Community-Onset Venous Thromboembolism in Children: Pediatric Emergency Medicine Perspectives

2021 ◽  
Author(s):  
Marisol Betensky ◽  
Melissa White ◽  
Simone L. Lawson ◽  
Neil A. Goldenberg
Keyword(s):  
Emergency Medicine ◽  
Venous Thromboembolism ◽  
Imaging Modality ◽  
Anticoagulation Therapy ◽  
Pediatric Emergency ◽  
Increased Risk ◽  
Compression Ultrasound ◽  
Clinically Significant ◽  
Poor Outcomes ◽  
High Index Of Suspicion

AbstractPediatric venous thromboembolism (VTE) is a condition increasingly encountered by emergency medicine physicians. Unfortunately, despite increased incidence, the diagnosis of pediatric VTE relies on a high index of suspicion from clinicians. Delays in diagnosis and initiation of treatment can lead to poor outcomes in children, including an increased risk of mortality from pulmonary embolism, increased risk of VTE recurrence, and the development of the post-thrombotic syndrome. The majority of pediatric VTE events are associated with the presence of at least one underlying prothrombotic risk. Timely recognition of these risk factors in the emergency department (ED) setting is paramount for a prompt diagnosis and treatment initiation. Compared with children with hospital-acquired VTE, children presenting to the ED with new onset VTE tend to be older (>11 years of age), have a lower incidence of co-morbidities, and present more frequently with a deep venous thrombosis of the lower extremity. Currently, there are no validated pediatric-specific VTE clinical pretest probability tools that reliably assist with the accurate and timely diagnosis of pediatric VTE. Compression ultrasound with Doppler is the most common imaging modality used for VTE diagnosis, and low molecular weight heparins are the most common anticoagulants initiated in children presenting with VTE in the ED. Special consideration should be given to patients who present to the ED already on anticoagulation therapy who may require acute management for clinically-significant bleeding or change in antithrombotic therapy approach for progression/recurrence of VTE.

scholarly journals Advances in the Diagnosis of Venous Thromboembolism: A Literature Review

Diagnostics ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. 365 ◽  
Author(s):  
Harish Patel ◽  
Haozhe Sun ◽  
Ali N. Hussain ◽  
Trupti Vakde
Keyword(s):  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Valsalva Maneuver ◽  
Imaging Modality ◽  
Diagnostic Algorithm ◽  
Pulmonary Angiography ◽  
Vein Thrombosis ◽  
Compression Ultrasound ◽  
Test Probability ◽  
D Dimer

The incidence of venous thromboembolism (VTE), including lower extremity deep vein thrombosis (DVT) and pulmonary embolism (PE) is increasing. The increase in suspicion for VTE has lowered the threshold for performing imaging studies to confirm diagnosis of VTE. However, only 20% of suspected cases have a confirmed diagnosis of VTE. Development of pulmonary embolism rule-out criteria (PERC) and update in pre-test probability have changed the paradigm of ruling-out patient with low index of suspicion. The D-dimer test in conjunction to the pre-test probability has been utilized in VTE diagnosis. The age appropriate D-dimer cutoff and inclusion of YEARS algorithm (signs of the DVT, hemoptysis and whether PE is the likely diagnosis) for the D-dimer cutoff have been recent updates in the evaluation of suspected PE. Multi-detector computed tomography pulmonary angiography (CTPA) and compression ultrasound (CUS) are the preferred imaging modality to diagnose PE and DVT respectively. The VTE diagnostic algorithm do differ in pregnant individuals. The prerequisite of avoiding excessive radiation has recruited planar ventilation-perfusion (V/Q) scan as preferred in pregnant patients to evaluate for PE. The modification of CUS protocol with addition of the Valsalva maneuver should be performed while evaluating DVT in pregnant individual.

scholarly journals Canadian consensus recommendations on the management of venous thromboembolism in patients with cancer. Part 2: treatment

2015 ◽  
Vol 22 (2) ◽  
pp. 144 ◽  
Author(s):  
J.C. Easaw ◽  
M.A. Shea-Budgell ◽  
C.M.J. Wu ◽  
P.M. Czaykowski ◽  
J. Kassis ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Renal Insufficiency ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Factor Xa ◽  
Patients With Cancer ◽  
Clinical Scenarios ◽  
Increased Risk

