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

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

Clinical impact of chemotherapy-induced thrombocytopenia in patients with gynecologic cancer.

1994 ◽  
Vol 12 (11) ◽  
pp. 2317-2320 ◽  
Author(s):  
G L Goldberg ◽  
D G Gibbon ◽  
H O Smith ◽  
C DeVictoria ◽  
C D Runowicz ◽  
...  
Keyword(s):  
Platelet Count ◽  
Major Bleeding ◽  
Gynecologic Cancer ◽  
Minor Bleeding ◽  
Clinical Effects ◽  
Bleeding Events ◽  
Transfusion Therapy ◽  
Platelet Counts ◽  
Major Bleeding Events ◽  
Platelet Transfusions

PURPOSE AND METHODS This retrospective analysis of 501 patients with gynecologic cancer treated with chemotherapy evaluates the relationship between platelet count and clinical bleeding, as well as the clinical effects of platelet transfusion therapy. Thrombocytopenic patients were divided into six groups according to platelet counts, and major or minor bleeding manifestations were documented. Thrombocytopenia was defined as a platelet count less than 100,000/microL. RESULTS Thrombocytopenia occurred in 182 (36.3%) patients over 808 of 1,546 chemotherapy cycles (52%). No intracranial or life-threatening bleeding occurred in any patient. The majority of patients (139 [76.4%]) had no clinical bleeding. Minor bleeding, such as purpura, occurred in 34 patients (18.7%) and 44 cycles (5.4%). Major bleeding occurred in nine patients (4.9%) and 10 cycles (1.3%). Five major bleeding events occurred in 49 patients with platelet counts between 0 and 10,000/microL. Forty-three of these patients received platelet transfusions. Thirty-eight of 43 transfused patients (88.3%) had no bleeding. Of the remaining five patients, two were transfused prophylactically with no effect. Three major bleeding events occurred in patients with platelet counts that ranged from 11,000 to 20,000/microL, but these were due to chronic instrumentation or trauma. In patients with platelet counts more than 20,000/microL, major bleeding occurred only from necrotic metastatic lesions. Random-donor platelet transfusions provided inconsistent increments in platelet counts. Overall, 27.5% of patients achieved the expected increase in platelet number based on units of platelet concentrate transfused. The use of single-donor or human leukocyte antigen (HLA)-matched platelets did not provide greater increments in those patients who were refractory to random-donor platelets. CONCLUSION Platelet counts > or = 10,000/microL are not associated with spontaneous major bleeding. Prophylactic platelet transfusions in patients with gynecologic malignancies and chemotherapy-induced thrombocytopenia should be limited to those with platelet counts < or = 10,000/microL, provided they are not bleeding and have no major anatomic or pathophysiologic precursors of bleeding.

Increased Incidence of Major Bleeding in Children Receiving Unfractionated Heparin for Clinical Management: A Prospective Cohort Study.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1772-1772 ◽  
Author(s):  
Lesley G. Mitchell ◽  
Stefan Kuhle ◽  
Patricia M. Massicotte ◽  
Patricia Vegh
Keyword(s):  
Cohort Study ◽  
Unfractionated Heparin ◽  
Prospective Cohort Study ◽  
Major Bleeding ◽  
Prospective Cohort ◽  
Recurrent Thrombosis ◽  
Heparin Dose ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
Relationship Of

