Anti-Xa Levels and Renal Function: Analysis of the First 32 Patients in the Tinzaparin in Renal Insufficiency for Venous Thromboembolism Study.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 906-906
Author(s):  
Wendy Lim ◽  
James Douketis ◽  
Luqi Wang ◽  
Karen Woods ◽  
Terri Schnurr ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Renal Function ◽  
Venous Thromboembolism ◽  
Renal Insufficiency ◽  
Therapeutic Dose ◽  
Dose Adjustment ◽  
Function Analysis ◽  
Bleeding Event ◽  
Renal Elimination ◽  
Minor Bleeding

Abstract Background: Low-molecular-weight heparin (LMWH) is renally eliminated; its use in patients with renal insufficiency may be associated with accumulation and an increased bleeding risk. Due to its higher molecular weight and greater negative charge, tinzaparin may be less dependent on renal elimination compared to other LMWHs. As a result, tinzaparin may be less prone to accumulate in patients with renal insufficiency. Purpose: To measure the anticoagulant effect of a 5-day course of therapeutic-dose tinzaparin used for the initial treatment of venous thromboembolism (VTE) in patients with varying degrees of renal insufficiency. We present the anti-Xa results of the first 32 patients enrolled in the study, correlated with renal function. Design: Prospective cohort study. Methods: In- and out-patients requiring therapeutic dose anticoagulation were enrolled and stratified into 4 groups based on creatinine clearance (CrCl): > 60 ml/min, 30–60 ml/min, ≤ 30 ml/min and hemodialysis-dependent. Tinzaparin 175 IU/kg was administered once daily for 5 days or until the INR was ≥ 2.0 with warfarin therapy. Trough anti-Xa levels were measured prior to the 3rd (day 3) and 5th (day 5) tinzaparin doses. Patients with an anti-Xa level > 0.5 IU/mL received tinzaparin dose adjustment using a standardized nomogram. Results: The relationship between anti-Xa levels and CrCl is shown in figure 1. One patient with a CrCl of 47 ml/min had a day 3 anti-Xa level of 0.62 IU/ml and required dose adjustment, resulting in a day 5 anti-Xa of 0.22 IU/ml. There has been one minor bleeding event (hematoma) following a traumatic intravenous catheter insertion. No major bleeding or recurrent VTE events have occurred. Conclusions: In a cohort of 32 patients with differing degrees of renal function including patients requiring hemodialysis, use of therapeutic-dose tinzaparin for 5 days does not appear to result in accumulation of the anticoagulant effects. There is no apparent correlation between anti-Xa level and renal function. Our results support ongoing evaluation of tinzaparin in patients with severe renal insufficiency. Figure 1. Anti-Xa levels an renal function Figure 1. Anti-Xa levels an renal function

Use of Therapeutic Dose Low Molecular Weight Heparin in Patients with Renal Insufficiency: Analysis of Anti-Xa Levels and Creatinine Clearance.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 884-884
Author(s):  
Wendy Lim ◽  
Manasa Sridhara ◽  
Luqi Wang ◽  
Krystyna Kinnon ◽  
James Douketis ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Renal Function ◽  
Renal Insufficiency ◽  
Creatinine Clearance ◽  
Therapeutic Dose ◽  
Low Molecular Weight Heparin ◽  
Dose Adjustment ◽  
Low Molecular Weight ◽  
Recurrent Vte ◽  
Dependent Patient