Patients with cancer are at increased risk of venous thromboembolism (vte). Anticoagulation therapy is used to treat vte; however, patients with cancer have unique clinical circumstances that can often make decisions surrounding the administration of therapeutic anticoagulation complicated. No national Canadian guidelines on the management of established cancer-associated thrombosis have been published. We therefore aimed to develop a consensus-based, evidence-informed guideline on the topic.PubMed was searched for clinical trials and meta-analyses published between 2002 and 2013. Reference lists of key articles were hand-searched for additional publications. Content experts from across Canada were assembled to review the evidence and make recommendations.Low molecular weight heparin is the treatment of choice for cancer patients with established vte. Direct oral anticoagulants are not recommended for the treatment of vte at this time. Specific clinical scenarios, including the presence of an indwelling venous catheter, renal insufficiency, and thrombocytopenia, warrant modifications in the therapeutic administration of anticoagulation therapy. Patients with recurrent vte should receive extended (>3 months) anticoagulant therapy. Incidental vte should generally be treated in the same manner as symptomatic vte. There is no evidence to support the monitoring of anti–factor Xa levels in clinically stable cancer patients receiving prophylactic anticoagulation; however, levels of anti–factor Xa could be checked at baseline and periodically thereafter in patients with renal insufficiency. Follow-up and education about the signs and symptoms of vte are important components of ongoing patient care.

scholarly journals Evaluation of Direct Oral Anticoagulants for the Treatment of Venous Thromboembolism in the Oncology Population

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5026-5026
Author(s):  
Jessica Hedvat ◽  
Christina Howlett ◽  
James K. McCloskey ◽  
Ruchi Jain
Keyword(s):  
Venous Thromboembolism ◽  
High Risk ◽  
Cancer Patients ◽  
Bleeding Episode ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Package Insert ◽  
Increased Risk ◽  
Clinically Significant ◽  
Risk For Bleeding

Abstract INTRODUCTION: Anticoagulant management of cancer-associated thrombosis is challenging since this patient population is concurrently at an increased risk for bleeding. The use of direct oral anticoagulants [(DOACs) dabigatran, rivaroxaban, apixaban] is not recommended for the treatment of venous thromboembolism (VTE) in cancer patients since there is limited data in this patient population. Despite limited evidence for use, DOACs are commonly prescribed due to ease of administration and lack of required laboratory monitoring. The objective of this study was to evaluate the practice and safety patterns of the DOACs when used for VTE treatment in the oncology population at Hackensack University Medical Center (HackensackUMC). METHODS: This study was a retrospective chart review of adult cancer patients treated at HackensackUMC who received dabigatran, rivaroxaban, or apixaban for the treatment of VTE. The protocol was reviewed and approved by the Institutional Review Board. Patients were identified through a computer generated report of the DOACs which included patients on all inpatient adult oncology floors at HackensackUMC from January 2013 to October 2015. Patients were included in this study if they were 18 years of age or older, admitted to an oncology floor, receiving a DOAC for VTE treatment for at least 48 hours, and had active cancer. Patients were excluded from this study if they were receiving hemodialysis or receiving a DOAC exclusively for the indication of atrial fibrillation. The primary outcomes of this study included the percentage of patients who were receiving a DOAC dosage consistent with that of the package insert and the percentage of patients who experienced clinically significant bleeding. The secondary outcomes of this study included the percentage of patients who had their DOAC held for thrombocytopenia and high risk procedures. Descriptive statistics were used to analyze study outcomes. RESULTS: Of the 126 patients screened, 39 patients were included. Thirty-five patients were on rivaroxaban and 4 patients were on apixaban (Table 1). Ten of 39 patients (26%) were not receiving a DOAC dosage consistent with that of the package insert. Of these 10 patients identified, the majority were receiving a lower DOAC dose than is recommended in the package insert. Our assumption is that these patients received a lower than recommended dose due to concerns for increased risk of bleeding. No patients experienced clinically significant bleeding. Four of 39 patients (10%) experienced a minor bleeding episode, all of which were gastrointestinal and/or genitourinary bleeds (Table 2). Four of 14 thrombocytopenic patients (29%) did not have their DOAC dose held for thrombocytopenia (none of which experienced a bleeding episode). All patients had their DOACs appropriately held for all procedures. CONCLUSION: Increased education and awareness on manufacturer recommended dosing of DOACs is warranted for oncology prescribers. Despite the increased risk for bleeding in cancer patients, no clinically significant bleeding events were identified in our patient cohort. To our knowledge, this is the first study to evaluate the use of DOACs for VTE treatment in patients with cancer at a high risk for bleeding. This data suggests that the use of DOACs may be safe to use for VTE treatment in the oncology population. This study may provide foundation for larger, randomized, controlled trials to determine whether DOACs should be used for VTE treatment in cancer patients. Disclosures Howlett: Eisai: Honoraria; Amgen: Honoraria; Pfizer: Honoraria; Sandoz: Honoraria; Teva: Speakers Bureau. McCloskey:Ariad: Consultancy, Speakers Bureau; Amgen: Speakers Bureau; Novartis: Speakers Bureau.

