scholarly journals Patient Harm from Repetitive Blood Draws and Blood Waste in the ICU: A Retrospective Cohort Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 57-57
Author(s):  
Thomas Bodley ◽  
Maverick Chan ◽  
Lauren Clarfield ◽  
Olga Levi ◽  
Avery Longmore ◽  
...  
Keyword(s):  
Blood Cell ◽  
Major Bleeding ◽  
Red Blood Cell ◽  
Sofa Score ◽  
Bleeding Event ◽  
Severity Of Illness ◽  
Red Blood Cell Transfusion ◽  
Bleeding Events ◽  
Major Bleeding Event ◽  
Major Bleeding Events

Introduction: Frequent blood testing in the intensive care unit (ICU) is instrumental to patient diagnosis, monitoring, and titration of invasive therapies. However, there is a growing appreciation that a significant proportion of ICU blood tests are reflexive and unnecessary.1,2 Serial phlebotomy is associated with extended hospital length of stay and acquired anemia in the general hospital population.3 Since patients in the ICU are prone to developing anemia,4,5 they are likely at increased risk of harm from serial phlebotomy. In response, multiple recent campaigns advocate for physician restraint in laboratory test ordering.6,7 However, relatively little is known about the effect of excessive phlebotomy on outcomes in critically ill patients. Better understanding of ICU phlebotomy practices, and harms associated with serial testing, is important in planning, implementing, and evaluating phlebotomy reduction interventions. Objectives: 1) Quantify average daily phlebotomy volume for ICU patients including blood discarded as waste when accessing vascular devices. 2) Identify if average daily phlebotomy volume is an independent risk factor for ICU acquired anemia (hemoglobin < 80 g/L) or the need for red blood cell transfusion. 3) Explore the relationship between daily phlebotomy volume and hospital mortality. Methods: This was a retrospective cohort study at an academic tertiary care center in Toronto, Ontario, utilizing hospital administrative data, laboratory data, and select chart review. Index Medical Surgical ICU admissions between September 2014 and August 2015 with an ICU stay of three days or greater were included. Major bleeding events were defined as a hemoglobin drop of 30 g/L within a 24 hour period. Average daily phlebotomy volumes were calculated using the number of samples received by the lab multiplied by standard blood volumes required for each sample type. A bedside prospective audit was conducted in March 2018 to quantify average blood volume discarded as waste during phlebotomy. Blood discard/waste data were summarized with descriptive statistics, but not included in further analysis. Multivariable logistic regression was used to study the association between average daily phlebotomy volume and each of: nadir hemoglobin (< 80 g/L), the need for red blood cell transfusion, and hospital mortality. Patients with a major bleeding event were excluded from the regression. Control variables included sex, age, ICU length of stay, admission hemoglobin, and admission Sequential Organ Failure Assessment (SOFA) score. Results: There were a total of 525 index patient admissions, mean age 62.1 yr, 41% female (Table 1). Fifty-two (52) patients had a major bleeding event in the ICU. Mean phlebotomy volume per patient day was 28.3 mL (95% CI 27.4 - 29.1 mL, stdev 10.1 mL). Mean bedside waste during the phlebotomy audit (total of 144 blood draws) varied by vascular access: 3.9 mL for arterial, 5.5 mL for central venous, and 6.25 mL for peripherally inserted catheters. The mean estimated daily bedside waste for phlebotomy was 14.8 mL per patient day. Outcomes of logistical regression, excluding patients with major bleeding events, are summarized in Table 2. Average daily phlebotomy volume (mL) was predictive of nadir hemoglobin < 80 g/L (parameter estimate 0.091, p <0.001), the need for red blood cell transfusion (0.092, p<0.001), and inpatient mortality (0.053, <0.001). For every 5 mL increase in average daily phlebotomy, the odds ratio (OR) for nadir hemoglobin < 80 g/L was 1.58 (95% CI 1.31 - 1.90) and the OR for a red cell transfusion was 1.58 (95% CI 1.33 - 1.87). Conclusion: Daily ICU phlebotomy volume is associated with ICU acquired anemia and the need for red blood cell transfusion, including in a multivariable model with patient demographics, major bleeding events, and severity of illness as estimated by day 1 SOFA score. However, the ICU admission SOFA score was only weakly predictive of mortality, and the unexpected association between average daily phlebotomy and mortality needs to be further explored. It is possible that in this data set day 1 SOFA score did not completely control for severity of illness. Our findings support the need for ongoing phlebotomy stewardship interventions in the ICU. We suggest ICU acquired anemia and the need for red blood cell transfusion are appropriate patient outcome measures to evaluate stewardship interventions. Disclosures No relevant conflicts of interest to declare.