Abstract Low molecular weight heparin (LMWH) is predominantly eliminated by the kidneys. In patients with severe renal impairment, use of therapeutic dose LMWH may be associated with accumulation and a resultant bleeding risk. Tinzaparin may be less dependent on renal clearance due to its higher molecular mass and greater negative charge compared to other LMWHs. The objective of this prospective cohort study was to serially measure the anti-Xa anticoagulant effect of therapeutic dose tinzaparin over 5–7 days, used for the initial treatment of venous thromboembolism (VTE) in patients with varying degrees of renal insufficiency. We present the anti-Xa results from the first 78 patients enrolled in the study, correlated with renal function. In this study, consecutive in- and outpatients with objectively confirmed VTE requiring anticoagulation were enrolled and stratified into 4 groups based on the calculated Cockcroft-Gault creatinine clearance (CrCl): > 60 mL/min, 30–60 mL/min, ≤ 30 mL/min and hemodialysis-dependent. Tinzaparin 175 IU/kg was administered subcutaneously once daily for 5–7 days or until the INR ≥ 2.0 with warfarin therapy. Trough anti-Xa levels were measured prior to the 3rd, 5th and/or 7th tinzaparin doses. Patients with anti-Xa level > 0.5 IU/mL received tinzaparin dose adjustment using a standardized nomogram. Bleeding and recurrent VTE events were recorded. The relationship between anti-Xa levels and CrCl is shown in Figure 1. Based on our predefined anti-Xa threshold of 0.5 IU/mL, 5 of 78 patients (6.4%) required dose adjustment; 1 hemodialysis dependent patient, 2 patients with CrCl < 30 mL/min, 1 patient each with CrCl 30–60 and > 60 mL/min, respectively. None of these patients developed bleeding or recurrent VTE. Among all 78 patients, 1 hemodialysis-dependent patient developed a hematoma following a traumatic line insertion, and no patients developed recurrent VTE. In conclusion, in a cohort of 78 patients with differing degrees of renal function including patients requiring hemodialysis, use of therapeutic-dose tinzaparin for the initial treatment of VTE resulted in accumulation (defined by trough anti-Xa > 0.5 IU/mL) in 6% of patients. There appears to be a weak inverse relationship between renal function and trough anti-Xa levels, but does not result in clinically significant accumulation when tinzaparin is used for up to 7 days. Further evaluation of tinzaparin in patients with severe renal insufficiency is required. Figure Figure

Pharmacodynamics and Tolerance of Two Nadroparin Formulations (10,250 and 20,500 Anti Xa IU·ml-1) Delivered for 10 Days at Therapeutic Dose

1998 ◽  
Vol 79 (02) ◽  
pp. 338-341 ◽  
Author(s):  
C. Navarro ◽  
J. P. Cambus ◽  
H. Caplain ◽  
P. d’Azemar ◽  
J. Necciari ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Healthy Volunteers ◽  
Total Dose ◽  
Therapeutic Dose ◽  
Low Molecular Weight Heparin ◽  
Dose Effect ◽  
Low Molecular Weight ◽  
High Dose ◽  
Circadian Effect

SummaryVenous thromboembolism may be efficiently treated by once-a-day (o.d.) administration of a high dose of low molecular weight heparin (LMWH) instead of administration of the same total dose in two injections a day (b.i. d.). To reduce the volume of the subcutaneous (s.c.) injection, a more concentrated form of the drug is advisable. This study was designed to compare the bioavailability of 2 formulations of nadroparin containing 10,250 and 20,500 anti-Xa IU·ml-1 respectively. This was an open, randomized, cross-over study where 12 healthy volunteers (age 18-35) were enrolled. They received either 90 anti-Xa IU·kg-1 b.i. d. of the 10,250 IU preparation (treatment A), or 180 anti-Xa IU·kg-1 o.d. of the 20,500 IU preparation (treatment B) for 10 days. On day 1, the subjects were sampled between 0 and 12 h (treatment A) or between 0 and 24 h (treatment B). On day 10, they were sampled between 0 and 12 h and between 12 and 24 h (treatment A) or between 0 and 24 h (treatment B). Anti-Xa and anti-IIa activities were determined by specific chromogenic assays. The main result of the study was that the bioavailability of the anti-Xa activity of the 2 nadroparin formulations was equivalent, as shown by the comparison of the AUC0-12 h plus AUC12-24 h (treatment A) and the AUC0-24 h (treatment B), calculated on day 10. This study also allowed a number of interesting observations to be made. 1) Between day 1 and day 10, there was an accumulation of the anti-Xa activity for treatment A but not for treatment B (accumulation factors: 1.6 and 1.1 respectively); 2) On day 10, the AUC0-12 h were slightly but significantly lower than the AUC12-24 h suggesting a circadian effect for anti-Xa and anti-IIa activities; 3) the clearance of the anti-Xa activity was comparable at the 2-dose regimens, while that of the anti-IIa activity was lower in treatment B than in treatment A, indicating a significant dose effect for the pharmacodynamics of the longer heparin chains; 4) On average, the clearance of the anti-IIa activity was twice as high as that of the anti-Xa activity; 5) For treatment B, significant APTT prolongations were noticed at Tmax (prolongation factor: 1.7 ± 0.25), in relation with the anti-IIa activity (0.3 ± 0.1 IU·ml–1).

