scholarly journals Development of a Multicomponent Implementation Strategy to Reduce Upper Gastrointestinal Bleeding Risk in Patients Using Warfarin and Antiplatelet Therapy, and Protocol for a Pragmatic Multilevel Randomized Factorial Pilot Implementation Trial

2021 ◽  
Author(s):  
Jacob Kurlander ◽  
Danielle Helminski ◽  
Michael Lanham ◽  
Jennifer L Henstock ◽  
Kelley M Kidwell ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Implementation Strategy ◽  
Controlled Trial ◽  
Bleeding Risk ◽  
Primary Objective ◽  
Gi Bleeding ◽  
Optimization Strategy ◽  
To Receive ◽  
Upper Gastrointestinal ◽  
Implementation Trial

Abstract BackgroundConcomitant use of anticoagulant and antiplatelet medications increases the risk of upper gastrointestinal (GI) bleeding. Two underused evidence-based practices (EBPs) can reduce the risk: de-prescribe unnecessary antiplatelet therapy or initiate a proton pump inhibitor. We describe 1) the development of a multicomponent intervention to increase use of these EBPs in patients treated with warfarin and followed by an anticoagulation monitoring service (AMS) and 2) the design of a pilot pragmatic implementation trial.MethodsA participatory planning group iteratively used Implementation Mapping and the Multiphase Optimization Strategy to develop implementation strategies and plan the trial. Informed by qualitative interviews with patients and clinicians, we drew on several implementation science theories, as well as self-determination theory, to design interventions. For patients, we developed an activation guide to help patients discuss the EBPs with their clinicians. For clinicians, we developed two electronic health record (EHR)-based interventions: (1) Clinician notification (CN) consists of a templated message that identifies a patient as high risk, summarizes the EBPs, and links to a guidance statement on appropriate use of antiplatelet therapy. (2) Clinician notification with nurse facilitation (CN+NF) consists of a similar notification message but includes additional measures by nursing staff to support appropriate and timely decision-making: The nurse performs a chart review to identify any history of vascular disease, embeds indication-specific guidance on antiplatelet therapy in the message, and offers to assist with medication order entry and patient education. We will conduct a pilot factorial cluster- and individual-level randomized controlled trial with a primary objective of evaluating feasibility. Twelve clinicians will be randomized to receive either CN or CN+NF for all their patients managed by the AMS while 50 patients will be individually randomized to receive either the activation guide or usual care. We will explore implementation outcomes using patient and clinician interviews along with EHR review.DiscussionThis pilot study will prepare us to conduct a larger optimization study to identify the most potent and resource conscious multicomponent implementation strategy to help AMSs increase use of best practices for upper GI bleeding risk reduction.Trial RegistrationClinicalTrials.gov, NCT05085405, Registered 19 October 2021 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT05085405

scholarly journals Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial

Gut ◽  
2020 ◽  
pp. gutjnl-2020-321585 ◽  
Author(s):  
Suzanne E Mahady ◽  
Karen L Margolis ◽  
Andrew Chan ◽  
Galina Polekhina ◽  
Robyn L Woods ◽  
...  
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Bleeding Risk ◽  
The Elderly ◽  
Community Dwelling ◽  
Gi Bleeding ◽  
Prophylactic Use ◽  
Randomised Controlled

ObjectiveThere is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.DesignData were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010–2017 (‘ASPirin in Reducing Events in the Elderly (ASPREE)’, n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.ResultsOver a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.ConclusionAspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.Trial registration numberASPREE. NCT01038583.

T1963 High-Risk Patients for GI Bleeding On Dual Antiplatelet Therapy in Spain Are More Like to Receive PPI Therapy Than Their American Peers

2009 ◽  
Vol 136 (5) ◽  
pp. A-610
Author(s):  
Angel Lanas ◽  
Liz Guastello ◽  
Ruben Casado ◽  
Sameer D. Saini ◽  
Monica Polo-Tomas ◽  
...  
Keyword(s):  
High Risk ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Gi Bleeding ◽  
High Risk Patients ◽  
Risk Patients ◽  
To Receive

scholarly journals Bupivacaine Lozenge Compared with Lidocaine Spray as Topical Pharyngeal Anesthetic before Unsedated Upper Gastrointestinal Endoscopy: A Randomized, Controlled Trial