Incidence of major bleeding events and outcome of patients of 80 and 90 years or older with ongoing anticoagulants: five-year survey in northwest Tuscany

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Conti ◽  
I.C Bogazzi ◽  
M Mazzucchelli ◽  
A Covelli ◽  
D Molesti ◽  
...  
Keyword(s):  
Mortality Rate ◽  
Blood Cell ◽  
Major Bleeding ◽  
Red Blood Cell ◽  
Catchment Area ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Event ◽  
Bleeding Events ◽  
Major Bleeding Events

Abstract Objective To search for rates of major bleeding events in patients (pts) with age ≥80 or ≥90 years (y.) with ongoing anticoagulants referred to hospital. Methods Patients complaining any bleeding events were submitted to propensity score matching for major bleeding and stratified according to age ≥80 or ≥90 y. and warfarin or direct oral anticoagulants (DOACs). Setting A General Hospital, northwest Tuscany, five-year survey, 385,650 visits; catchment area 197,722 inhabitants, of whom 18,373 on warfarin and 14,808 on DOACs. Out of DOACs, dabigatran and rivaroxaban were available in the catchment area since 5 y., apixaban 4 y. and edoxaban 3 y; 5,553 pts received rivaroxaban, 4,602 dabigatran, 3,147 apixaban and 1,506 edoxaban. Endpoint Primary endpoint was one-week death, and incidence of major bleeding. Results Out of 7,474 pts considered, 2504 (33.5%) pts were older than 80 y., of whom 518 (6.8%) were older than 90 y; they were enrolled in the study. Overall, 253 (10.1%) showed history of stroke/TIA, 578 (22.9%) atrial fibrillation, 277 (11.1%) cancer, 177 (7.0%) congestive heart failure, 33 (1.3%) pulmonary thromboembolism. Of these 7,474 pts 1,040 (41.5%) showed major bleeding: 621 (24.8%) were gastrointestinal of which 258 (10.3%) of the upper tract and 363 (14.5%) of the lower tract; 794 (31.7%) were brain haemorrhage; the remaining patients showed other bleeding. Overall, 435 (5.8%) pts needed reversal anticoagulation, 325 (4.4%) red blood cell pack, and 2879 (38.5%) admission. Eventually, 127 pts have been readmitted to the hospital for ischemic stroke and 499 for new bleeding event. CHA2D2VASc-score was 2.5±1.5 and Charlston Comorbidity Index was 3.4±2.3. Out of 2,504 patients older than 80 y., 367 (14,7%) received anticoagulants (including heparin) of which 134 (5.4%) received warfarin versus 63 (2.5%) DOACs (p<0.001); 24 dabigatran, 19 rivaroxaban, 17 apixaban, and 3 edoxaban. Overall 88 (3.5%) needed reversal anticoagulation, 128 pts (5.1%) red blood cell pack, and 825 (32.9%) pts admission. One-week mortality rate as follows: anticoagulants 35 (1.4%) versus DOACs 6 (0.2%), p<0.001; dabigatran 0, rivaroxaban 2, apixaban 2, edoxaban 2. Out of 518 patients older than 90 y., 98 (18.9%) received anticoagulants (including heparin) of whom 44 (8.5%) received warfarin; 11 (2.1%) DOACs (p<0.001); 4 dabigatran, 2 rivaroxaban, 4 apixaban, and 1 edoxaban. Overall 24 (4.6%) needed reversal anticoagulation, 50 (9.7%) red blood cell pack, and 203 (39.2%) admission. One-week mortality rate as follows: anticoagulants 10 (1.9%) versus DOACs 1 (0.2%), p<0.001; dabigatran 0, rivaroxaban 0, apixaban 1 (0.2%), edoxaban 0. Conclusion Patients of 80 y. and even 90 y. or older, with ongoing warfarin, showed higher percentage of major bleeding events and mortality rate versus DOACs. Within DOACs, edoxaban was more likely to show lower rate of major bleeding events, without differences in death rate. Funding Acknowledgement Type of funding source: None

The Effect of BMI and Gender on Bleeding Events when Rivaroxaban Is Administered for Thromboprophylaxis Following Total Hip and Total Knee Arthroplasty

2018 ◽  
Vol 45 (02) ◽  
pp. 180-186 ◽  
Author(s):  
Eugene Krauss ◽  
Nancy Dengler ◽  
Barry Simonson ◽  
Kathleen Altner ◽  
Madison Daly ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Total Joint Arthroplasty ◽  
Bleeding Event ◽  
Joint Arthroplasty ◽  
Morbidly Obese ◽  
Bleeding Events ◽  
Major Bleeding Event ◽  
Major Bleeding Events ◽  
And Gender