Abstract BACKGROUND: Unfractionated heparin (UFH) is one of the most frequently prescribed drugs in paediatric tertiary care centres and is used in a diverse group of disorders including cardiopulmonary bypass, extra corporeal membrane oxygenation, dialyses and maintenance of both venous and arterial catheter patency. Dosing of UFH in children is extrapolated from adults and is assessed by either a chromogenic Anti-Xa assay or a clot-based activated partial thromboplastin time (aPTT). The overall objective of the study was to assess safety of current standard of practice in the use of therapeutic UFH in children. Objective #1: The primary objective was to determine the incidence of bleeding and the incidence of recurrent thrombosis in children receiving UFH. Objective #2: To assess the monitoring UFH by assessing the relationship of the aPTT and Anti-Xa heparin levels to heparin dose. STUDY DESIGN: A prospective cohort study in nonselected children in a intensive care setting. The primary outcomes were major bleeding events and recurrent thrombosis. The secondary outcomes were assessing the APTT and Anti-Xa levels. Inclusion Criteria: Patients 〉 36 weeks gestation and 〈18 years of age requiring therapeutic doses of UFH. Exclusion Criteria: patients who received UFH for less than 1 day. Major bleeding was defined aprior as any of the following: CNS bleeding, retroperitoneal bleeding, and/or bleeding that results in stopping UFH infusion. RESULTS: Patient Population 39 patients were enrolled, 22 (56%) male, 32 (82%) < 1 year of age and 90% of which where cardiac patients. Major Bleeding events: 11/39 patients had a major bleeding event 28.2% (95% CI 15.0–44.9%). No patient had recurrent thrombosis. Relationship of aPPT and Anti-Xa to heparin dose; A total of 188 paired aPTTs and anti-Xa levels were performed. There was little correlation between aPTT and anti-Xa levels (r2=0.205) and APTT and UFH dose (r2=0.054). There was no relationship between anti-Xa levels and UFH dose (r2=0.0089). (Figure 1 and 2) Figure Figure CONCLUSIONS:. There is an unacceptably high rate of bleeding in children receiving UFH for clinical care. There is little or no relationship of aPPT and Anti-Xa to heparin dose. Clinical trials are needed to assess the appropriate use of UFH therapy in children.

Calculation of HAS-BLED Score Is Useful for Early Identification of Venous Thromboembolism Patients at High Risk for Major Bleeding Events: A Prospective Outpatients Cohort Study

2017 ◽  
Vol 44 (04) ◽  
pp. 348-352 ◽  
Author(s):  
Reinhard Raggam ◽  
Franz Hafner ◽  
Alexander Avian ◽  
Gerald Hackl ◽  
Gerhard Cvirn ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Odds Ratio ◽  
Bleeding Complications ◽  
Minor Bleeding ◽  
Prospective Evaluation ◽  
Bleeding Events ◽  
Increased Risk ◽  
Major Bleeding Events

AbstractThe aim of this study was prospective evaluation of the performance of the HAS-BLED score in predicting major bleeding complications in a real-world outpatient cohort, during long-term anticoagulation for venous thromboembolism (VTE), treated with a broad spectrum of anticoagulants. We analyzed 111 outpatients objectively diagnosed with VTE and treated long-term with various anticoagulants. Patients were grouped in three cohorts based on the anticoagulant regimen. Calculation of the HAS-BLED score and documentation of bleeding events were performed every 6 months for 1 year. Patients with a HAS-BLED score ≥ 3 had an increased risk for major bleeding events (odds ratio [OR]: 13.05, 95% confidence interval [CI]: 0.96–692.58, p = 0.028) and a trend to higher risk for minor bleeding events as well (OR: 2.25, 95% CI: 0.87–5.85, p = 0.091) when compared with patients with a HAS-BLED score < 3.This indicates that a HAS-BLED score ≥ 3 allows for identification of patients with VTE on long-term anticoagulation at an increased risk for major bleeding events, irrespective of the anticoagulant agent used.

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 Bleeding management in computed tomography-guided liver biopsies by biopsy tract plugging with gelatin sponge slurry

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Nikolaus A. Handke ◽  
Dennis C. Koch ◽  
Eugen Muschler ◽  
Daniel Thomas ◽  
Julian A. Luetkens ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Liver Biopsy ◽  
Adverse Events ◽  
Major Bleeding ◽  
Odds Ratio ◽  
Gelatin Sponge ◽  
Minor Bleeding ◽  
Safe Procedure ◽  
Bleeding Events ◽  
Major Bleeding Events

AbstractTo evaluate the safety and impact of biopsy tract plugging with gelatin sponge slurry in percutaneous liver biopsy. 300 consecutive patients (158 females, 142 males; median age, 63 years) who underwent computed tomography-guided core biopsy of the liver in coaxial technique (16/18 Gauge) with and without biopsy tract plugging were retrospectively reviewed (January 2013 to May 2018). Complications were rated according to the common criteria for adverse events (NCI-CTCAE). The study cohort was dichotomized into a plugged (71%; n = 214) and an unplugged (29%; n = 86) biopsy tract group. Biopsy tract plugging with gelatin sponge slurry was technically successful in all cases. Major bleeding events were only observed in the unplugged group (0.7%; n = 2), whereas minor bleedings (4.3%) were observed in both groups (plugged, 3.6%, n = 11; unplugged, 0.7%, n = 2). Analysis of biopsies and adverse events showed a significant association between number of needle-passes and overall (P = 0.038; odds ratio: 1.395) as well as minor bleeding events (P = 0.020; odds ratio: 1.501). No complications associated with gelatin sponge slurry were observed. Biopsy tract plugging with gelatin sponge slurry is a technically easy and safe procedure that can prevent major bleeding events following liver biopsy.