2014 ◽  
Vol 7 ◽  
pp. CGast.S18019 ◽  
Author(s):  
Nesrin Salale ◽  
Charlotte Treldal ◽  
Stine Mogensen ◽  
Mette Rasmussen ◽  
Janne Petersen ◽  
...  
Keyword(s):  
Gastrointestinal Endoscopy ◽  
Controlled Trial ◽  
Primary Objective ◽  
Upper Gastrointestinal Endoscopy ◽  
Patient Discomfort ◽  
Significant Difference ◽  
Group A ◽  
Gag Reflex ◽  
Lidocaine Spray ◽  
Upper Gastrointestinal

Unsedated upper gastrointestinal endoscopy (UGE) can induce patient discomfort, mainly due to a strong gag reflex. The aim was to assess the effect of a bupivacaine lozenge as topical pharyngeal anesthetic compared with standard treatment with a lidocaine spray before UGE. Ninety-nine adult outpatients undergoing unsedated diagnostic UGE were randomized to receive either a bupivacaine lozenge (L-group, n = 51) or lidocaine spray (S-group, n = 42). Primary objective was assessment of patient discomfort including acceptance of the gag reflex during UGE. The L-group assessed the discomfort significantly lower on a visual analog scale compared with the S-group ( P = 0.02). There was also a significant difference in the four-point scale assessment of the gag reflex ( P = 0.03). It was evaluated as acceptable by 49% in the L-group compared with 31% in the S-group. A bupivacaine lozenge compared with a lidocaine spray proved to be a superior option as topical pharyngeal anesthetic before an UGE.

scholarly journals Hydralazine versus Labetalol for acute control of blood pressure in patients with severe pre-eclampsia: a randomized controlled trial

2019 ◽  
Vol 8 (4) ◽  
pp. 1626
Author(s):  
Nayanika Gaur ◽  
Priyanka Kathuria
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Statistical Tests ◽  
Controlled Trial ◽  
Primary Objective ◽  
Target Blood Pressure ◽  
Double Blind ◽  
Randomized Controlled ◽  
To Receive ◽  
Sustained Increase

Background: Authors sought to compare the effectively of intravenous hydralazine and intravenous labetalol in controlling acute rise in blood pressure in patients with severe preeclampsia.Methods: In this double-blind randomized controlled trial, all pregnant women with sustained increase in blood pressure (BP) of 160 mmHg systolic or 110 mmHg diastolic or higher were randomized to receive intravenous (IV) hydralazine 5 mg (max. 4 doses) or IV labetalol in escalating doses of 20mg, 40mg, 80mg, 80mg to achieve target blood pressure of 150 mmHg systolic and 100 mmHg diastolic or lower. The primary objective of the study was to assess the time taken to control blood pressure. Secondary agendas were the number of repeat doses required and other side effect profile.Results: In the study duration of September 2015 to September 2017, authors enrolled 60 participants for our trial. The median time taken to achieve the target blood pressure was 22.4 minutes in both the groups. Close to half of the participants did not require repeat doses (46.66% with labetalol and 50% with hydralazine). No serious maternal or foetal side effects were noted during the study. Statistical tests were performed using SPSS for Windows version 22.Conclusions: As operated in the study, the efficacy of hydralazine and labetalol to control the acute rise in blood pressure is similar.

scholarly journals Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial

Circulation ◽  
2021 ◽  
Author(s):  
Pieter C. Smits ◽  
Enrico Frigoli ◽  
Jan Tijssen ◽  
Peter Jüni ◽  
Pascal Vranckx ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Antiplatelet Therapy ◽  
Controlled Trial ◽  
Oral Anticoagulant Therapy ◽  
Bleeding Risk ◽  
Coronary Stenting ◽  
Bleeding Events ◽  
Open Label ◽  
Clinical Trial Registration ◽  
High Bleeding Risk