AbstractRivaroxaban is approved in Europe and the United States for thromboprophylaxis following total joint arthroplasty. As the rate of obesity increases, confirming safety and efficacy in this patient population is paramount. This retrospective chart review assessed the efficacy and safety of rivaroxaban between two body mass index (BMI) groups: normal or overweight (< 30 kg/m2) and obese or morbidly obese (≥30 kg/m2). Safety outcome was a major bleeding event, defined as a decrease in hemoglobin of at least 2 g/dL from postoperative day 1(POD 1) to discharge or a blood transfusion of at least two units. Efficacy outcome was venous thromboembolism within 35 days postoperatively. There were 68 (68/1,241; 5.48%) major bleeding events. There was no significant association between major bleeding events and BMI in the univariable analysis (p < 0.36). However, after adjusting for other factors in the multivariable model, there was a significant interaction between BMI and gender (p < 0.001). Among males, the incidence of major bleeding events was three times greater in obese/morbidly obese subjects as compared with normal/overweight male subjects (odds ratio [OR]: 3.09, 95% confidence interval [CI]: 1.25, 7.62). Among females, incidence of having a major bleeding event was almost two times greater in normal/overweight subjects as compared with obese/morbidly obese female subjects (OR: 2.17, 95% CI: 1.10, 4.35). Incidence of venous thromboembolism was 0.4% in each group. The authors' study results highlight a previously unexplored association between BMI and gender-dependent differences in bleeding outcomes when rivaroxaban is used for thromboprophylaxis following total joint arthroplasty.

P3758Clinical characteristics and outcomes of atrial fibrillation patients with thrombocytopenia: the Fushimi AF Registry

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Ishigami ◽  
Y Aono ◽  
S Ikeda ◽  
K Doi ◽  
Y An ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Platelet Count ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Bleeding Events ◽  
Major Bleeding Event ◽  
Entire Cohort ◽  
Severe Group ◽  
The Mean

Abstract Background Thrombocytopenia is sometimes found in routine blood tests and is reported as a risk factor of major bleeding events and incidence of all-cause death after percutaneous coronary intervention. However, the influence of thrombocytopenia on clinical outcomes in patients with atrial fibrillation (AF) remains unknown. Purpose We aimed to investigate relationship between baseline platelet count and clinical outcomes such as all-cause death, hospitalization for heart failure, and the major bleeding event in AF patients. Methods The Fushimi AF Registry was designed to enroll all of the AF patients in Fushimi-ku, Kyoto. Fushimi-ku is densely populated with a total population of 283,000 and is assumed to represent a typical urban community in Japan. Follow-up data with baseline platelet counts were available in 4,179 patients from March 2011 to November 2018. We divided the entire cohort into 3 groups according to baseline platelet level: No thrombocytopenia (≥150,000/μL, n=3,323), Mild thrombocytopenia (100,000–149,999/μL, n=707), and Moderate/severe thrombocytopenia (≤99,999/μL, n=149). Results In the entire cohort, the mean age was 73 years, 40% were women, and the mean body weight and body mass index was 59 kg and 23.1 kg/m2, and the median platelet count were 192,000/μL (interquartile range 156,000 to 232,000/μL), respectively. Compared to No thrombocytopenia, patients with thrombocytopenia were older (No vs. Mild vs. Moderate/severe; 73.3 years vs. 76.5 years vs. 75.8 years, p<0.0001), more likely to have heart failure (27.0% vs. 32.8% vs. 41.6%, p<0.0001), more likely to have chronic renal disease (35.7% vs. 42.6% vs. 57.7%, p<0.0001), and had higher CHADS2 score (2.05 vs. 2.17 vs. 2.34, p=0.0039) and CHA2DS2-VASc score (3.40 vs. 3.52 vs. 3.71, p=0.0416). Patients with thrombocytopenia had lower hemoglobin (13.0 vs. 12.8 vs. 11.6, p<0.0001) than No thrombocytopenia. However, prevalence of previous major bleeding events was comparable between three groups (4.66% vs. 4.67% vs. 5.37%, p=0.92) On Kaplan-Meier analysis, the incidence of all-cause death was higher in Mild group (hazard ratio [HR] 1.51; 95% confidence interval [CI] 1.28–1.77) and Moderate/severe group (HR 2.97; 95% CI 2.28–3.80) than No group (Figure 1). The incidence of hospitalization for heart failure was higher in Mild group (HR 1.62; 95% CI 1.31–1.99) and Moderate/severe group (HR 2.64; 95% CI 1.76–3.81) than No group (Figure 2). The incidence of major bleeding event was higher in Mild group (HR 1.46; 95% CI 1.11–1.91) and Moderate/severe group (HR 2.45; 95% CI 1.41–3.91) than No group (Figure 3). Conclusion Thrombocytopenia in AF patients was associated with higher incidence of all-cause death, hospitalization for heart failure, and major bleeding event in the Fushimi AF Registry. Acknowledgement/Funding Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, Bayer Healthcare,and Daiichi-Sankyo

