Sensitivity and specificity of an algorithm based on medico-administrative data to identify hospitalized patients with major bleeding presenting to an emergency department

Abstract Background Validation studies on an ICD-10-based algorithm to identify major bleeding events are scarce, and mostly focused on positive predictive values. Objective To evaluate the sensitivity and specificity of an ICD-10-based algorithm in adult patients referred to hospital. Methods This was a cross-sectional, retrospective analysis. Among all hospital stays of adult patients referred to Rennes University Hospital, France, through the emergency ward in 2014, we identified major bleeding events according to an index test based on a list of ICD-10 diagnoses. As a reference, a two-step process was applied: firstly, a computerized request for electronic health records from the emergency ward, using several hemorrhage-related diagnostic codes and specific emergency therapies so as to discard stays with a very low probability of bleeding; secondly, a chart review of selected records was conducted by a medical expert blinded to the index test results and each hospital stay was classified into one of two exclusive categories: major bleeding or no major bleeding, according to pre-specified criteria. Results Out of 16,012 hospital stays, the reference identified 736 major bleeding events and left 15,276 stays considered as without the target condition. The index test identified 637 bleeding events: 293 intracranial hemorrhages, 197 gastrointestinal hemorrhages and 147 other bleeding events. Overall, sensitivity was 65% (95%CI, 62 to 69), and specificity was 99.0%. We observed differential sensitivity and specificity across bleeding types, with the highest values for intracranial hemorrhage. Positive predictive values ranged from 59% for “other” bleeding events, to 71% (95%CI, 65 to 78) for gastrointestinal hemorrhage, and 96% for intracranial hemorrhage. Conclusions Low sensitivity and differential measures of accuracy across bleeding types support the need for specific data collection and medical validation rather than using an ICD-10-based algorithm for assessing the incidence of major bleeding.

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

Thrombosis and Haemostasis ◽

10.1055/a-1485-2372 ◽

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.

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

Thrombosis and Haemostasis ◽

10.1055/a-1477-3760 ◽

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.

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

Annales de biologie clinique ◽

10.1684/abc.2021.1658 ◽

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

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

10.21203/rs.3.rs-683341/v1 ◽

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.

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The safety of triple antiplatelet therapy under thromboelastography guidance in patients undergoing stenting for ischemic cerebrovascular disease

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-013987 ◽

2018 ◽

Vol 11 (4) ◽

pp. 352-356 ◽

Cited By ~ 6

Author(s):

Zhonghua Wu ◽

Ao-Fei Liu ◽

Ji Zhou ◽

Yiqun Zhang ◽

Kai Wang ◽

...

Keyword(s):

Antiplatelet Therapy ◽

Stent Thrombosis ◽

Major Bleeding ◽

Artery Stenosis ◽

Intracranial Artery ◽

Bleeding Events ◽

Triple Antiplatelet Therapy ◽

Intracranial Artery Stenosis ◽

Major Bleeding Events ◽

Group 1

ObjectiveTo investigate the safety of triple antiplatelet therapy (TAT) with cilostazol in patients undergoing stenting for extracranial and/or intracranial artery stenosis.MethodsA prospectively collected database was reviewed to identify patients who underwent stenting for extracranial and/or intracranial artery stenosis and showed resistance to aspirin and/or clopidogrel as assessed by pre-stenting thromboelastography (TEG) testing. Patients were assigned to a TAT group and a dual antiplatelet therapy (DAT) group. Major complications were defined as thromboembolic events (transient ischemic attack (TIA), ischemic stroke, and stent thrombosis) or major bleeding events within 30 days, and minor complications were defined as extracranial bleeding that did not require vascular surgery or transfusion within 30 days.ResultsA total of 183 patients were identified. The incidence of major complications was significantly lower in the TAT group than in the DAT group (TAT group vs. DAT group, 1/110 vs. 6/73; P=0.017). TIAs occurred in four patients, with one in the TAT group and three in the DAT group (1/110 vs. 3/73; P=0.303). Ischemic strokes occurred in three patients in the DAT group (TAT group vs. DAT group, P=0.062). No major bleeding events or stent thrombosis was recorded in either group. Two patients (one in each group) experienced minor complications that resolved without additional treatment (1/110 vs. 1/73; P>0.999).ConclusionsTAT under TEG guidance appears to be a safe antiplatelet strategy in patients undergoing stenting for extracranial and/or intracranial artery stenosis. By employing TAT under TEG guidance, favorable outcomes can be achieved in these patients.

