bleeding (1.3 vs. 1.2%) were similar. Among patients with moderate RI, VTE recurrences were half as common as major bleeding (3.1 vs. 6.3%), but fatal PE and fatal bleeding were close (1.8 vs. 1.2%). Among patients with severe RI, VTE recurrences were threefold less common than major bleeding (4.1 vs. 13%), but fatal PE was threefold more frequent than fatal bleeding (2.5 vs. 0.8%). During the first 10 days, fatal PE was fivefold more common than fatal bleeding (2.1 vs. 0.4%). Among cancer patients with severe RI, fatal PE was fivefold more common than fatal bleeding. The recommended doses of enoxaparin in these patients should be revisited.

Analysis of factors affecting enoxaparin effectiveness on coagulation, inflammation, and clinical outcomes in patients with COVID-19

Context: Hypercoagulopathy is a COVID-19 extra-pulmonary manifestation has drawn the attention of the scientists due to its risk of thromboembolism. Enoxaparin is an anticoagulant used to prevent hypercoagulopathy. Many factors have been associated with enoxaparin effectiveness. Aims: To analyze factors affecting enoxaparin effectiveness on coagulation, inflammation, and clinical outcomes. Methods: This retrospective cohort study involved hospitalized adult patients with COVID-19 from November 2020 to April 2021. Patients’ age, gender, body mass index (BMI), comorbidity, and laboratory results were extracted from medical records. Factors influencing enoxaparin efficacy on coagulation, inflammation, and clinical outcomes were analyzed using path analysis with SmartPLS 3.0 software. D-dimer and platelet values was determined as coagulation outcomes and C-reactive protein (CRP) value as an inflammation outcome. Clinical outcomes comprised of mortality, ventilator usage, and length of stay. Results: A total of 269 patients fulfilled the inclusion criteria. Most of the subjects were male (58%), 66% had comorbidities, 48.3% were aged ≥60 years old, and 65.8% had a BMI ≥ 25 kg/m2. Path analysis showed that age, BMI, and comorbidity affected disease severity (p&lt;0.05). Disease severity strongly influenced enoxaparin dosage (p=0.000). Dosage affected platelet value, ventilator usage, and mortality (p&lt;0.05). Gender did not influence disease severity, and dosage displayed no significant effect on length of stay, CRP, and D-dimer (p&gt;0.05). Conclusions: Dosage is the main factor influencing enoxaparin efficacy on coagulation, inflammation, and clinical outcomes. The dosage is strongly affected by disease severity, in which is predominantly influenced by age, BMI, and comorbidity.

Intermediate dose enoxaparin in hospitalized patients with moderate-severe COVID-19: a pilot phase II single-arm study, INHIXACOVID19

BackgroundRandomized clinical trials in non-critically ill COVID-19 patients showed that therapeutic-dose heparin increased survival with reduced organ support as compared with usual-care thromboprophylaxis, albeit with increased bleeding risk. The purpose of the study is to assess the safety of intermediate dose enoxaparin in hospitalized patients with moderate to severe COVID-19.MethodsA phase II single-arm interventional prospective study including patients receiving intermediate dose enoxaparin once daily according to body weight: 60 mg for 45–60 kg, 80 mg for 61–100 kg or 100 mg for > 100 kg for 14 days, with dose adjustment according to anti-factor Xa activity (target range: 0.4–0.6 UI/ml); an observational cohort (OC) included patients receiving enoxaparin 40 mg day for comparison. Follow-up was 90 days. Primary outcome was major bleeding within 30 and 90 days after treatment onset. Secondary outcome was the composite of all-cause 30 and 90-day mortality rates, disease severity at the end of treatment, intensive care unit (ICU) admission and length of ICU stay, length of hospitalization. All outcomes were adjudicated by an independent committee and analyzed before and after propensity score matching (PSm).ResultsMajor bleeding was similar in IC (1/98 1.02%) and in the OC (none), with only one event observed in a patient receiving concomitantly anti-platelet therapy. The composite outcome was observed in 53/98 patients (54%) in the IC and 132/203 (65%) patients in the OC (p = 0.07) before PSm, while it was observed in 50/90 patients (55.6%) in the IC and in 56/90 patients (62.2%) in the OC after PSm (p = 0.45). Length of hospitalization was lower in the IC than in OC [median 13 (IQR 8–16) vs 14 (11–21) days, p = 0.001], however it lost statistical significance after PSm (p = 0.08). At 30 days, two patients had venous thrombosis and two pulmonary embolism in the OC. Time to first negative RT-PCR were similar in the two groups.ConclusionsWeight adjusted intermediate dose heparin with anti-FXa monitoring is safe with potential positive impact on clinical course in COVID-19 non-critically ill patients.Trial registrationThe study INHIXACOVID19 was registred on ClinicalTrials.gov with the trial registration number (TRN) NCT04427098 on 11/06/2020.