Major Bleeding with Ibrutinib: More Than Expected

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3229-3229 ◽  
Author(s):  
Paul R Kunk ◽  
Joesph Mock ◽  
Michael E. Devitt ◽  
Surabhi Palkimas ◽  
Jeremy Sen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Major Bleeding ◽  
Research Funding ◽  
Bleeding Event ◽  
Lymphocytic Leukemia ◽  
Significant Activity ◽  
University Of Virginia ◽  
Bleeding Events ◽  
Major Bleeding Events

Abstract Introduction: Ibrutinib is a Bruton's tyrosine kinase inhibitor that has significant activity in treating lymphoma. While approved for patients with Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL), its activity in other lymphomas and solid tumors is under investigation and its use is increasing dramatically. Overall it is well tolerated compared to chemotherapy, but bleeding has emerged as a common adverse event with rates as high as 50% and major bleeding around 3% (Jones, abstract #1990, 2014 ASH Annual Meeting). As the use of ibrutinib increases outside of a clinical trial setting, the rate of major bleeding is likely to rise. Methods: To better understand the risk of bleeding in ibrutinib treated patients, we reviewed all patients at the University of Virginia and satellite clinics who were treated with ibrutinib between January 2012 and May 2016. Patients were required to be treated for at least 1 month with documented follow up for assessment of adverse events. Medical charts were reviewed for age, gender, ibrutinib indication and dose, length of treatment, concurrent medications, blood tests and bleeding events. All forms of anti-platelets and anticoagulants drugs, as well as medications interacting with cytochrome P450 3A4 (3A4), which metabolizes ibrutinib, were recorded. All bleeding events were recorded and graded according the Common Toxicity Criteria for Adverse Events, v4.0. Major bleeding events were reviewed by all investigators. Results: Eighty-nine patients were identified. Eighteen patients were excluded for insufficient follow up leaving 71 patients for analysis. Median age was 73 years old (44-92) with 74% male. The most common indications for treatment were CLL (65%) and MCL (27%). Most patients were treated with either 420mg (64%) or 560mg (21%). Median length of time on ibrutinib was 412 days, most with ongoing use at time of data collection. Seventy percent of patients were also treated with an anti-platelet medication, mostly aspirin for CAD with several patients on multiple anti-platelet medications. Seventeen percent were treated with an anti-coagulant, mostly apixaban for atrial fibrillation. Thirteen percent of patients (9/71) were treated with combined anti-platelet and anti-coagulant medications. Ten percent of patients were treated with a medication that has a moderate or strong interaction with 3A4. Bleeding of any grade occurred in 56% of patients, mostly bruising and epistaxis. Major bleeding, defined as grade 3 or higher, occurred in 18% of patients. Three patients developed major bleeding after an invasive procedure without ibrutinib being held. One patient died as a result of peri-procedural bleeding. Of the 9 patients treated with combined anti-platelet and anti-coagulant therapy, 78% suffered a major bleeding event. Of the ten patients on ibrutinib alone, without concurrent use of an anti-platelet, anti-coagulant or 3A4 drug interaction, no major bleeding events occurred. Conclusion: In this study examining real world use of ibrutinib, the rates of major bleeding are higher than previously reported. Most patients who suffered major bleeding were also treated with an anti-coagulant and/or anti-platelet medication. As the use of ibrutinib increases outside of clinical trials, a careful review of medications should be performed in addition to adherence to perioperative drug withholding guidelines. Patients requiring anti-coagulant and/or anti-platelet medications while on ibrutinib need careful consideration of the risks and benefits given the higher incidence of bleeding in this population. Table 1 Table 1. Disclosures Portell: AbbVie: Research Funding; Roche/Genentech: Research Funding; Infinity: Research Funding; Acerta: Research Funding. Williams:Janssen and Pharmacyclics: Research Funding; University of Virginia: Employment.

