Assessing the management of major bleeding events in patients treated by direct oral anticoagulant in an emergency department

2021 ◽  
Vol 79 (4) ◽  
pp. 315-324
Author(s):  
Julien Durand ◽  
Stéphanie Parat ◽  
Jean-Christophe Lega ◽  
Yessim Dargaud ◽  
Véronique Potinet ◽  
...  
Keyword(s):  
Emergency Department ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Direct Oral Anticoagulant ◽  
Bleeding Events ◽  
Major Bleeding Events

Role of Hypertension and Other Clinical Variables in Prognostication of Patients Presenting to the Emergency Department With Major Bleeding Events

2018 ◽  
Vol 17 (3) ◽  
pp. 139-146 ◽  
Author(s):  
Alberto Conti ◽  
Daniele Molesti ◽  
Simone Bianchi ◽  
Stefania Catarzi ◽  
Mariuccia Mazzucchelli ◽  
...  
Keyword(s):  
Emergency Department ◽  
Major Bleeding ◽  
Bleeding Events ◽  
Clinical Variables ◽  
Major Bleeding Events

scholarly journals Evaluation of Definitions for Oral Anticoagulant–Associated Major Bleeding: A Population-Based Cohort Study

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 426-426 ◽  
Author(s):  
Yan Xu ◽  
Tara Gomes ◽  
Philip S. Wells ◽  
Ana Johnson ◽  
Michelle Sholzberg
Keyword(s):  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Research Funding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Tertiary Care ◽  
Population Based ◽  
Bleeding Events ◽  
Risk Of Death ◽  
Major Bleeding Events

Abstract Background: Major bleeding is the most serious complication of oral anticoagulation. Consensus criteria to define major bleeding have been established by the International Society for Thrombosis and Haemostasis (ISTH), Bleeding Academic Research Consortium (BARC) and Thrombolysis in Myocardial Infarction (TIMI). Significant variability exists across these definitions, and their agreement for identifying oral anticoagulant (OAC) related major bleeding is unknown. Furthermore, the association between each definition and mortality in cases of OAC bleeding has not been evaluated. We therefore, sought to evaluate the agreement of cases identified as major bleeding by the ISTH, BARC and TIMI definitions, and to assess associated in-hospital (emergency department or inpatient) and 30-day mortality of cases identified by these criteria. Methods: We used an existing dataset of individuals ≥66 years in Ontario, Canada, who presented to one of five tertiary care institutions with OAC related bleeding across three cities from 2010-2015. Detailed clinical data on consecutive episodes of OAC-associated bleeding were linked to population-based databases held at the Institute for Clinical Evaluative Sciences. We calculated Cohen's κ for agreement between the three major bleeding definitions, and used Pearson's χ2 to determine any differences in in-hospital and 30-day mortality for cases defined as major bleeding by ISTH, BARC and TIMI criteria. Results: We included 2,002 cases of OAC related bleeding in the analysis (460 on direct oral anticoagulants, 1,542 on warfarin). ISTH, BARC and TIMI major bleeding definitions were met in 75%, 77% and 29% of cases, respectively. 18% of cases did not meet criteria for major bleeding by any definition. Age, sex, CHA2DS2-VASc and HAS-BLED score, as well as proportion of chronic kidney disease were similar across ISTH-, BARC- and TIMI-defined cases. Over 9 in 10 cases of TIMI-defined major bleeding events involved an intracranial hemorrhage (94.4%), compared to 37% and 36% of cases identified by ISTH or BARC definitions respectively (p<0.001 across three groups). Agreement in case identification between ISTH and BARC was substantial (agreement 89%; Cohen's κ=0.69). On the other hand, agreement between TIMI and both ISTH (agreement 54%; Cohen's κ =0.24) and BARC (agreement 52%; Cohen's κ=0.21) were poor. The association between in-hospital mortality and TIMI-defined major bleeding was higher (29%) than that for ISTH and BARC (17% for both; p<0.001 for TIMI vs. ISTH and TIMI vs. BARC). The association with 30-day mortality showed a similar trend (30%, 18% and 18% for TIMI-, ISTH- and BARC- defined major bleeding events respectively; p<0.001 for TIMI vs. ISTH and TIMI vs. BARC). 6% of cases that were not categorized as major bleeding by ISTH or BARC definitions died within 30 days of hospital presentation, and this was 10% for cases not meeting criteria for TIMI major bleeding (10%, p=0.036 by Pearson's χ2). Conclusions: Among patients with OAC-associated bleeding, major bleeding events identified by ISTH and BARC criteria showed good agreement and similar prognostic utility. Meanwhile, TIMI criteria identified patients with higher clinical risk and subsequent mortality. Patients presenting with OAC-associated bleeding who did not fulfill ISTH or BARC major bleeding criteria had considerable risk of 30-day mortality and was even higher among those not meeting the TIMI criteria. Our findings suggest the need to refine current major bleeding definitions to identify additional patients at risk of death. Disclosures Wells: Bayer: Honoraria; BMS: Honoraria, Research Funding; Sanofi: Honoraria; Janssen: Honoraria. Sholzberg:Amgen: Research Funding; CSL Behring: Research Funding; Octapharma: Research Funding; Shire: Research Funding.