scholarly journals Efficacy and Safety of Direct Oral Anticoagulants in Obese Patients with Venous Thromboembolism

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3675-3675
Author(s):  
Renata Almeida Sa ◽  
Fatimah Al-Ani ◽  
Alejandro Lazo-Langner ◽  
Martha L Louzada
Keyword(s):  
Body Weight ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Minor Bleeding ◽  
Obese Patients ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Major Bleeding Events

Background: Obesity is a well-known risk factor for venous thromboembolism (VTE), however, obese patients are under-represented in clinical trials (1;2). Four direct oral anticoagulants (DOACs) have been approved for the treatment of acute VTE (3-6), including the direct Factor Xa inhibitors rivaroxaban, apixaban and edoxaban and the direct thrombin inhibitor, dabigatran. Given the lack of data in this population, it is unclear if DOACs can be used safely. Objectives: To evaluate the efficacy and safety of DOACs for the treatment of VTE in obese patients. Methods: We conducted a retrospective, single-centre cohort study in London (Canada) to compare the efficacy and safety of DOACs for the treatment of acute VTE in obese patients. We screened electronic and hard copy charts of adult patients referred to our thrombosis clinic for treatment of an objectively confirmed acute VTE between January 2012 and December 2017. Patients treated with DOACs or Warfarin were selected and followed from diagnosis of the index event until cessation of anticoagulation or up to 1 year. Our study population was analyzed by BMI (BMI ≥ 30 kg/m2versus &lt; 30 kg/m2) and body weight (≥120 kg vs. &lt;120 kg). Patients were excluded if they were on anticoagulation therapy for conditions other than VTE (e.g; atrial fibrillation), cancer-associated thrombosis, or missing data. The primary outcome measure was VTE recurrence during the anticoagulation treatment period and was defined according to the ISTH criteria (7). Our secondary outcome was the occurrence of bleeding events A bleeding event is defined as: a) Major Bleeding: bleed resulting in a hemoglobin drop of &gt; 20 g/L, clinically overt and requiring more than 2 units of packed red blood cells, a hemorrhage requiring permanent cessation of anticoagulation and any retroperitoneal or intracranial hemorrhage; b) Minor Bleeding: bleed with no or little clinical significance, associated with no cost and does not require medical evaluation; and c) clinically significant non-major bleeding: does not fulfill criteria for major or minor bleeding but requires patients to be seek medical attention and/or minor procedures (8). Groups were compared using Chi-square or Fisher's exact test for categorical variables, as appropriate. The significance level was set at 0.05. Risk ratios (RR) and 95% confidence intervals (95% CI) for VTE recurrence and bleeding among DOAC groups and patients treated with Warfarin were analyzed by logistic regression. All statistical analyses were conducted using IBM SPSS Statistics version 25 (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.). Results: Of 1143 potentially eligible patients, 777 fulfilled our inclusion criteria: 278 (35.8%) obese patients treated with DOACs, 266 (34.2%) non-obese patients on DOACS and 233 (30%) obese patients on Warfarin. Of the patients on DOACs, 80% (n= 436) were on rivaroxaban, while the remaining 20% were either on apixaban or edoxaban (n= 108). Among patients on DOACs VTE recurrence was observed in 2.1% (N=6) of patients with BMI ≥ 30 kg/m2 and 2.8% (N=2) of patients with 120 kg or more, with no differences in the risk of VTE recurrence (Table 1). The proportion of major bleeding events for patients on DOACs was 1.1% (N=3) for patients with BMI ≥ 30 kg/m2 and 1.4% (N=1) for patients with 120kg or more. There were no significant differences with respect to major and total bleeding risk (Table1). When comparing obese patients on DOACs vs Warfarin we did not find differences in the risk of VTE recurrence among patients with a BMI ≥ 30 kg/m2 [RR 2.59 95% IC (0.51-12.96), p= 0. 247] or body weight ≥120 kg [RR 4.33 95% IC (0.21-89.43), p= 0. 337] (Table 2). Among obese patients those treated with DOACs had a similar proportion and risk of total bleeding and major bleeding events compared to those on warfarin (Table 2). Conclusions: Our retrospective study suggests that DOACs at standard doses appear to have similar efficacy and safety in obese patients as defined herein. However, since most of our patients were treated with rivaroxaban, information on other agents is inconclusive. Information on patients with extreme body weight was limited. Disclosures Louzada: Bayer: Honoraria; Janssen: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria.