Major Bleeding Complications Among Patients Treated with Ibrutinib and Concomitant Antiplatelet, Anticoagulant, or Supplemental Therapy

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4387-4387 ◽  
Author(s):  
Aaron Pavlik ◽  
Hallie Barr ◽  
Emily Dotson ◽  
John C. Byrd ◽  
Kristie A. Blum ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Board Of Directors ◽  
Major Bleeding ◽  
Research Funding ◽  
Bleeding Event ◽  
Antiplatelet Agents ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Advisory Committees ◽  
Major Bleeding Events

Abstract Background: Ibrutinib, an orally bioavailable small molecular inhibitor of Bruton's tyrosine kinase (BTK), is an approved therapy for chronic lymphocytic leukemia (CLL), relapsed mantle cell lymphoma (MCL) and Waldenstrӧm's macroglobulinemia (WM). Beyond B lymphocytes, BTK signaling is important for collagen-mediated platelet activation, and BTK inhibition has been associated with primary hemostatic bleeding events (Levade et al Blood 2014). Although serious bleeding events have been uncommon (1-5%) in clinical trial populations, there is limited data describing the potential for increased serious bleeding incidence when ibrutinib is co-administered with other agents affecting the clotting cascade or platelet function. Methods: We conducted a retrospective cohort study to evaluate the incidence of major bleeding in patients receiving ibrutinib concomitantly with antiplatelet agents (non-steroidal anti-inflammatory agents, ADP inhibitors), anticoagulants (heparins, warfarin, novel oral anticoagulants), or supplements with potential anticoagulant activity (vitamin E and fish oil). Major bleeding events were identified using criteria developed by the International Society on Thrombosis and Haemostasis (Schulman et al J Thromb Haemost 2005). Patients 18-89 years of age and treated with ibrutinib for CLL, MCL, or WM between March 1, 2010 and March 1, 2015 were included. The primary endpoint of this study was the incidence of major bleeding events, but we also sought to identify risk factors associated with the development of major bleeding, focusing on potential drug interactions. Based on the historic prevalence of major bleeding in ibrutinib clinical studies, we calculated that at least 20 major bleeding events would need to be identified in order to perform blinded multinomial regression on the collected data of an estimated 400 patients. Results: 437 eligible patients were included in the analysis. Patients were overwhelmingly male (71.4%) and white (94.8%), with a mean age of 67.1 years (range: 29-89). 53.1% received ibrutinib as participants of a clinical trial, and the remainder received standard-of-care ibrutinib treatment. The table (upper panel) summarizes use of concomitant antihemostatic agents by presence or absence of major bleeding events. Characteristics of the major bleeding events are further detailed in the lower panel. The most commonly observed concomitant antihemostatic medication was aspirin, with 147 patients (33.6%) being exposed to aspirin within the study period. Fourteen instances of major bleeding were observed, corresponding to an overall incidence of 3.2%. These major bleeding events all occurred in CLL patients receiving ibrutinib at the standard dose of 420 mg daily. Two patients had platelet counts less than 50 k/µL at time of the bleeding event. One-half of the major bleeding events were observed in the absence of an antihemostatic medication, and 2 of the observed major bleeding events resulted in death (1 received concomitant warfarin). Fourteen patients (3.3%) in the group without major bleeding were on anticoagulation, 4 being warfarin. The most common sites of major bleeding were gastrointestinal (50%), intracranial (14.3%) and thoracic (14.3%). While most patients developing major bleeding permanently discontinued ibrutinib (57.1%), approximately one third of the patients who developed major bleeding subsequently resumed ibrutinib following resolution of the bleeding event. Subsequently, these patients did not experience a recurrent major bleeding event. The rate of major bleeding did not meet power to detect statistical differences in bleeding events when comparing concomitant therapy, Conclusions: Our observed incidence of major bleeding is consistent with previous controlled clinical trials, suggesting similar safety profile when ibrutinib is used outside of a controlled setting. Major bleeding events were uncommon despite the frequent co-administration of antiplatelet agents. However, because we modified practice early to avoid therapeutic anticoagulation during ibrutinib therapy whenever possible, the number of patients receiving such drugs in combination was small and precludes inferences regarding safety. Table Table. Disclosures Blum: Pharmacyclics: Research Funding. Awan:Innate Pharma: Research Funding; Pharmacyclics: Consultancy; Novartis Oncology: Consultancy. Woyach:Acerta: Research Funding; Karyopharm: Research Funding; Morphosys: Research Funding. Christian:Pharmacyclics: Research Funding; Janssen: Research Funding. Jones:Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Membership on an entity's Board of Directors or advisory committees, Research Funding; Pharmacyclics, LLC, an AbbVie Company: Membership on an entity's Board of Directors or advisory committees, Research Funding.