scholarly journals Risk of recurrent venous thromboembolism in COPD patients: results from a prospective cohort study

2017 ◽  
Vol 50 (1) ◽  
pp. 1700094 ◽  
Author(s):  
Raphael Le Mao ◽  
Cécile Tromeur ◽  
Amélie Bazire ◽  
Maelenn Gouillou ◽  
Marie Guegan ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Prospective Cohort ◽  
Multivariate Analyses ◽  
Anticoagulation Therapy ◽  
Secondary Outcome ◽  
Risk Of Death ◽  
Copd Patients ◽  
Increased Risk ◽  
Recurrent Venous Thromboembolism ◽  
Recurrent Vte

We aimed to assess the risk of recurrent venous thromboembolism (VTE) in patients with chronic obstructive pulmonary disease (COPD) following cessation of anticoagulation therapy.In a prospective cohort of 1468 patients with a documented episode of VTE, followed for up to 5 years after cessation of anticoagulation therapy, the diagnosis of COPD was confirmed in 136. The main outcome was recurrent VTE. The secondary outcome was overall mortality. Univariate and multivariate analyses were performed to identify the risk factors of recurrence.Of the 1468 patients included, recurrent VTE was observed in 306 (34 with COPD and 272 without) during a median follow-up period of 36.5 months. The incidence rate of recurrent VTE was 9.1% (95% CI 6.5–12.8) for COPD patients and 7.0% (95% CI 6.2–7.9) for non-COPD patients. COPD was not associated with an increased risk of VTE recurrence on univariate or multivariate analyses (hazard ratio: 1.0 (95% CI 0.7–1.4)). The risk of death, adjusted for demographic and clinical characteristics, showed no increase in COPD patients, as compared to non-COPD patients.In patients with COPD who had an acute episode of VTE, the risk of recurrent VTE was not any higher than that in non-COPD patients.

scholarly journals Broadening the Categories of Patients Eligible for Extended Venous Thromboembolism Treatment

2019 ◽  
Vol 120 (01) ◽  
pp. 014-026 ◽  
Author(s):  
Marc Schindewolf ◽  
Jeffrey Ian Weitz
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Venous Thromboembolism ◽  
Profile Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Specific Risk ◽  
Increased Risk

AbstractTraditionally, venous thromboembolism (VTE) resulting from major transient risk factors (e.g., surgery or trauma) or a major persistent risk factor such as cancer, has been defined as being provoked, whereas unprovoked VTE encompasses events without an identifiable cause. These categorizations influence anticoagulant treatment duration; unlike VTE provoked by major transient risk factors, extended anticoagulation beyond 3 months is advised for patients with cancer or unprovoked VTE due to risk persistence after treatment cessation. However, some patients with VTE provoked by minor transient or minor persistent risk factors may also be candidates for extended anticoagulation therapy due to the continuing risk of recurrence. In patients who require extended therapy, vitamin K antagonists (VKAs) are effective but are associated with an increased risk of bleeding and various treatment burdens (e.g., anticoagulation monitoring and dose adjustment). Evaluations of extended VTE treatment with the less-burdensome direct oral anticoagulants such as apixaban, dabigatran, edoxaban, and rivaroxaban show that they are at least as safe and effective as VKAs in a broad range of patients. In addition, apixaban and rivaroxaban offer more than one dosing option, allowing tailoring of treatment to the patient's specific risk factor profile. Analysis of more granular definitions for risk factor groupings has also yielded vital information on the most appropriate strategies for the treatment of patients with specific risk factors, highlighting that extended anticoagulation treatment may benefit those with minor transient and persistent environmental and nonenvironmental risk factors who commonly receive shorter-duration therapy.