Venous Thromboembolism Prophylaxis with Low-Molecular-Weight Heparin in Primary Central Nervous System Lymphoma

2020 ◽  
pp. 1-6
Author(s):  
Stav Gazal ◽  
Eyal Lebel ◽  
Yosef Kalish ◽  
Chen Makranz ◽  
Moshe E. Gatt ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Central Nervous System ◽  
Nervous System ◽  
Venous Thromboembolism ◽  
Low Molecular Weight Heparin ◽  
Bleeding Event ◽  
Central Nervous System Lymphoma ◽  
B Cell Lymphoma ◽  
Low Molecular Weight ◽  
History Of

<b><i>Background:</i></b> Venous thromboembolism (VTE) is a frequent, potentially lethal complication in individuals with cancer. Patients with brain tumors are at particularly high risk for VTE. Primary central nervous system lymphoma (PCNSL) is a rare subtype of diffuse large B cell lymphoma, involving the craniospinal axis. The incidence of VTE in patients with PCNSL was reported as very high, occurring mostly in the early period of therapy. <b><i>Objectives:</i></b> We aimed to evaluate the efficacy and safety of prophylactic low-molecular-weight heparin (LMWH) throughout the treatment of PCNSL. <b><i>Patients:</i></b> All patients &#x3e;18 years of age diagnosed and treated for PCNSL at our institution in 2005–2017 were included. <b><i>Results:</i></b> There were 44 patients; mean age at diagnosis was 61.5 years. Three patients (6.8%) had a personal history of thrombosis, 11 (25%) had a history of diabetes or smoking, and 32 (72%) had an Eastern Cooperative Oncology Group performance status of 0–1 at diagnosis. During treatment with LMWH, no VTE events were recorded; 2 (4.5%) patients experienced a minor bleeding event and 1 (2.3%) a major bleeding event. <b><i>Conclusions:</i></b> Among our 44 patients with PCNSL treated with prophylactic LMWH, no VTE events were recorded, and only 1 (asymptomatic) intracranial bleed was recorded. Within the limitations of a retrospective nonrandomized study, our findings suggest that VTE prophylaxis may be beneficial for individuals with PCNSL.

scholarly journals Low Molecular Weight Heparin (LMWH) for Venous Thromboembolism (VTE) Prophylaxis in Patients with Primary Central Nervous System Lymphoma (PCNSL)

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2993-2993
Author(s):  
Deborah Rund ◽  
Stav Gazal ◽  
Yosef Kalish ◽  
Chen Makranz ◽  
Neta Goldschmidt
Keyword(s):  
Molecular Weight ◽  
Central Nervous System ◽  
Nervous System ◽  
Venous Thromboembolism ◽  
Low Molecular Weight Heparin ◽  
Medical Center ◽  
Bleeding Event ◽  
Central Nervous System Lymphoma ◽  
Low Molecular Weight ◽  
History Of

Abstract Introduction: Venous thromboembolism (VTE) is a frequent, potentially lethal, complication in patients with cancer. Patients with brain tumors are at a particularly high risk for VTE. Primary central nervous system lymphoma (PCNSL) is a rare subtype of diffuse large B-cell lymphoma, involving the cranio-spinal axis. The incidence of VTE in patients with PCNSL is as high as 30-60% in various series, occurring mostly in the early period of therapy. Due to this high incidence, the policy in our medical center since the year 2005, is to treat with prophylactic low molecular weight heparin (LMWH) from the time of PCNSL diagnosis until the end of treatment. We aimed to evaluate the incidence of VTE in patients with PCNSL treated with prophylactic LMWH. Material and methods: All patients ≥18 years who were diagnosed and treated for PCNSL in Hadassah-Hebrew University Medical Center between the years 2005-2017 were included in the study. We retrospectively reviewed their medical records for demographic details and initial disease characteristics (age at diagnosis, sex, performance status, laboratory results such as LDH, cerebrospinal fluid content and location of the growth), for details of risk factors for VTE such as diabetes, smoking or heart failure, and for personal or familial history of thrombosis. Therapeutic details including chemotherapy protocol, response to treatment and supportive care were compiled. Specifically we noted if prophylactic LMWH was given, if any complications developed due to the LMWH treatment and whether a VTE event occurred. Results: Forty four patients were included in the study. Mean age at diagnosis was 60.2 years and there were 27 (61%) females. Three (6.8%) patients had a personal history of thrombosis and 13 (29%) had a history of diabetes or smoking. Thirty two (72%) had an ECOG performance study of 0-1 at diagnosis and seven (16%) had leptomeningeal involvement. Forty one (93%) of patients were treated with a systemic high dose methotrexate (HDMTX) based protocol (mean of 7.6 courses of HDMTX per patient) and thirty two (73%) patients were treated with systemic rituximab. All 44 patients were treated with prophylactic LMWH, mostly at a dose of 40 mg per day (41 patients, 93%). Of the 44 patients, five (11%) discontinued treatment; 2 due to side effects (abnormal liver function tests and subdural hematoma (SDH)) and 3 for an unknown reason. Three (7%) patients had a minor bleeding event (gum, conjunctival, Ommaya reservoir catheter tract). One patient (2.3%) had a major bleeding event (SDH) while on LMWH treatment which was found on routine MRI imaging of the brain as he was asymptomatic. No VTE events (0%) were recorded in patients treated with LMWH. Two patients had a VTE, however both patients were off LMWH treatment at the time of VTE (one stopped LMWH, the other was diagnosed with VTE concurrently with the diagnosis of PCNSL). Conclusions: In our group of 44 PCNSL patients, prophylactic use of LMWH was highly effective, with no VTE events. Two cases of VTE occurred in our patient group, both occurred while the patients were off LMWH treatment. Only one, asymptomatic, intracranial bleed was recorded, indicating the relative safety of this treatment in PCNSL patients. Further prospective studies should be done to support the routine use of this prophylactic strategy. Disclosures No relevant conflicts of interest to declare.

