EDUC'AVK: reduction of oral anticoagulant-related adverse events after patient education: a prospective multicenter open randomized study.
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ABSTRACT:
SUBMITTER: Pernod G
PROVIDER: S-EPMC2518037 | biostudies-other | 2008 Sep
REPOSITORIES: biostudies-other
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Project description:Introduction There is scarce real-world experience regarding direct oral anticoagulants (DOACs) perioperative management. No study before has linked bridging therapy or DOAC-free time (pre-plus postoperative time without DOAC) with outcome. The aim of this study was to investigate real-world management and outcomes. Methods RA-ACOD is a prospective, observational, multicenter registry of adult patients on DOAC treatment requiring surgery. Primary outcomes were thrombotic and hemorrhagic complications. Follow-up was immediate postoperative (24-48 hours) and 30 days. Statistics were performed using a univariate and multivariate analysis. Data are presented as odds ratios (ORs [95% confidence interval]). Results From 26 Spanish hospitals, 901 patients were analyzed (53.5% major surgeries): 322 on apixaban, 304 on rivaroxaban, 267 on dabigatran, 8 on edoxaban. Fourteen (1.6%) patients suffered a thrombotic event, related to preoperative DOAC withdrawal (OR: 1.57 [1.03-2.4]) and DOAC-free time longer than 6 days (OR: 5.42 [1.18-26]). Minor bleeding events were described in 76 (8.4%) patients, with higher incidence for dabigatran (12.7%) versus other DOACs (6.6%). Major bleeding events occurred in 17 (1.9%) patients. Bridging therapy was used in 315 (35%) patients. It was associated with minor (OR: 2.57 [1.3-5.07]) and major (OR: 4.2 [1.4-12.3]) bleeding events, without decreasing thrombotic events. Conclusion This study offers real-world data on perioperative DOAC management and outcomes in a large prospective sample size to date with a high percentage of major surgery. Short-term preprocedural DOAC interruption depending on the drug, hemorrhagic risk, and renal function, without bridging therapy and a reduced DOAC-free time, seems the safest practice.
| S-EPMC7319799 | biostudies-literature
Project description:ObjectivesThis study aimed to evaluate the efficacy and safety of apixaban replacement (AR) as an alternative to heparin bridging (HB) in patients taking warfarin and scheduled for endoscopic mucosal resection (EMR) in the colorectum.MethodsThis trial was conducted at seven institutes in Japan between May 2016 and May 2018. Enrolled patients had been taking oral warfarin and were diagnosed within 3 months with colorectal polyps for which EMR was indicated. Patients were randomly assigned to receive HB or AR. The primary endpoint was the incidence of postoperative bleeding. Secondary endpoints were the length of hospital stay, therapeutic endoscopy outcomes, and adverse events.ResultsThe planned sample size was 160 patients, but due to a decrease in the number of patients taking warfarin, the target number of cases could not be achieved within the case enrollment period, 44 cases were enrolled. They were divided into HB and AR groups. The incidence of postoperative bleeding was 15% (3/20) in HB and 0% in AR (P = 0.199). The total number of postoperative bleeding events was five in HB and none in AR. The length of hospital stay was significantly shorter in AR than in HB (median: 3.0 vs. 13.5 days, p < 0.001). There were no serious adverse events and no cerebral infarction/systemic embolism events.ConclusionAR for colorectal EMR may prove safe and has the potential to shorten hospital stay and reduce medical costs, though we were unable to evaluate the primary endpoint due to insufficient sample size.
| S-EPMC9302298 | biostudies-literature
Project description:INTRODUCTION:Oral anticoagulants (OACs) are widely prescribed in older adults. High OAC-related adverse event rates in the early period following hospital discharge argue for an analysis to identify predictors. Our objective is to identify and validate clinical and continuity of care variables among seniors discharged from hospital on an OAC, which are independently associated with OAC-related adverse events within 30 days. METHODS AND ANALYSIS:We propose a population-based retrospective cohort study of all adults aged 66 years or older who were discharged from hospital on an OAC from September 2010 to March 2015 in Ontario, Canada. The primary outcome is a composite of the first hospitalisation or emergency department visit for a haemorrhage or thromboembolic event or mortality within 30 days of hospital discharge. A Cox proportional hazards model will be used to determine the association between the composite outcome and a set of prespecified covariates. A split sample method will be adopted to validate the variables associated with OAC-related adverse events. ETHICS AND DISSEMINATION:The use of data in this project was authorised under section 45 of Ontario's Personal Health Information Protection Act, which does not require review by a research ethics board. Results will be disseminated via peer-reviewed publications and presentations at conferences and will determine intervention targets to improve OAC management in upcoming randomised trials. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identifier: NCT02777047; Pre-results.