Risk Factors for Major Bleeding during Prolonged Anticoagulation Therapy in Patients with Venous Thromboembolism: From the COMMAND VTE Registry

2019 ◽  
Vol 119 (09) ◽  
pp. 1498-1507 ◽  
Author(s):  
Kitae Kim ◽  
Yugo Yamashita ◽  
Takeshi Morimoto ◽  
Takeshi Kitai ◽  
Takafumi Yamane ◽  
...  
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Acute Phase ◽  
Major Bleeding ◽  
Anticoagulation Therapy ◽  
Bleeding Events ◽  
Increased Risk ◽  
Major Bleeding Events ◽  
Active Cancer

Background There are limited data assessing the risk for bleeding on anticoagulation therapy beyond the acute phase in patients with venous thromboembolism (VTE). The present study aimed to identify risk factors for major bleeding during prolonged anticoagulation therapy in VTE patients. Patients and Methods The COMMAND VTE Registry is a multicenter registry enrolling 3,027 consecutive patients with acute symptomatic VTE. The current study population consisted of 2,728 patients who received anticoagulation therapy beyond the acute phase, after excluding those patients with major bleeding events (n = 48), death (n = 66), or loss to follow-up (n = 32) during the initial parenteral anticoagulation period within 10 days after diagnosis, and those without anticoagulation therapy beyond 10 days after diagnosis (n = 153). Results During the median follow-up period of 555 days, major bleeding occurred in 189 patients (70 patients within 3 months; 119 patients beyond 3 months) with fatal bleeding in 24 patients (13%). The cumulative incidence of major bleeding was 2.7% at 3 months, 5.2% at 1 year, and 11.8% at 5 years. Active cancer (hazard ratio [HR], 3.06, 95% confidence interval [CI], 2.23–4.18), previous major bleeding (HR, 2.38, 95% CI, 1.51–3.59), anemia (HR, 1.75, 95% CI, 1.27–2.43), thrombocytopenia (HR, 2.11, 95% CI, 1.27–3.33), and age ≥75 years (HR, 1.64, 95% CI, 1.22–2.20) were independently associated with an increased risk for major bleeding by the multivariable Cox regression model. Conclusion Major bleeding events were not uncommon during prolonged anticoagulation therapy in real-world VTE patients. Active cancer, previous major bleeding, anemia, thrombocytopenia, and old age were the independent risk factors for major bleeding.

Risk of bleeding and significant thrombocytopenia in cancer patients treated with immune checkpoint inhibitors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15000-e15000
Author(s):  
Tariq Zuheir Kewan ◽  
Ramsha Ahmed ◽  
Sura Alqaisi ◽  
Fahrettin Covut ◽  
Monica Flores ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Checkpoint Inhibitors ◽  
Anticoagulation Therapy ◽  
Cleveland Clinic ◽  
Immune Checkpoints ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Clinically Significant

e15000 Background: Immune checkpoints inhibitors (ICIs) are associated with multiple side effects. Complications can affect any organ system including; endocrine, gastrointestinal, pulmonary, and less frequently hematological system.We evaluated the risk of bleeding and significant thrombocytopenia in cancer patients (pts) treated with ICIs. Methods: Cancer pts treated with ICIs between 01/2015 and 7/2019 at Cleveland Clinic Foundation were retrospectively reviewed. Platelets (plts) count and hemoglobin (hb) level at baseline, after one month and 3 months of treatment were reviewed. Thrombocytopenia was defined as plts count < 150,000. In pts with thrombocytopenia at baseline, more than 50% drop in the plts count was considered significant. Pts were followed-up for one year after ICIs treatment initiation for significant bleeding. Results: We identified 555 cancer pts treated with ICIs. Of these pts 65% were males. Among all included pts, 53% had lung cancer, 23% had genitourinary cancers, 17% had melanoma, 3% had gastrointestinal cancers, and 5% had other cancer types. Nivolumab, pembrolizumab, ipilimumab, and atezolizumab were used in 62%, 27%, 14%, and 12% respectively. Clinically significant bleeding, thrombocytopenia after one month and 3 months of treatment were identified in 21%, 6%, and 7% respectively. Of all pts who developed bleeding, 8% had gastrointestinal bleeding, 5% had intracerebral hemorrhage, and 3 % had hemoptysis. Only 23% of the pts who developed bleeding were receiving anticoagulation therapy. In multivariate analysis, breast cancer as primary malignancy (p = .03) and atezolizumab (p = 0.02) were predictors of clinically significant bleeding. Also, nivolumab was associated with increased risk of significant thrombocytopenia after one month of treatment (p = .02). There was no significant association between the use of specific medication and the development of significant anemia. Median overall survival time was not statistically different in patients who had bleeding compared to no bleeding group, 12.6 months (95% CI:10.8-14.5) and 12.4 months (95% CI:10.3-15) respectively (p = .21). Conclusions: In this cohort study, atezolizumab and breast cancer were significantly associated with increased risk of bleeding. The use of nivolumab was associated with a greater risk of thrombocytopenia after one month of treatment. Prospective studies are needed for better understanding of the hematological side effects of ICIs.