scholarly journals Effectiveness of the Alfalfa App in Warfarin Therapy Management for Patients Undergoing Venous Thrombosis Prevention and Treatment: A Cohort Study (Preprint)

2020 ◽  
Author(s):  
Hua Cao ◽  
Shaojun Jiang ◽  
Meina Lv ◽  
Tingting Wu ◽  
Wenjun Chen ◽  
...  
Keyword(s):  
Emergency Department ◽  
Cohort Study ◽  
Major Bleeding ◽  
Hospital Admissions ◽  
Point Of Care ◽  
Emergency Department Visits ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Anticoagulation Management ◽  
Major Bleeding Events

BACKGROUND In the past years, the internet has enabled considerable progress in the management of chronic diseases, especially hypertension and diabetes. And it also provides novel opportunities in online anticoagulation management. Nevertheless, there is insufficient evidence regarding the effectiveness of online anticoagulation management. OBJECTIVE This study explored the effectiveness and safety of warfarin management via the Alfalfa app, so as to provide evidence in support of anticoagulant management through online services. METHODS In this retrospective, observational cohort study, 824 patients were included. In the offline group, patients went to the hospital clinic for warfarin management. In the Alfalfa app group, patients reported the dose of warfarin, current INR value and other related information through the Alfalfa app. Physicians or pharmacists used the app to adjust the dose of warfarin and determined the time for the next blood INR testing. Patients completed INR testing by point-of-care at home or hospital. The primary outcome of the study was the percentage of time in therapeutic range (TTR). Secondary outcomes included minor and major bleeding events, thrombotic events, warfarin-related emergency department visits, hospital admissions, and high INR values. RESULTS TTR and percentage of INR values in the range were significantly higher in the Alfalfa app than in the offline (79.35% vs. 52.38%, P < .001; 77.39% vs. 47.72%, P < .001, respectively). Patients managed via the Alfalfa app had lower rate of subtherapeutic (4.02% vs. 9.23%, P < .001), supratherapeutic (11.37% vs. 20.99%, P < .001), and extreme subtherapeutic INR values (6.77% vs. 21.66%, P < .001). Additionally, the Alfalfa app had lower incidences of major bleeding (0.47% vs. 3.01%, P = .005), warfarin-related emergency department visits (3.06% vs. 9.07%, P < .001), and hospital admissions (0.24% vs. 3.01%, P = .001) compared with the offline. However, the Alfalfa app had higher incidences of minor bleeding than the offline (10.59% vs. 5.01%, P = .003). There were similar incidences in extreme supratherapeutic INR values (0.44 %vs. 0.40%, P = .782) and thromboembolic events (0.24% vs. 0.25%, P = .964) between the two groups. CONCLUSIONS Warfarin management is superior via Alfalfa app than via offline services in terms of major bleeding events, warfarin-related emergency department visits, and hospital admissions. CLINICALTRIAL

scholarly journals FEIBA™ for Reversal of Direct Oral Anticoagulant Associated Major Bleeding