| S-EPMC7509956 | biostudies-literature
Project description:BackgroundPreliminary studies have suggested that the renin-angiotensin system is activated in critical illness and associated with mortality and kidney outcomes. We sought to assess in a larger, multicenter study the relationship between serum renin and Major Adverse Kidney Events (MAKE) in intensive care unit (ICU) patients.MethodsProspective, multicenter study at two institutions of patients with and without acute kidney injury (AKI). Blood samples were collected for renin measurement a median of 2 days into the index ICU admission and 5-7 days later. The primary outcome was MAKE at hospital discharge, a composite of mortality, kidney replacement therapy, or reduced estimated glomerular filtration rate to ≤ 75% of baseline.ResultsPatients in the highest renin tertile were more severely ill overall, including more AKI, vasopressor-dependence, and severity of illness. MAKE were significantly greater in the highest renin tertile compared to the first and second tertiles. In multivariable logistic regression, this initial measurement of renin remained significantly associated with both MAKE as well as the individual component of mortality. The association of renin with MAKE in survivors was not statistically significant. Renin measurements at the second time point were also higher in patients with MAKE. The trajectory of the renin measurements between time 1 and 2 was distinct when comparing death versus survival, but not when comparing MAKE versus those without.ConclusionsIn a broad cohort of critically ill patients, serum renin measured early in the ICU admission is associated with MAKE at discharge, particularly mortality.
| S-EPMC8364694 | biostudies-literature
Project description:BACKGROUND:Lisfranc injuries are known to be rare and often overlooked injuries that can cause long-term disability and pain when missed or treated incorrectly. The wide variety of Lisfranc injuries ranges from subtle ligament distensions to open fracture dislocations. The treatment of Lisfranc joint injuries is still controversial and very little is known about what types of injury can be treated nonoperatively. The current literature provides only two randomized studies on dislocated Lisfranc injuries. These studies have shown that primary arthrodesis (PA) leads to a similar or better outcome and results in fewer secondary operations when compared with open reduction and internal fixation (ORIF) in ligamentous injuries. There have been no previous randomized studies of the nonoperative versus operative treatment of Lisfranc injuries. Therefore, the purpose of this study is to compare the operative and nonoperative treatment of non-dislocated Lisfranc injuries and to compare the ORIF and PA treatment of dislocated Lisfranc injuries. METHODS:This study is a prospective, randomized, national multi-center trial. The trial comprises two strata: Stratum I compares cast-immobilization versus open reduction and internal fixation (ORIF) treatment of non-dislocated Lisfranc joint injuries. Stratum II compares PA versus ORIF in the treatment of dislocated injuries of the Lisfranc joint. The main hypothesis of stratum I is that the nonoperative treatment of non-dislocated Lisfranc injuries achieves a similar outcome compared with operative treatment (ORIF). The hypothesis of stratum II is that PA of dislocated Lisfranc injuries yields a similar functional outcome compared with ORIF, but that PA results in fewer secondary operations than ORIF. The main outcome measure is the American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot score and the secondary outcome measures are Visual-Analogue-Scale Foot and Ankle (VAS-FA), Visual-Analogue-Scale (VAS), rate of secondary operations and other treatment-related complications. The results will be analyzed after the 2-year follow-up period. DISCUSSION:This publication presents a prospective, randomized, national multi-center trial study protocol. It provides details of patient flow, randomization, aftercare and methods of analysis of the material and ways to present and publish the results. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02953067 24.10.2016.