Factors at Admission That Are Predictive of Increased In-Hospital Bleeding in Acutely Ill Medical Patients: Findings from the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 264-264
Author(s):  
Hervé Decousus ◽  
Rainer B. Zotz ◽  
Victor F. Tapson ◽  
Beng H. Chong ◽  
James B. Froehlich ◽  
...  
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Univariate Analysis ◽  
Medical Illness ◽  
Medical Patients ◽  
Vte Prophylaxis ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Significant Difference ◽  
Clinically Significant

Abstract Background Although clinical studies have not shown a significant difference between the risk of bleeding in acutely ill medical patients receiving pharmacologic venous thromboembolism (VTE) prophylaxis and those receiving placebo, fear of bleeding may lead physicians to withhold pharmacologic prophylaxis for patients who should receive it. We therefore aimed to determine the incidence of, and risk factors for in-hospital bleeding in hospitalized acutely ill medical patients in IMPROVE, an international, observational registry. Methods Patients aged ≥18 years, hospitalized ≥3 days with an acute medical illness have been enrolled consecutively since July 2002. Exclusion criteria: therapeutic antithrombotics/thrombolytics at admission, major surgery or trauma during 3 months prior to admission, and VTE treatment within 24 hours of admission. Patients bleeding immediately before, or at admission were excluded from this analysis. Factors present at admission and associated with increased risk of in-hospital bleeding (defined as major or clinically significant nonmajor [Büller et al. N Engl J Med2003;349:1695–702]) were identified by univariate analysis (p&lt;0.15) and included in a multiple logistic regression model (significant at p&lt;0.05). The model was adjusted for patients’ length of stay in hospital. Results Data were from 5960 patients enrolled up to 31 March 2005 in 49 hospitals (12 countries). In-hospital bleeding occurred in 170 (2.9%) patients: 68 (1.1%) major and 102 (1.7%) clinically significant nonmajor bleeding. Independent risk factors for in-hospital bleeding are shown in the Table. In-hospital prophylaxis with low-molecular-weight and unfractionated heparin were not independently associated with an increased risk of bleeding when added to the analysis (p=0.51 and 0.38, respectively). In patients with 0, 1, 2 or ≥3 of these risk factors, the incidences of major in-hospital bleeding were 0.1%, 0.4%, 1.2% and 5.2%, respectively. Conclusions In this unselected patient population, the rate of major in-hospital bleeding was low (1.1%) and similar to that in the MEDENOX study (1.0%), a major clinical study of VTE prophylaxis. Factors that we identified will be valuable for predicting the risk of in-hospital bleeding in acutely ill medical patients. Table. Factors predictive of an increased risk of in-hospital bleeding in acutely ill medical patients Factor Odds ratio 95% confidence interval Active gastroduodenal ulcer 5.38 2.90–10.00 Bleeding disorder 4.54 2.02–10.19 Hepatic failure 3.34 1.80–6.19 Serum creatinine &gt;1.5 mg/dL 2.29 1.63-3.21 Current cancer 2.08 1.43-3.03 Central venous catheter 2.00 1.31-3.05 ICU/CCU stay 1.92 1.23-3.02 Immobile ≥ 4 days 1.75 1.24-2.46 Ischemic heart disease 1.57 1.02-2.40