scholarly journals Direct Oral Anticoagulants (DOACs) Vs. Low Molecular Weight Heparins (LMWH) for Venous Thromboembolism (VTE) in Patients with Primary Brain Tumors or Secondary Brain Metastases

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 6-6 ◽  
Author(s):  
Angela Lee ◽  
Frank Oley ◽  
Mimi Lo ◽  
Richard Fong ◽  
Mary McGann ◽  
...  
Keyword(s):  
Cohort Study ◽  
Brain Tumors ◽  
Brain Metastases ◽  
Major Bleeding ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Minor Bleeding ◽  
Bleeding Events ◽  
Primary Brain Tumors ◽  
Recurrent Vte

Background: Management of venous thromboembolism (VTE) in patients with central nervous system (CNS) malignancies is challenging as there is an increased risk of recurrent VTE and intracranial hemorrhage (ICH). Low molecular weight heparins (LMWH) have historically been the standard of care for treatment of cancer-associated thrombosis (CAT). Current guidelines recommend direct oral anticoagulants (DOACs) for CAT treatment, but patients with CNS malignancies have limited representation in the supporting clinical trials. This multicenter, retrospective cohort study evaluated the safety and efficacy of DOACs compared to LMWH for CAT in patients with primary brain tumors or secondary brain metastases. Patients/Methods: In this multicenter, retrospective cohort study, adult patients with a diagnosis of primary brain tumor or secondary brain metastases who received either a DOAC or LMWH for CAT were evaluated. The primary outcome was the incidence of any bleeding event within a 6-month period following the initiation of anticoagulation. Secondary outcomes included incidence of recurrent VTE events, major bleeding, clinically relevant non-major bleeding (CRNMB), and minor bleeding, within a 6-month period following the initiation of anticoagulation. Patients were excluded if their indication for anticoagulation was stroke, non-cancer-associated VTE, or VTE prophylaxis, were on LMWH for one week or less while bridging to warfarin, or received a diagnosis of VTE at an outside hospital. All bleeding events were defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria. Primary and secondary outcomes were analyzed using Fisher's exact test for categorical variables and Wilcoxon rank-sum tests for non-parametric continuous variables. Results: Between January 1, 2012 to October 9, 2019, one-hundred eleven patients met inclusion criteria. Of the patients who met inclusion criteria, 26 (23.4%) patients had primary brain tumors and 85 (76.6%) patients had secondary brain metastases. Bleeding events occurred in 7 of 55 patients (12.7%) in the DOAC group compared to 13 of 56 (23.2%) patients in the LMWH group (RR 0.55, 95% CI 0.24-1.27). Recurrent VTE events occurred in 3 of 55 (5.5%) patients in the DOAC group compared to 3 of 56 (5.4%) patients in the LMWH group (RR 1.02, 95% CI 0.21-4.83). Major bleeding occurred in 3 of 55 (5.5%) patients in the DOAC group, compared to 4 of 56 (7.1%) patients in the LMWH group (RR 0.76, 95% CI 0.18-3.26). There were no differences in the rates of CRNMB and rates of minor bleeding between groups. Conclusion: In this multicenter retrospective cohort study, therapeutic anticoagulation with DOACs showed no significant difference in bleeding events or recurrent VTE events when compared to LMWH, in patients with primary brain tumors or secondary brain metastases. We conclude that DOACs may be potentially safe and efficacious for VTE treatment in patients with primary brain tumors or secondary brain metastases. As prescribing practices are expected to continue to shift towards DOACs, this study provides preliminary evidence of the safety of DOACs in this high-bleeding risk patient population. Disclosures No relevant conflicts of interest to declare.

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