Confirmation of the Safety and Efficacy of the Kovacs 10 mg Warfarin Initiation Nomogram for Venous Thromboembolism and Derivation of a Rule To Predict the Weekly Maintenance Dose.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1864-1864
Author(s):  
Katherine J. Monkman ◽  
Alejandro Lazo-Langner ◽  
Michael J. Kovacs
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Maintenance Dose ◽  
Bleeding Event ◽  
Warfarin Dose ◽  
Patient Specific ◽  
Minor Bleeding ◽  
Care Hospital ◽  
Safety And Efficacy ◽  
Days Of Therapy

Abstract Background: Initiation of oral anticoagulant therapy for acute venous thromboembolism requires balancing the need for rapid anticoagulation with the risk of major bleeding. The optimal means of initiating warfarin therapy in the outpatient setting remains controversial. We have previously demonstrated the efficacy of a 10 mg initiation nomogram in comparison to a 5 mg nomogram in a published RCT (Kovacs et al. 2003). Although this nomogram is used in many centres, some are still reluctant to use it due to a fear of potential increased bleeding. Objective: To validate the safety and efficacy of the Kovacs 10 mg warfarin initiation nomogram and to identify patient-specific factors predictive of a maintenance warfarin dose. Methods: We performed a retrospective chart review of 430 consecutive patients who were treated prospectively according to the Kovacs nomogram in the outpatient thromboembolism clinic of a tertiary care hospital. Data were analyzed for 90 days following the initiation of anticoagulation. All patients were treated with standard subcutaneous LMWH for 5 to 7 days and warfarin for a minimum of 3 months. Major bleeding and recurrent venous thromboembolism were defined according to standard criteria. Results: 408 of 430 patients were followed for at least 90 days. Six patients (1.5%) experienced recurrent thrombosis, 3 (1%) suffered a major bleeding event, and 3 (1%) suffered a minor bleeding event requiring treatment with vitamin K. There were no deaths related to thrombosis or bleeding. Three patients died from unrelated causes. Ninety percent of the 297 patients who adhered to the nomogram achieved a therapeutic INR by day 5. Only 8 (2.7%) of patients who adhered to the nomogram had an INR measurement of ≥ 5.0 in the first 8 days of therapy. None of these suffered a major or minor bleed. The most common reason for non-adherence to the nomogram was failure to get an INR test on the days specified, due to the unavailability of testing on weekends and holidays or to patient non-compliance. On univariate analysis, six factors were found to be significantly associated (p &lt; 0.05) with the weekly maintenance warfarin dose: Day 3 INR, weight, age, creatinine, gender, and presence of malignancy. The day 3 INR was inversely related to the maintenance dose and was the most predictive factor (R2 = 0.397). Multivariate regression was performed using the above six variables. Gender and presence of malignancy were removed from the model because they did not meet the criteria for significance (p &lt; 0.10). Regression using the remaining variables generated the following model: Weekly maintenance dose = 63.835/(Day 3 INR) − 0.265(Age) + 0.115(Weight) − 0.061(Creatinine) + 8.126. R2 = 0.515. Conclusions: The Kovacs 10 mg nomogram results in the rapid achievement of a therapeutic INR without a high incidence of bleeding events. The day 3 INR is strongly predictive of the required maintenance dose. If prospectively validated, our maintenance dose model would provide a simple means of estimating the appropriate maintenance dose using readily available information and without a need for genetic testing.