The Incidence, Risk Factors, and Prognosis of Recurrent Venous Thromboembolism (VTE) in Patients with Advanced Solid Cancers Receiving Anticoagulation Therapy After the Diagnosis of Index Vte; A Korean Venous Thromboembolism Registry Study.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2247-2247
Author(s):  
Ho-Young Yhim ◽  
Moon Ju Jang ◽  
Won-Il Choi ◽  
Yong Cheol Lee ◽  
Jeong-Ok Lee ◽  
...  
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Anticoagulation Therapy ◽  
Tumor Site ◽  
Primary Tumor Site ◽  
Increased Risk ◽  
Recurrent Venous Thromboembolism ◽  
Independent Risk Factors ◽  
Recurrent Vte

Abstract Abstract 2247 Introduction Patients (pts) with cancer have been associated with increased risk of recurrent venous thromboembolism (VTE). However, few data are available regarding the recurrent VTE in Asian pts with advanced solid cancers. Thus, the aim of the study is to investigate the incidence and risk factors for recurrent VTE in pts with advanced solid cancers receiving anticoagulation therapy after index VTE. And, we also evaluate the prognostic impact of recurrent VTE on overall survival (OS) in this population. Methods This study was conducted using data from the web-based registry of the Korean Thrombosis Working Party (http://kdvt.chamc.co.kr), which is an ongoing, multicenter database for recruiting consecutive pts presenting with VTE. Pts were included in the study cohort if they had been diagnosed with recurrent/metastatic solid cancers between May 2004 and Dec 2011 and initiated anticoagulation therapy. Pts were excluded if they had received a diagnosis of hematologic malignancies, if solid cancers were not recurrent or metastatic disease, if index VTE was intra-abdominal venous thrombosis or vascular access-induced thrombosis, or if anticoagulation therapy was not instituted. Pts were also excluded if they were lost to follow-up within 1 week after initiating anticoagulation therapy. Maximal duration of anticoagulation therapy was 12 months and pts in whom anticoagulation therapy was stopped within 12 months were censored at the time of discontinuation. Results A total of 456 pts were included in this analysis. The median age was 65 (range, 27–91) years and 249 pts (55%) were male. Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 0 or 1 in 185 pts (41%). The primary sites of tumor were breast in 22 (5%), genito-urinary tracts in 38 (8%), esophago-gastric in 76 (17%), colo-rectum in 81 (18%), hepato-biliary tracts in 37 (8%), pancreas in 66 (15%), and lung in 136 (30%). Palliative chemotherapy was administered in 328 pts (72%). The location of index VTE was isolated pulmonary embolism (PE) in 196 (43%), isolated lower-extremity deep venous thrombosis (DVT) in 169 (37%), and concomitant PE and DVT in 91 (20%). For initial anticoagulation therapy, low molecular weight heparin was administered in 362 pts (79%), and for long-term therapy, 306 pts (75%) received warfarin. The median duration of anticoagulation therapy after index VTE was 2.4 (range, 0.1–58.3) months. The 6-months and 12-month cumulative incidences of recurrent VTE were 22.4% (95% CI, 19.4–25.4) and 28.7% (95% CI, 24.0–33.4), respectively. In the multivariate analysis for identifying the risk factors associated with the development of recurrent VTE, pancreas (HR, 6.12; 95% CI, 2.00–18.73) and lung (HR, 2.98; 95% CI, 1.03–8.58) as the primary tumor site, poor ECOG PS (HR, 1.74; 95% CI, 1.14–2.67) and VTE initially presented with PE (HR, 2.29; 95% CI, 1.17–4.47) were independent risk factors for increased risk of recurrent VTE. With a median follow-up of 29.1 (range, 1.0–91.2) months, median OS was 11.9 (95% CI, 10.2–13.6) months. Pts with recurrent VTE had a significantly shorter OS than those without recurrent VTE (median, 8.4 vs. 13.0 months, P<0.001). In the multivariate model, occurrence of recurrent VTE was independently associated with the increased risk of death (HR, 1.39; 95% CI, 1.03–1.88). Conclusion Although Asian populations are thought to have lower risk for developing recurrent VTE, our study demonstrates that the incidence of recurrent VTE in pts with advanced solid cancers is comparable to that of Western populations. Lung or pancreas as a primary tumor site, poor PS, and initial presentation with PE are independent risk factors for recurrent VTE. Additionally, survival is adversely affected by recurrent VTE. Further studies are needed to validate the results of our study and to optimize the treatment strategies for improving treatment outcomes in advanced cancer pts. Disclosures: No relevant conflicts of interest to declare.