Low Molecular Weight Heparin (Enoxaparin) Induced Hematuria in covid-19 Patients, Experience at a Covid Dedicated Hospital

Introduction: The nightmare of Covid -19 is still not over, due to its antigenic diversity. Covid produces a hypercoagulable state and results in thrombosis which is one of the leading causes of death of Covid 19 patients. Low molecular weight heparin (LMWH)- enoxaparin has proven the benefit of reducing morbidity and mortality by reducing the thrombotic effect. But unfortunately, this anticoagulant can result haematuria and unnecessary hemorrhagic manifestation that may require immediate intervention. The exact scenario of enoxaparin-induced hematuria in the covid patient is still not explored by standard high-volume study. Objective: Determine the incidence of hematuria by enoxaparin (LMWH) in covid-19 patients. Material and method: The study was conducted over 210 cases for 6 months duration. Indoor patients receiving subcutaneous enoxaparin who tested positive for Covid19-RTPCR or who had signs of Covid in chest CT (Computerized Tomography) were enrolled. Both microscopic and gross haematuria cases were included in the current study. Result: Out of 210 patients, only 5 patients (2.38%) developed haematuria. 2 had only microscopic and 3 had gross haematuria. Out of them, 3(60%) were male and 2(40%) were female. Hematuria was more common in those who received a higher dosage of enoxaparin. Conclusion: This study found that enoxaparin-induced haematuria in the covid patient is not uncommon, and hematuria is significantly higher in patients receiving higher doses. Further high-volume study is recommended on this issue. Bangladesh J. Urol. 2022; 25(2): 76-79

SAT324 Pulmonary Embolism Before And After Transsphenoidal Surgery In Cushing's Disease: Case Report.

Abstract Disclosure: A.B. Figueiredo: None. C.A. Baptista: None. C.R. Xavier: None. A.K. Nascimento: None. R.L. Dolci: None. A.L. dos Santos: None. J. Ethel: None. C.T. da Silva: None. N.M. Scalissi: None. J.V. Lima: None. Introduction: Patients with Cushing's syndrome (CS) have a 4-fold increased risk of thrombosis, due to increased synthesis of Von Willebrand factor and cortisol-stimulated fibrinogen, as well as increased synthesis of type 1 plasminogen activator inhibitor. The first 4 weeks after surgery are the period most susceptible to thromboembolism due to the worsening of the coagulation profile associated with the sudden reduction in the level of cortisol and its anti-inflammatory activity, leading to a thrombotic and inflammatory state. Case report: A 28-year-old woman, evaluated for bariatric surgery, was admitted to the emergency department complaining of dyspnea and palpitations that had started the day before. Supplementary oxygen therapy was instituted, the electrocardiogram showed a S1Q3T3 pattern, and chest angiotomography identified a thrombus in the arch of the right pulmonary artery and another in the left pulmonary artery. Thrombolysis was performed in the emergency room, followed by anticoagulation with intravenous heparin, resulting in clinical stability. He had typical symptoms of hypercortisolism such as obesity, early-onset hypertension, hirsutism, amenorrhea, and proximal weakness. During preparation for bariatric surgery, CS was suspected, with suppression test with dexamethasone and nocturnal salivary cortisol confirming hypercortisolism, and peripheral test with DDAVP and pituitary magnetic resonance imaging (MRI) confirming Cushing's disease by 8x4 mm adenoma. It was opted for clinical treatment with ketoconazole and anticoagulation for 6 months with transsphenoidal surgery. In the immediate postoperative period, it was planned to keep the patient off anticoagulants for the shortest possible time, with enoxaparin being restarted after surgery. On the 5th postoperative day, laboratory tests revealed cortisol of 1.7 mcg/dL and ACTH of 6.3 pg/mL, suggesting remission of the disease and supplementation with prednisone. On the 8th postoperative day, the patient complained of sudden dyspnea and desaturation, which led to the investigation of a new episode of pulmonary embolism. which was confirmed by chest angiotomography. Thus, a new Pulmonary Embolism was confirmed, this time with the use of full dose enoxaparin. The patient was referred to the ICU, where he received oxygen support and heparin infusion, with gradual clinical improvement and later, with anticoagulation for Warfarin with an INR goal of 2.5-3.0 and after 22 days of surgery, the patient achieved clinical stability and was discharged from the hospital. Conclusion: This case highlights the association of CS and thromboembolic events, especially Pulmonary Embolism. Presentation: Saturday, June 17, 2023