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1540-1540
Author(s):  
Joseph Shaw ◽  
Gregoire Le Gal ◽  
Melanie Tokessy ◽  
Nancy Cober ◽  
Elianna Saidenberg ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Vitamin K ◽  
Major Bleeding ◽  
Conservative Management ◽  
Oral Anticoagulant ◽  
Direct Oral Anticoagulant ◽  
Bleeding Events ◽  
Life Threatening ◽  
Bleeding Episodes

Abstract Introduction: Direct oral anticoagulants (DOACs) are indicated for the prevention of systemic embolism in patients with atrial fibrillation and for the prevention and treatment of venous thrombosis. Although DOACs offer advantages over the vitamin K antagonists, some hesitancy remains over their use given the lack of specific antidotes for management of life threatening bleeding events. In vivo studies, case reports and case series have shown that prothrombin complex concentrate (PCC) and activated PCC might potentially be used to control life threatening bleeding in patients with DOAC-associated bleeding episodes. Herein we describe management and outcomes of DOAC-associated life threatening bleeding events using an activated PCC (FEIBA™). Methods: A retrospective review of patients presenting with DOAC-associated (dabigatran, rivaroxaban or apixaban) life threatening bleeding to The Ottawa Hospital between January 2013 and June 2014 are included. Patients received 25 – 50 units/kg of FEIBA™. The primary outcome was adverse thrombotic and embolic events during follow-up. Secondary outcome was symptomatic control of bleeding. Results: Nine patients presented to hospital with life threatening bleeding episodes (post trauma: n=3; spontaneous bleeding: n=6). Spontaneous episodes included epistaxis or gastro-intestinal bleeding. Baseline characteristics are depicted in Table 1. A majority of patients had atrial fibrillation (n=8) and received rivaroxaban (n=5). The last dose of DOAC was taken within 24 hours of bleeding events for all patients. All patients received supportive management, interventions/procedures aimed at attaining source control of bleeding when possible, and transfusion of FEIBA™ for reversal of anticoagulant effect. Adverse events after receiving FEIBA™ were uncommon with one patient experiencing a TIA with expressive aphasia and visual field deficit on the evening of FEIBA™ transfusion; deficits resolved by the time of hospital discharge. Two patients with GI bleeding continued to have ongoing bleeding despite FEIBA™ administration and two patients died as a result of major bleeding. Conclusions: In this cohort of patients with major bleeding associated with DOACs, FEIBA™ administration, in addition to supportive care, was helpful in minimizing further complications of most bleeding events and associated with a low rate of adverse events. Prospective studies are needed to evaluate benefits and harms of FEIBA™ for management of DOAC associated major bleeding. Abstract 1540. Table 1: Patients with Life-threatening Bleeding Patient (Age and Gender) Indication for DOAC [AF(CHADS2); VTE] DOAC and Dosage Site of Bleeding Intervention/ Procedure Units of PRBCs Transfused Additional Treatment FEIBA™ Dose (IU)(1st/2nd) Adverse Events post-FEIBA™ Administration Survived Hospitalization 85 Male AF (2) Rivaroxaban 20 mg daily Epistaxis Nasal Packing 0 -- 3275 -- Yes 86 Male AF (2) Rivaroxaban 20 mg daily LGIB Angiogram, no embolization performed 10 Vitamin K 3159/ 2952 -- Yes 84 Male AF (2) Dabigatran 110 mg BID Orbital vitreous hemorrhage Surgical repair of ruptured globe 0 -- 1812 -- Yes 92 Male AF (6) Apixaban 5 mg BID Left hand Conservative management 1 Tranexamic acid 2718 TIA Yes 85 Male VTE Rivaroxaban 20 mg daily LGIB Conservative management 2 Vitamin K 1740 -- Yes 90 Female AF (5) Rivaroxaban 20 mg daily SDH Conservative management 0 -- 3275 -- No; died of major bleed 93 Female AF (6) Apixaban 2.5 mg BID LGIB Conservative management 4 -- 2241 -- No 93 Male AF (3) Rivaroxaban 15 mg daily UGIB Upper endoscopy, no intervention 4 Vitamin K 3000 -- No; died of major bleed and septic shock 81 Male AF (4) Dabigatran 110 mg BID LGIB Upper endoscopy and colonoscopy, no interventions 4 -- 3362 -- No AF = atrial fibrillation; BID = twice daily; CHADS = congestive heart failure, hypertension, age, diabetes, stroke; DOAC = direct oral anticoagulant; IU = international units; LGIB = lower gastrointestinal bleeding; PRBC = packed red blood cells; SDH = subdural hematoma; TIA = transient ischemic attack; UGIB = upper gastrointestinal bleeding; VTE = venous thromboembolism Disclosures Off Label Use: FEIBA is an activated prothrombin complex concentrate that was used during management of life threatening bleeding in patients with direct oral anticoagulant-associated bleeding episodes..