Use Of Fondaparinux For Venous Thromboembolism Prophylaxis In Critically Ill Adult Patients With Moderate Renal Insufficiency

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4806-4806
Author(s):  
Anjan J Patel ◽  
Marc Zumberg ◽  
Jessica Cope ◽  
Jennifer Bushwitz ◽  
Abigail D Antigua
Keyword(s):  
Venous Thromboembolism ◽  
Renal Insufficiency ◽  
Dose Reduction ◽  
Critically Ill ◽  
Bleeding Events ◽  
Data Set ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Clinically Significant ◽  
Dose Reductions

Introduction Fondaparinux, a selective activated Factor Xa inhibitor, is a parenteral anticoagulant primarily excreted by the kidneys. Renal insufficiency (RI), commonly encountered in the critically ill, has been shown to portend an increased risk of bleeding than in normal healthy adults. In comparison to the low molecular weight heparin dalteparin, fondaparinux has been shown to be superior for the prevention of post-surgical venous thromboembolism (VTE), however an increased rate of nonfatal bleeding has been observed. Recently, data has emerged supporting empiric dose reductions in patients with moderate RI, defined as a creatinine clearance (CrCl) between 30 and 50 mL/min. Overall, the data supporting appropriate use of fondaparinux in patients with RI is lacking. This retrospective, single center study describes our experience using prophylactic fondaparinux in critically ill patients with moderate RI. Methods We report our experience utilizing fondaparinux in a mixed medical and surgical, critically ill adult population with moderate RI. The site examined was UF Health; an 852-bed sized tertiary care hospital in Gainesville, Florida between 2006 and 2012. Moderate RI was defined as a CrCl between 30 and 50 mL/min calculated by the Cockcroft/Gault equation. Only patients treated with fondaparinux for prophylaxis of VTE were included, patients treated for other indications were excluded. Doses, dose frequency and dose adjustments were documented. If patients had anti-Xa level monitoring these values were recorded. Timing of anti-Xa levels drawn with respect to fondaparinux dosing was also noted. The primary end point of the study was the rate of clinically significant bleeding events in patients receiving at least 72 hours of fondaparinux. Clinically significant bleeding was defined as transfusion of at least two units of packed red blood cells within 48 hours of a documented bleeding event or the workup of bleeding with endoscopy or imaging. Bleeding events were screened by ICD-9 codes and validated via chart review, incidence of VTE was also noted. Results Sixty-fourpatients met inclusion criteria between October 2006 and November 2012. Two patients (3.1%) experienced clinically significant bleeding events as per our definition, both in the form of gastrointestinal bleeding. Empiric dose reductions occurred in 8 (12.5%) patients, this occurred in the form of every other day administration or dose reduction using fondaparinux 1.25mg daily. Nine (14%) patients were monitored with anti-Xa levels, none of these patients encountered bleeding events. The median anti-Xa level was 0.5 mcg/mL, which is in the target prophylactic range for in our lab. The median time interval after last dose of fondaparinux to anti-Xa level measurement was 4 hours. Seven (10.9%) patients had VTE diagnoses prior to the initiation of prophylactic fondaparinux. No patients suffered a VTE event after treatment with prophylactic fondaparinux in our data set. Conclusion We report a cohort of patients with moderate RI receiving fondaparinux for the prevention of VTE. The incidence of clinically significant bleeding was 3.1%. The risk of VTE was low, no patients suffered from a VTE after treatment with fondaparinux in our data set. The rate of bleeding is slightly higher compared to patients with normal renal function. Our experience over this 6 year period supports the notion that RI portends an increased risk of bleeding with the use of fondaparinux. Further prospective studies are needed to determine the safety and efficacy of empiric fondaparinux dose reductions in patients with RI and end stage renal disease. Anti-Xa monitoring may help reduce the risk of bleeding in this patient population by identifying those patients in whom a dose reduction may be beneficial. Disclosures: No relevant conflicts of interest to declare.

Sign in / Sign up

Export Citation Format

Share Document