Abstract 12014: Modified HASBLED Bleeding Risk Score in Dialysis Patients With Atrial Fibrillation

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Michele Murphy ◽  
William Maddox ◽  
Stan Nahman ◽  
Matthew Diamond ◽  
Robert Sorrentino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Failure ◽  
Liver Function ◽  
Renal Disease ◽  
Risk Score ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Bleeding Events ◽  
Major Bleeding Events

Introduction: Hemodialysis patients (HD pts) with atrial fibrillation (AF) have increased risk of stroke. The HASBLED (Hypertension (HTN), Abnl Renal/Liver Function, Stroke, Bleeding Hx, Labile INR, Elderly, Drugs/Alcohol) risk score predicts bleeding in the general AF population. It is unknown whether the HASBLED score can be applied to HD pts who are at additional bleeding risk due to uremic platelet dysfunction and the regular use of heparin. Hypothesis: To address this question, we queried the United States Renal Data System (USRDS) for bleeding events in HD pts with AF, and correlated those events with a modified HASBLED (mHASBLED) score. Methods: All incident HD pts with AF from the USRDS for 2006-2010 were queried for major bleeding events and mHASBLED parameters using ICD-9 diagnosis codes and data from CMS form 2728. For mHASBLED, the HTN parameter was defined as "HTN as the cause of renal failure", and labile INR as > 16 INRs/yr, but all other parameters could be derived from the dataset. Logistic regression (LR) analysis was used to estimate the odds ratio (OR) for the mHASBLED score to predict major bleeding events. Results: 74,631 HD pts had AF, and 9.8% had a major bleeding event (GI bleeding and hemorrhagic stroke). By univariate analysis, those who bled were more likely to be elderly, have an underlying cause of renal disease due to HTN, prior bleeding event, hepatitis C, labile INR, and be on oral anticoagulants. By LR, variables with the greatest impact on bleeding were HTN as a cause of underlying renal disease, prior bleeding history, and labile INR (OR of 1.10, 2.20 and 2.24, respectively). The OR for bleeding events increased by 1.28 for each unit increase in mHASBLED. Older age, prior stroke, abnormal renal or liver function, and drug use had the least effect. Note that the lowest possible score in this cohort is 1, given that all patients had renal failure. Conclusions: In HD pts with AF, the mHASBLED predicts major bleeding events. The universal presence of renal disease, and the lack of specific clinical data from the USRDS may limit the clinical precision of a given score, however mHASBLED may remain a useful indicator of bleeding risk in this population.

Novel bleeding prediction model in atrial fibrillation patients on new oral anticoagulants

Heart ◽  
2021 ◽  
pp. heartjnl-2021-319702
Author(s):  
Ofra Barnett-Griness ◽  
Nili Stein ◽  
Antonio Kotler ◽  
Walid Saliba ◽  
Naomi Gronich
Keyword(s):  
Atrial Fibrillation ◽  
Health Services ◽  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Bleeding Event ◽  
New Oral Anticoagulants ◽  
Selection Algorithm ◽  
Bleeding Events ◽  
Major Bleeding Events

ObjectiveClinical models such as the HAS-BLED (standing for Hypertension, Abnormal liver/renal function, Stroke history, Bleeding history or predisposition, Labile INR, Elderly, Drug/alcohol usage) were developed to predict risk of major bleeding on vitamin K antagonists/antiplatelet therapy. We aimed to develop a model that will improve the ability to predict major bleeding events in patients with non-valvular atrial fibrillation (AF) treated with new oral anticoagulants (NOACs).MethodsClalit Health Services is the largest of four integrated healthcare organisations in Israel, which insures 4.7 million patients (53% of the population). We identified in Clalit Health Services all patients with AF, new users of an NOAC (2013–2017), and followed them until first occurrence of a major bleeding event, death, switch to another oral anticoagulant, 30 days after discontinuation of NOAC or end of follow-up (31 December 2019). Importance of the candidate model variables was estimated by inclusion frequencies across forward selection algorithm applied to 50 bootstrap samples. Then, backward selection algorithm using the modified Bayesian Information Criterion for competing risks was applied to select predictors for the final model.Results47 623 patients with AF prescribed NOAC were studied. 28 055 patients with AF, initiators of apixaban (mean age 78.7, SD 9.0), were included in the first phase and had 662 major bleeding events. Nine variables were selected for inclusion in a final points-based risk-scoring system: male sex, anaemia, thrombocytopaenia (<99×103/µL), concurrent antiplatelet therapy, hypertension, prior major bleeding, risk factors for a fall, low cholesterol level and low estimated glomerular filtration rate, with apparent area-under-curve (AUC) of 0.6546. Applicability of the model was then shown for 14 118 and 5450 patients with AF, initiators of dabigatran and rivaroxaban, where the score achieved c indices of 0.62 and 0.61, respectively.ConclusionsWe present a novel and simple risk score for prediction of major bleeding in patients with non-valvular AF treated with NOACs. Validation in additional cohorts is warranted.