scholarly journals Intermediate vs Standard-dose Prophylactic Anticoagulation in Patients with COVID-19 Admitted to ICU: Ninety-day Results from the INSPIRATION Trial

2021 ◽  
Author(s):  
Behnood Bikdeli ◽  
Azita H Talasaz ◽  
Farid Rashidi ◽  
Hooman Bakhshandeh ◽  
Farnaz Rafiee ◽  
...  
Keyword(s):  
Hospital Discharge ◽  
Major Bleeding ◽  
Arterial Thrombosis ◽  
Dose Group ◽  
Standard Dose ◽  
Controlled Trial ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
Prophylactic Anticoagulation ◽  
Intermediate Dose

Background: Thrombotic complications are considered among the main extrapulmonary manifestations of COVID-19. The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. Methods: This manuscript reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. Results: Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]; 62 (50, 71) years; 237 (42.2%) women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate-dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95-1.55, P=0.11). No significant differences were observed between the two groups for other efficacy outcomes, or in the landmark analysis from days 31-90. Overall, there were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53-6.24, P=0.33). Conclusion: Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up.

A Systematic Review of Anticoagulation Strategies for Patients With Atrial Fibrillation in Critical Care.

2021 ◽  
Author(s):  
Alexandra Jayne Nelson ◽  
Brian W Johnston ◽  
Alicia Achiaa Charlotte Waite ◽  
Gedeon Lemma ◽  
Ingeborg Dorothea Welters
Keyword(s):  
Atrial Fibrillation ◽  
Critical Care ◽  
Critically Ill ◽  
Major Bleeding ◽  
Critically Ill Patients ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
The Impact ◽  
Anticoagulated Patients

Background. Atrial fibrillation (AF) is the most common cardiac arrhythmia in critically ill patients. There is a paucity of data assessing the impact of anticoagulation strategies on clinical outcomes for general critical care patients with AF. Our aim was to assess the existing literature to evaluate the effectiveness of anticoagulation strategies used in critical care for AF. Methodology. A systematic literature search was conducted using MEDLINE, EMBASE, CENTRAL and PubMed databases. Studies reporting anticoagulation strategies for AF in adults admitted to a general critical care setting were assessed for inclusion. Results. Four studies were selected for data extraction. A total of 44087 patients were identified with AF, of which 17.8-49.4% received anticoagulation. The reported incidence of thromboembolic events was 0-1.4% for anticoagulated patients, and 0-1.3% in non-anticoagulated patients. Major bleeding events were reported in three studies and occurred in 7.2-8.6% of the anticoagulated patients and up to 7.1% of the non-anticoagulated patients. Conclusions. There was an increased incidence of major bleeding events in anticoagulated patients with AF in critical care compared to non-anticoagulated patients. There was no significant difference in the incidence of reported thromboembolic events within studies, between patients who did and did not receive anticoagulation. However, the outcomes reported within studies were not standardised, therefore, the generalisability of our results to the general critical care population remains unclear. Further data is required to facilitate an evidence-based assessment of the risks and benefits of anticoagulation for critically ill patients with AF.

scholarly journals Concurrent Use of Chinese Herbal Medicine and Anticoagulants May Reduce Major Bleeding Events

2021 ◽  
Author(s):  
Shuo-Min Hsu ◽  
Hung-Jen Lin ◽  
Yi-Wei Kao ◽  
Te-Mao Li ◽  
Ben-Chang Shia ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Major Bleeding ◽  
Lower Risk ◽  
Panax Notoginseng ◽  
Research Database ◽  
Bleeding Events ◽  
Chinese Herbal ◽  
Concurrent Use ◽  
Major Bleeding Events