Background: The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear. Methods: In the investigator-initiated, randomized, open-label MASTER DAPT trial, 4579 patients at high bleeding risk were randomized after 1-month dual APT (DAPT) to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication. In this subgroup analysis we report outcomes of populations with or without an OAC indication. In the population with an indication, patients changed immediately to single APT (SAPT) for 5 months (abbreviated regimen) or continued ≥ 2 months DAPT and SAPT thereafter (nonabbreviated regimen). Patients without an OAC indication changed to SAPT for 11 months (abbreviated regimen) or continued ≥5 months of DAPT and SAPT thereafter (nonabbreviated regimen). Coprimary outcomes at 335 days after randomization were: net adverse clinical outcomes (NACE; composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium [BARC] 3 or 5 bleeding events); major adverse cardiac and cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and type 2, 3, or 5 BARC bleeding. Results: NACE or MACE did not differ with abbreviated versus nonabbreviated APT regimens in patients with OAC indication (n=1666; HR, 0.83; 95% CI, 0.60 to 1.15, HR, 0.88; 95% CI, 0.60 to 1.30; respectively) or without OAC indication (n=2913; HR, 1.01; 95% CI, 0.77 to 1.33; HR, 1.06; 95% CI, 0.79 to 1.44; P interaction =0.35 and 0.45, respectively). BARC 2, 3 or 5 bleeding did not significantly differ in patients with OAC indication (HR, 0.83; 95% CI, 0.62 to 1.12) but was lower with abbreviated APT in patients without OAC indication (HR, 0.55; 95% CI, 0.41 to 0.74; P interaction =0.057). The difference in bleeding in patients without OAC indication was driven mainly by a reduction in BARC 2 bleedings (HR, 0.48; 95% CI 0.33 to 0.69; P interaction =0.021). Conclusions: Rates of NACE and MACCE did not differ with abbreviated APT in high bleeding risk patients with or without an OAC indication and resulted in lower bleeding rates in patients without an OAC indication. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique identifier:NCT03023020

scholarly journals Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; protocol for a randomised, placebo-controlled prophylaxis study (COPCOV)

2020 ◽  
Vol 5 ◽  
pp. 241
Author(s):  
William Schilling ◽  
James J. Callery ◽  
Walter Taylor ◽  
Mavuto Mukaka ◽  
Maneerat Ekkapongpisit ◽  
...  
Keyword(s):  
Global Economy ◽  
Healthcare Workers ◽  
Respiratory Infections ◽  
Controlled Trial ◽  
Healthcare Setting ◽  
Primary Objective ◽  
Infection Rates ◽  
Double Blind ◽  
Healthcare Facilities ◽  
To Receive

There is no proven preventative therapy or vaccine against COVID-19. Theinfection has spread rapidly and there has already been a substantial adverse impact on the global economy. Healthcare workers have been affected disproportionately in the continuing pandemic. Significant infection rates in this critical group have resulted in a breakdown of health services in some countries. Chloroquine, and the closely related hydroxychloroquine, are safe and well tolerated medications which can be given for years without adverse effects. Chloroquine and hydroxychloroquine have significant antiviral activity against SARS-CoV-2, and despite the lack of benefit of hydroxychloroquine treatment in patients hospitalised with severe COVID-19, these drugs could still work in prevention. The emerging infection paradigm of an early viral peak, and late inflammation where there is benefit from corticosteroids. If these direct actiing antivirals are to work, they have the best chance given either early in infection and before infection occurs. We describe the study protocol for a multi-centre, multi-country randomised, double blind, placebo controlled trial to answer the question- can chloroquine/ hydroxychloroquine prevent COVID-19. 40,000 participants working in healthcare facilities or involved in the management of COVID-19 will be randomised 1:1 to receive chloroquine/ hydroxychloroquine or matched placebo as daily prophylaxis for three months. The primary objective is the prevention of symptomatic, virological or serologically proven coronavirus disease (COVID-19). The study could detect a 23% reduction from an incidence of 3% in the placebo group for either drug with 80% power. Secondary objectives are to determine if chloroquine/hydroxychloroquine prophylaxis attenuates severity, prevents asymptomaticCOVID-19 and symptomatic acute respiratory infections of another aetiology (non-SARS-CoV-2).

scholarly journals One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients

2020 ◽  
Vol 13 (11) ◽  
Author(s):  
David E. Kandzari ◽  
Ajay J. Kirtane ◽  
Stephan Windecker ◽  
Azeem Latib ◽  
Elvin Kedhi ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Antiplatelet Therapy ◽  
Controlled Trial ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Drug Eluting Stents ◽  
Randomized Controlled ◽  
Percutaneous Coronary ◽  
Drug Eluting ◽  
High Bleeding Risk

Background: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients. Methods: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention. Results: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% ( P <0.001). Conclusions: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier NCT03647475.

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