Prospective, Open-label clinical Trial of Bivalirudin in Children with Venous Thromboembolism

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1165-1165
Author(s):  
Sarah H. O'Brien ◽  
Donald Yee ◽  
Jessica Lira ◽  
Neil A Goldenberg ◽  
Guy Young
Keyword(s):  
Venous Thromboembolism ◽  
Complete Resolution ◽  
High Performance ◽  
Recurrent Events ◽  
Bleeding Event ◽  
Thrombin Inhibitor ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Open Label ◽  
Partial Resolution

Abstract Abstract 1165 Background: Bivalirudin (BIV) is a direct thrombin inhibitor with a favorable pharmacologic profile in comparison to heparin. In a previous study in children <6 months of age with venous thromboembolism (VTE), bivalirudin was demonstrated to be a safe and potentially more effective anticoagulant. The present study's aims were to assess the safety, dosing, pharmacokinetics, pharmacodynamics, and efficacy of BIV in children >6 months of age. Methods: This prospective, open-label study evaluated the use of BIV for initial treatment of a new VTE in children between 6 months and 18 years of age. Eligible subjects received a BIV bolus of 0.125mg/kg followed by an initial continuous infusion of 0.125mg/kg/hour which was adjusted as needed to achieve a PTT of 1.5–2.5x their baseline PTT. BIV levels by high performance liquid chromatography and PTTs were tested simultaneously 5 times in the first 24 hours, daily thereafter and following all dose adjustments. Subjects remained on BIV until they were transitioned to long-term anticoagulant treatments. Imaging was required to confirm the presence of a VTE and follow-up imaging was obtained at 2–3 days and 30 days following initiation of anticoagulation. Subjects were closely monitored for bleeding and adverse events. Results: 18 subjects (11M:7F) ranging in age from 9 months-17 years completed the study. There were no major bleeding events and one minor bleeding event. Outcome of VTE: at 2–3 days, 2 subjects had complete resolution and 7 subjects had partial resolution while at 30 days, 7 subjects had complete resolution and 9 subjects had partial resolution. There were no symptomatic recurrent events or any asymptomatic local progressions by surveillance imaging. Seven subjects required no dose adjustments during their course of treatment ranging between 2–5 days. See figure for correlation of PTT with BIV levels [each circle represents one subject with their mean PTT and BIV level with the standard deviations (r2=0.64)]. Conclusions: BIV offers a potentially safer, more effective and pharmacologically more predictable alternative to heparin for initial anticoagulation of children with VTE. Pharmacokinetic-pharmacodynamic correlation was excellent suggesting PTT as an acceptable monitoring strategy for BIV in this population. Further studies comparing BIV to heparin should be conducted. Disclosures: Off Label Use: Bivalirudin is not approved for use in children. Goldenberg:Eisai Inc: Research Funding; Pfizer Inc: Membership on an entity's Board of Directors or advisory committees; CPC Clinical Research: Consultancy.

Impact Of Renal Insufficiency and Obesity On Safety and Outcomes Of BEAM Conditioning

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3281-3281
Author(s):  
Salma Afifi ◽  
Nelly G. Adel ◽  
Zhigang Zhang ◽  
Weiji Shi ◽  
Craig H. Moskowitz ◽  
...  
Keyword(s):  
Overall Survival ◽  
Renal Function ◽  
Multivariate Analysis ◽  
Febrile Neutropenia ◽  
Renal Insufficiency ◽  
Dose Adjustment ◽  
Organ Damage ◽  
Cell Transplant ◽  
Relapse Risk ◽  
Prior Therapy