Abstract Background: This retrospective cohort study investigated the risk of major bleeding events during the concurrent use of Chinese herbal medicine (CHM) and anticoagulants in clinical practice. Methods: A total of 4,470 patients receiving anticoagulant drugs were selected from Taiwan’s National Health Insurance Research Database (NHIRD). Half (n=2,235) were also using CHMs (CHM cohort); the other half were not (non-CHM cohort). Each cohort was matched 1:1 using the propensity score. Chi-square testing and the Student’s t-test were used to examine differences between two cohorts. Cox proportional hazard regression analysis assessed the risks for major bleeding events in each cohort, as well as bleeding risks associated with specific CHM formulas and herbs. Cumulative incidence curves for major bleeding events were calculated using Kaplan-Meier analysis. Results: Compared with the non-CHM cohort, the CHM cohort had a lower risk of overall bleeding events (p < 0.001) including hemorrhagic stroke (p = 0.008), gastrointestinal (GI) bleeding (p < 0.001), urogenital bleeding (p ≤ 0.001) and nasal/ear/eye bleeding (p = 0.004). Single herbs, such as Glycyrrhiza uralensis et Rhizoma, Panax notoginseng, Panax ginseng, Platycodon grandiflorum, Eucommia ulmoides Oliver and formulas, such as Shu Jing Huo Xue Tang, Shao Yao Gan Cao Tang and Ji Sheng Shen Qi Wan were associated with a lower risk of major bleeding events. Conclusions: Using CHMs with anticoagulants appeared to decrease the risk of major bleeding. Further investigations are needed to determine whether CHM can maintain the therapeutic efficacy of anticoagulants while simultaneously reducing potential side effects.Trial registration: Not applicable.

A single center retrospective cohort study comparing low-molecular-weight heparins to direct oral anticoagulants for the treatment of venous thromboembolism in patients with cancer – A real world experience

2018 ◽  
Vol 25 (4) ◽  
pp. 793-800 ◽  
Author(s):  
Megan K Phelps ◽  
Tracy E Wiczer ◽  
H Paige Erdeljac ◽  
Kelsey R Van Deusen ◽  
Kyle Porter ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Low Molecular Weight Heparin ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Low Molecular Weight ◽  
Direct Oral Anticoagulant ◽  
Recurrent Cancer ◽  
Cancer Associated Thrombosis

Introduction Low-molecular-weight heparins are the standard treatment for cancer-associated thrombosis. Recently, direct oral anticoagulants are a new option for thrombosis treatment; however, data supporting the use of direct oral anticoagulants for cancer-associated thrombosis are limited. Objectives The primary objective of this study was to determine the rate of recurrent cancer-associated thrombosis and major bleeding within 6 months of starting either low-molecular-weight heparin or direct oral anticoagulant for treatment of cancer-associated thrombosis. Secondary objectives were to determine the rates of clinically relevant-non-major bleeding and all-cause mortality. Patients/methods This is a retrospective cohort study including adults with cancer-associated thrombosis treated with low-molecular-weight heparin or direct oral anticoagulant between 2010 and 2016 at the Ohio State University. Medical records were reviewed for 6 months after initiation of anticoagulation or until the occurrence of recurrent cancer-associated thrombosis, major bleeding, cessation of anticoagulation of interest, or death, whichever occurred first. Results Four hundred and eighty patients were included (290 low-molecular-weight heparin and 190 direct oral anticoagulant). Patients treated with direct oral anticoagulant were found to carry “lower risk” features including cancer with lower VTE risk and lower rate of metastatic disease. After adjustment for baseline differences, there was no significant difference in the rate of recurrent cancer-associated thrombosis (7.2% low-molecular-weight heparin vs 6.3% direct oral anticoagulant, p = 0.71) or major bleeding (7.6% low-molecular-weight heparin vs 2.6% direct oral anticoagulant, p = 0.08). Conclusions Our study demonstrates that in a select population of cancer patients with VTE, direct oral anticoagulant use can be as effective and safe compared to the standard therapy with low-molecular-weight heparin.

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