Randomized, Parallel Group, Multicenter, Multinational Study Evaluating Safety of DU-176b Compared with Warfarin in Subjects with Non-Valvular Atrial Fibrillation

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 33-33 ◽  
Author(s):  
Jeffrey I. Weitz ◽  
Stuart J. Connolly ◽  
Satoshi Kunitada ◽  
James Jin ◽  
Indravadan Patel
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Phase Iii ◽  
Fixed Dose ◽  
Bleeding Events ◽  
Treatment Groups ◽  
Parallel Group ◽  
Elevated Liver Enzymes ◽  
Major Bleeding Events

Abstract Introduction : The primary objective of this phase II study was to assess the safety of different dose regimens of DU-176b, an oral direct factor Xa inhibitor, in patients with non-valvular atrial fibrillation (AF). Methods : This was a randomized, parallel group, multicenter, multinational, double-blind DU-176b and open-label warfarin safety study in patients with AF (CHADS2 index ≥ 2). Patients were randomly assigned to receive either one of four fixed dose regimens of DU-176b (30 mg qd, 30 mg bid, 60 mg qd or 60 mg bid) or warfarin dose-adjusted to a target international normalized ratio (INR) of 2.0–3.0. for 12 weeks. Investigators, sponsor and study subjects were blinded to DU-176b dose but not to the identity of DU-176b vs. warfarin. Investigators adjusted warfarin doses based on INR values obtained in local laboratories. The INR was determined weekly for 4 weeks and every two weeks thereafter. The primary outcomes were the occurrence of centrally adjudicated major and/or clinically relevant non-major bleeding event, and elevated liver enzymes and/or bilirubin. Secondary outcomes included major adverse cardiovascular events (MACE), a composite of stroke, systemic embolism, acute myocardial infarction, hospitalizations due to cardiovascular condition or cardiovascular death, as well as all other adverse events, including all bleeding events. Results : A total of 1,146 patients were randomized. There were no clinically relevant differences between treatment groups with respect to the demographic data and baseline characteristics. Mean age was 65±8.7 years, 63.3% of patients had a CHADS2 index of 2 and 64.40% were warfarin naïve. The DU-176b 60 mg bid treatment arm was prematurely terminated during the study based on a recommendation by the Independent Data Monitoring Committee (DMC). A total of 180 patients were randomized to this group at the time. The incidence of major and clinically relevant non-major bleeding events was significantly higher in both the DU-176b 60 mg bid and 30 mg bid groups than in those given warfarin. The incidence of major and clinically relevant non-major bleeding events in the DU-176b 30 mg qd and 60 mg qd groups was similar to that in warfarin-treated patients. The time in therapeutic range (TTR) for warfarin-experienced patients was 50.1% and for warfarin naïve patients was 41.8%. There were no significant differences in the number (%) of subjects with persistently elevated ALT, AST, or bilirubin values across the treatment groups. The incidence of stroke was similar across treatment groups (Table). DU-176b 30 mg qd N=235 DU-176b 60 mg qd N=234 DU-176b 30 mg bid N=244 DU-176b 60 mg bid N=180 Warfarin qd N=250 Bleeding, n (%) (95% CI) Major+CR non-major 7 (3.0) (1.2–6.0) 11 (4.7) (2.4–8.3) 19 (7.8) (4.8–11.9)a 19 (10.6) (6.5–16.0)b 8 (3.2) (1.4–6.2) Major 0 (0) (0–1.6) 1 (0.4) (0–2.4) 5 (2.0) (0.7–4.7) 6 (3.3) (1.2–7.1)a 1 (0.4) (0–2.2) All 13 (5.5) (3.0–9.3) 19 (8.1) (5.0–12.4) 32 (13.1) (9.1–18.0) 33 (18.3) (13.0–24.8)b 20 (8.0) (5.0–12.1) Stroke, n (%) (95% CI) 1 (0.4) (0–2.3) 1 (0.4) (0–2.4) 2 (0.8) (0.1–2.9) 2 (1.1) (0.1–4.0) 4 (1.6) (0.4–4.0) Conclusions : DU-176b 30 mg qd and 60 mg qd dose regimens had a safety profile similar to warfarin in patients with AF. Patients treated with the DU-176b 30 mg bid or 60 mg bid regimens had more bleeding events than occurred with warfarin. These results suggest that the DU-176b 30 mg qd or 60 mg qd regimens are safe and well tolerated. A Phase III trial is needed to determine whether DU-176b will provide a suitable replacement for warfarin in AF patients. CR, clinically relevant. aP&lt;0.05, bP=0.002 to warfarin.