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Abstract 17152: Frequency and Management of Major Bleeding in Atrial Fibrillation Patients Treated With Warfarin and Non-vitamin K Oral Anticoagulants in Community Practice: Results From the ORBIT-AF II Registry

Circulation ◽

10.1161/circ.132.suppl_3.17152 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Benjamin A Steinberg ◽

DaJuanicia N Simon ◽

Laine Thomas ◽

Jack Ansell ◽

Gregg C Fonarow ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Vitamin K ◽

Major Bleeding ◽

Oral Anticoagulants ◽

Recurrent Bleeding ◽

Bleeding Events ◽

Reversal Agents ◽

Major Bleeding Events

Background: Non-vitamin K oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the frequency of major bleeds on NOACs and how these events are managed in clinical practice. Methods: We assessed the rates, management, and outcomes of ISTH major bleeding events among AF patients in the ORBIT-AF II registry (mean follow-up 213 days). Results: Overall, 103 patients experienced 110 major bleeding events during follow-up n=90/4986 (1.8%) on NOAC, and n=20/1320 (1.5%) on warfarin. Patients with bleeding events on NOAC were slightly younger than those on warfarin (median age 76 vs. 80; p=0.2). Among mutually-exclusive bleeding types, intracranial bleeding was more common in warfarin treated patients than NOAC-treated (15% vs 6.7%), whereas GI bleeding was more common on NOACs (56% vs. 40%, overall p=0.1 for bleeding type). Management of bleeding differed by anticoagulation type: blood products and reversal agents were more commonly used in patients on warfarin (Table). No patient received prothrombin complexes, recombinant factor VIIa, aminocaproic acid, tranexamic acid, aprotinin, or desmopressin. Out of 90 major bleeding events in NOAC patients, only 1 was fatal (1%). Within 30 days following bleeding, there were no strokes and 1 TIA (NOAC). Following a major bleed, the recurrent bleeding rate in NOAC patients in the next 30-days was 4% and the death rate was 4%. Conclusions: Rates of major bleeding with NOACs in clinical practice are comparable to those reported in clinical trials. Compared with warfarin, bleeding among NOAC users was less likely intracranial and more likely to be GI. Management of bleeding in the setting of NOAC rarely includes reversal agents.

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Is increased fall risk a significant predictor of major bleeding events in patients on warfarin?

Evidence-Based Practice ◽

10.1097/01.ebp.0000540484.60365.38 ◽

2013 ◽

Vol 16 (10) ◽

pp. 8-9

Author(s):

Roman Zassoko ◽

Bachir Tazkarji

Keyword(s):

Major Bleeding ◽

Fall Risk ◽

Bleeding Events ◽

Major Bleeding Events

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Risk of major bleeding during extended oral anticoagulation in patients with first unprovoked venous thromboembolism: a systematic review and meta-analysis protocol

Systematic Reviews ◽

10.1186/s13643-019-1175-5 ◽

2019 ◽

Vol 8 (1) ◽

Cited By ~ 1

Author(s):

Faizan Khan ◽

Miriam Kimpton ◽

Tobias Tritschler ◽

Grégoire Le Gal ◽

Brian Hutton ◽

...

Keyword(s):

Systematic Review ◽

Venous Thromboembolism ◽

Anticoagulant Therapy ◽

Major Bleeding ◽

Oral Anticoagulation ◽

Meta Analysis ◽

Controlled Trials ◽

Bleeding Events ◽

Major Bleeding Events

Abstract Background The optimal duration of anticoagulation after a first unprovoked venous thromboembolism (VTE) remains controversial. Deciding to stop or continue anticoagulant therapy indefinitely after completing 3 to 6 months of initial treatment requires balancing the long-term risk of recurrent VTE if anticoagulation is stopped against the long-term risk of major bleeding if anticoagulation is continued. However, knowledge of the long-term risk for major bleeding events during extended anticoagulation in this patient population is limited. We plan to conduct a systematic review and meta-analysis to quantify the risk for major bleeding events during extended oral anticoagulation in patients with first unprovoked VTE. Methods Electronic databases including MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials will be systematically searched with the assistance of an information specialist (from inception to March 1, 2019) to identify randomized controlled trials and prospective cohort studies reporting major bleeding during extended oral anticoagulation in patients with first unprovoked VTE, who have completed at least 3 months of initial anticoagulant therapy. Study selection, risk of bias assessment, and data extraction will be performed independently by at least two investigators. The number of major bleeding events and person-years of follow-up will be used to calculate the rate (events per 100 person-years) with its 95% confidence interval for each study cohort, during clinically relevant time periods of extended anticoagulant therapy. Results will be pooled using random effect meta-analysis. Discussion The planned systematic review and meta-analysis will provide reliable estimates of the risk for major bleeding events during extended anticoagulation. This information will help inform patient prognosis and assist clinicians with balancing the risks and benefits of treatment to guide management of unprovoked VTE. Systematic review registration PROSPERO CRD42019128597.

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