Abstract Introduction BEAM (carmustine, etoposide, cytarabine and melphalan) is a standard conditioning regimen for patients with NHL undergoing autotransplant. Guidelines do not address whether patients with marginal renal function or obesity should undergo dose-adjustment to limit toxicity, and practices vary among centers. Methods We reviewed all patients who had BEAM autotransplant at MSKCC, 9/2003 - 12/2011; none received dose adjustment for chronic renal insufficiency [CRI, creatinine clearance (CrCl) 29-59 ml/min] or obesity (BMI>30). Outcomes included OS, relapse risk, transplant length of stay (LOS), and incidence of toxicities including mucositis, febrile neutropenia, and organ damage (acute renal failure by AKIN criteria; pulmonary toxicity requiring oxygen or corticosteroids; heart failure requiring inotropic support). Uni- and multivariate analysis evaluated association with baseline renal function and BMI, as well as age, histology, prior therapy, disease response, and comorbidity (hematopoietic stem cell transplant comorbidity index ≥4). Logistic regression was used for toxicity endpoints; linear regression and ANOVA were used for LOS; and Cox regression model and Gray’s competing risks were used for OS and relapse risk. Results 343 patients received BEAM during the study period; median (range) age=56 (17-73), estimated CrCl=92 (29-208), and BMI=27.6 (16-47). 12% had CRI and 33% were obese (12% BMI≥35, 3% BMI≥40). Stepwise multivariate analysis showed CRI (OR 2.9, P<0.01) and obesity (OR 2.5, P<0.01) were associated with risk of organ damage independent of comorbidity and histology. Mucositis and febrile neutropenia were not associated with CRI or obesity. CRI (P=0.03), but not obesity, was associated with longer LOS. Relapse risk was associated with histology (PTCL vs. DLBCL, HR 2.3, P=0.01) and response at transplant (PR vs. CR, HR 2.3, P<0.01), but not CRI or obesity. Obesity was not clearly associated with overall survival (HR 0.62, P=0.10, NS), but CRI was associated with worse overall survival (HR 2.2, P<0.01) independent of disease status (for PR, HR=2.0, P=0.01), histology, prior therapy, or comorbidity (P=NS). However, 100d mortality was uncommon in patients with preserved (6/303, 2%) or impaired (2/40, 5%) renal function (P=NS). Conclusions Patients with CRI or obesity experience increased risks of acute organ damage, and those with CRI have inferior OS, but 100d mortality remains low in both groups. Our findings do not support routine dose-modification of BEAM for obesity or moderate renal insufficiency. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Safety and Efficacy of Enoxaparin Compared With Unfractionated Heparin for Venous Thromboembolism Prophylaxis in Hemodialysis Patients

2017 ◽  
Vol 52 (9) ◽  
pp. 623-627 ◽  
Author(s):  
Melissa S. Green ◽  
Katie B. Tellor ◽  
Amanda R. Buckallew
Keyword(s):  
Venous Thromboembolism ◽  
Unfractionated Heparin ◽  
Bleeding Complications ◽  
Secondary Outcome ◽  
Renal Elimination ◽  
Minor Bleeding ◽  
Safety And Efficacy ◽  
Vte Prophylaxis ◽  
Medically Ill ◽  
Medically Ill Patients

Background: Enoxaparin, a low-molecular-weight heparin approved for prophylaxis in patients at risk for venous thromboembolism (VTE), offers several advantages compared with unfractionated heparin (UFH). Enoxaparin is primarily excreted through renal elimination and is currently not recommended in patients receiving hemodialysis (HD) due to potential increased bleeding complications. To date, there are limited safety and efficacy data supporting the use of enoxaparin in this patient population for VTE prophylaxis. Objective: The aim of this study was to compare the safety and efficacy of enoxaparin with UFH for deep venous thromboembolism (DVT) prophylaxis in medically ill HD patients. Methods and Results: This retrospective cohort study examined medically ill patients who received HD and were concomitantly prescribed enoxaparin or UFH for at least 2 consecutive days for VTE prophylaxis. A total of 225 patients (150 received UFH and 75 received enoxaparin) were evaluated in chronological order. The primary outcome was a composite of major, clinically relevant nonmajor, and minor bleeding based on International Society on Thrombosis and Haemostasis bleeding definitions. The secondary outcome was the occurrence of a confirmed thrombotic event. Baseline characteristics were similar between the cohorts. One patient in each cohort had a documented bleed (UFH = 0.7%, enoxaparin = 1.3%, P > .05) during the admission assessed; however, neither bleed was related to the prophylactic agent utilized. No patients developed a VTE during the index hospitalization. Conclusions: This study demonstrates that enoxaparin may be as safe and effective as UFH for VTE prophylaxis in medically ill patients receiving HD.

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