scholarly journals LO94: Evaluation of stroke and bleeding outcomes among patients managed in the emergency department for newly diagnosed atrial fibrillation

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S41-S42
Author(s):  
S. Niaz ◽  
C. Kirwan ◽  
N. Clayton ◽  
M. Mercuri ◽  
K. de Wit
Keyword(s):  
Atrial Fibrillation ◽  
Emergency Department ◽  
Major Bleeding ◽  
Bleeding Event ◽  
National Guidelines ◽  
Bleeding Events ◽  
Chads2 Score ◽  
Major Bleeding Event ◽  
Ischemic Attack ◽  
New Diagnosis

Introduction: Atrial Fibrillation (AF) is the most common arrhythmia seen in patients presenting to the emergency department (ED). AF increases the risk of ischemic stroke which can be mitigated by anticoagulant prescription. National guidelines advise that emergency physicians initiate anticoagulation when AF is first diagnosed. We aimed to evaluate the 90-day incidence of stroke and major bleeding among emergency patients discharged home with a new diagnosis of AF. Methods: This was a health records review of patients diagnosed with AF in two EDs. We included patients ≥ age 18, with a new diagnosis of AF who were discharged from the ED, between 1st May 2014 and 1st May 2017. Using a structure review we collected data on CHADS65 and CHADS2 scores, contraindications to direct oral anticoagulant (DOAC) prescription and initiation of anticoagulation in the ED. Patient charts were reviewed for the diagnosis of stroke, transient ischemic attack (TIA), ischemic gut, ischemic limb or other systemic embolism within 90 days of the index ED presentation. We extracted data on major bleeding events within 90 days, defined by the International Society of Thrombosis and Haemostasis criteria. All data were extracted in duplicate for validation. Results: We identified 399 patients fulfilling the inclusion criteria, median age 68 (IQR 57-79), 213 (53%) male. 11 patients were already prescribed an anticoagulant for another indication and 19 had a contraindication to prescription of a DOAC. 48/299 (16%) CHADS65 positive patients were initiated on an anticoagulant, 3 of whom had a contra-indication to initiation of anticoagulation in the ED (1 dual antiplatelet therapy, 2 liver cirrhosis). 1/100 CHADS65 negative patients was initiated on anticoagulation. The median CHADS2 score was 1 (IQR 0-2). Among the 49 patients initiated on anticoagulation, 3 patients had a stroke/TIA within 90 days, 6.1% (95% CI; 2.1-16.5%). There were no bleeding events 0.0% (95% CI; 0.0-7.3%). Among the 350 patients who were not initiated on anticoagulation in the ED, 4 patients had a stroke/TIA 1.1% (95% CI; 1.1-2.9%) within 90 days and 2 patients had a major bleeding event. Conclusion: Prescription of anticoagulation for new diagnoses of AF was under-utilized in these EDs. The 90-day stroke/TIA rate was high, even among those given an anticoagulant prescription in the ED. No patient had an anticoagulant-associated bleeding event.

scholarly journals Major Bleeding Events and Associated Factors in a Cohort of Adult Patients Taking Warfarin in an Armed Forces Hospital

2020 ◽  
Vol 5 (4) ◽  
Author(s):  
Manvikram Singh Gill
Keyword(s):  
Sample Size ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Demographic Data ◽  
Direct Oral Anticoagulants ◽  
Bleeding Event ◽  
Armed Forces ◽  
Bleeding Events ◽  
Medication Therapy ◽  
Major Bleeding Events

Introduction: Warfarin is widely utilized in patients with Atrial Fibrillation (AF) in Malaysia. However, risk of haemorrhage which necessitates monitoring of International Normalised Ratio (INR) and extensive interaction which varies across ethnicity supports the use of Direct Oral Anticoagulants (DOACS). This study is to assess whether demographic data, medical history, and medication history are associated with the risk of major bleeding events. Methodology: Data was collected retrospectively in a case-controlled environment from the Electronic Medical Record (EMR) database. These patients were attending Medical Out-patient Department (MOPD) clinic, Tuanku Mizan Armed Forces Hospital (TMAFH) from 2nd to 31st January 2018. Results: Among 60 AF patients reviewed, 83% had labile INR range and 35% reported to have 1 or more bleeding event. It is found there is significant association (p<0.05) for variables of sex, history of stroke, and NSAID usage with the outcome. Discussion: Majority of patients with major bleeding events are Chinese males. The sample size of the current study is too small to be able to arrive at any conclusive results. Conclusion: Further studies with bigger sample size are needed among Malaysian Chinese male population. MOPD should establish a warfarin Medication Therapy Adherence Clinic (MTAC) to optimise pharmaceutical care.

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