FRI196 Non-Hemorrhagic Adrenal Infarction in Pregnancy with Tuberous Sclerosis

Abstract Disclosure: A. Mahaldar: None. H. Al Jumaili: None. S.R. Campbell: None. M.Z. Baker: None. Background: Non hemorrhagic adrenal infarction is a rare diagnosis in pregnancy with less than 20 cases reported in literature so far. No cases have been reported in patients with tuberous sclerosis. Most patients present with abdominal pain. Clinical Case: 29 year old woman G2P1 presented at 35 weeks gestation with right upper quadrant pain. She reported two episodes of dizziness in first trimester but otherwise had an uneventful pregnancy prior to presentation. First pregnancy was uncomplicated. Past medical history included asymptomatic tuberous sclerosis. No previous history of blood clots. Physical examination revealed a distended abdomen appropriate for gestational age and right upper quadrant tenderness to palpation. Initial laboratory data was unremarkable except for leukocytosis with WBC 16.6 k/mm3 (4-11 k/mm3). Normal electrolytes and liver function tests. Abdominal ultrasound revealed cholelithiasis without evidence of acute cholecystitis and unremarkable renal findings. CT abdomen pelvis with contrast showed thickening with surrounding stranding of right adrenal gland suggesting acute adrenal infarction and multiple pancreatic cysts. 8 am cortisol was 4.9 mcg/dl (4.1-16.6 mcg/dl) and ACTH was 23 pg/ml (7.2-63.3 pg/ml). Patient had received 2 doses of betamethasone due to concern for preterm delivery at 48 hours and 36 hours prior to this blood draw. Hypercoagulable panel was sent prior to starting enoxaparin. Elevated Factor VIII &amp;gt;150% (50 to 150%) was noted as expected in pregnancy. Lupus anticoagulant was weakly positive with LA sensitive PTT 50.1 (0 to 51.9 sec). Anticardiolipin antibody and beta 2 glycoprotein antibody were normal. Patient was treated with hydrocortisone 15 mg by mouth daily and full dose enoxaparin for anticoagulation. At one month follow up 8 am cortisol was 24 mcg/dl. Hydrocortisone replacement was discontinued. Labor was uncomplicated with vaginal delivery at 38 weeks gestation. Day 1 postpartum at 7:30 AM cortisol was 20.94 mcg/dl. Patient was discharged home in a stable condition with continued anticoagulation with enoxaparin and no further hydrocortisone treatment. Conclusion: We present a case of non hemorrhagic adrenal infarction in a pregnant patient with tuberous sclerosis. Adrenal infarction without hemorrhage is rare. Anatomy of adrenal gland makes it prone to microvascular thrombosis and infarction in a thrombotic state because of single draining vein for venous drainage. Pregnancy as a hypercoagulable state has been previously associated with non hemorrhagic adrenal infarction in few case reports. Whether tuberous sclerosis played any role in our patient’s pathogenesis remains unclear as there are no data or case reports linking the two. In conclusion, the diagnosis of non hemorrhagic adrenal infarction needs to be considered in hypercoagulable or pregnant patients presenting with abdominal pain. Presentation: Friday, June 16, 2023

Extended Venous Thromboembolism Prophylaxis after Robotic Staging for Endometrial Cancer.

Our objectives were to estimate the incidence of venous thromboembolism (VTE) after robotic staging for endometrial cancer and to compare the incidence of VTE in patients who received a single dose of preoperative prophylaxis of enoxaparin with those who received extended postoperative prophylaxis. This study is a retrospective chart review of patients who underwent robot-assisted surgical staging for endometrial cancer. Patients were categorized into two groups: preoperative prophylaxis (PP), patients who received a single dose of enoxaparin preoperatively, and extended prophylaxis (EP), patients who received 28 days of enoxaparin postoperatively. In total, 148 patients were included, with 117 patients in the PP group and 31 patients in the EP group. The overall incidence of VTE within 30 days postoperatively was 0.67%. No significant difference was found between the PP and the EP groups (0.9% and 0%, respectively; P = 1.00). Most patients in the cohort had endometrioid adenocarcinoma (78%) with low-grade disease (70%), although there were a greater number of patients in the PP group with uterine serous carcinoma compared with the EP group (17% vs 10%; P = 0.034). The PP group had higher estimated blood loss (106 vs 81 mL; P = 0.009) and longer operative times (178 vs 151 min; P = 0.028) compared with the EP group. Significantly more patients in the PP group underwent lymph node dissection compared with the EP group (32% vs 7%; P = 0.008). The incidence of VTE following robot-assisted surgical staging for endometrial cancer in this study was 0.67%. No significant difference was found in VTE incidence between the PP group compared with the EP group. Mechanical prophylaxis plus a single dose of preoperative pharmacologic prophylaxis may suffice for low-risk patients following robotic surgical staging for endometrial cancer.