| S-EPMC6102864 | biostudies-literature
Project description:BackgroundLaparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction. Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients. However, no prospective, randomized, controlled trials comparing laparoscopy to open surgery have been published.Methods/designThis is a multicenter, prospective, open label, randomized, controlled trial comparing laparoscopic adhesiolysis to open surgery in patients with computed-tomography diagnosed adhesive small bowel obstruction that is not resolving with conservative management. The primary study endpoint is the length of postoperative hospital stay in days.Sample size was estimated based on preliminary retrospective cohort, which suggested that 102 patients would provide 80% power to detect a difference of 2.5 days in the length of postoperative hospital stay with significance level of 0.05. Secondary endpoints include passage of stool, commencement of enteral nutrition, 30-day mortality, complications, postoperative pain, and the length of sick leave. Tertiary endpoints consist of the rate of ventral hernia and the recurrence of small bowel obstruction during long-term follow-up. Long-term follow-up by letter or telephone interview will take place at 1, 5, and 10 years.DiscussionTo the best of our knowledge, this trial is the first one aiming to provide level Ib evidence to assess the use of laparoscopy in the treatment of adhesive small bowel obstruction.Trial registrationClinicalTrials.gov identifier: NCT01867528. Date of registration May 26th 2013.
| S-EPMC4198325 | biostudies-literature
Project description:Drug-drug interactions (DDIs) with oral anticoagulants may lead to under-anticoagulation and increased risk of thromboembolism. Although warfarin is susceptible to numerous DDIs, few studies have examined DDIs resulting in thromboembolism or those involving direct-acting oral anticoagulants (DOACs). We aimed to identify medications that increase the rate of hospitalization for thromboembolic events when taken concomitantly with oral anticoagulants. We conducted a high-throughput pharmacoepidemiologic screening study using Optum Clinformatics Data Mart, 2000-2016. We performed self-controlled case series studies among adult users of oral anticoagulants (warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban) with at least one hospitalization for a thromboembolic event. Among eligible patients, we identified all oral medications frequently co-prescribed with oral anticoagulants as potential interacting precipitants. Conditional Poisson regression was used to estimate rate ratios comparing precipitant exposed vs. unexposed time for each anticoagulant-precipitant pair. To minimize within-person confounding by indication for the precipitant, we used pravastatin as a negative control object drug. Multiple estimation was adjusted using semi-Bayes shrinkage. We screened 1,622 oral anticoagulant-precipitant drug pairs and identified 226 (14%) drug pairs associated with statistically significantly elevated risk of thromboembolism. Using pravastatin as the negative control object drug, this list was reduced to 69 potential DDI signals for thromboembolism, 33 (48%) of which were not documented in the DDI knowledge databases Lexicomp and/or Micromedex. There were more DDI signals associated with warfarin than DOACs. This study reproduced several previously documented oral anticoagulant DDIs and identified potential DDI signals that deserve to be examined in future etiologic studies.
| S-EPMC7765337 | biostudies-literature
Project description:BACKGROUND:The prescription of antipsychotics (AP), and especially second generation AP, is increasing worldwide in the pediatric population. Most prescriptions are off-label and despite the identification of frequent and potentially severe adverse events (AE), there are only a few guidelines for the safety management. France is one of the countries with no official safety guidelines. METHODS:Psychotropic drug-naive adolescents (13-18 years), hospitalized for an acute psychotic episode and treated with a second-generation antipsychotic were consecutively included in a prospective cohort study. Patients were assessed for their AE at baseline, 2, 6 and 12 weeks after the introduction of drug. RESULTS:The majority of patients was treated with risperidone (n?=?13), 2 with aripiprazole. The principal findings are: (1) A high incidence of neuromuscular AE: 8/15 muscle weakness, 8/15 extrapyramidal syndrome, 6/15 akathisia, 3/15 oro-facial acute dystonia; (2) Severe catatonia symptoms in 2 patients despite a low to moderate treatment dose, requiring transfer in intensive care unit for one; (3) Weight gain and significant increase of the BMI for all 13 patients who had a 12 weeks follow-up. CONCLUSION:All adolescents experienced AE, with significant weight gain being observed in all patients who completed the 12-week follow-up. The fact that our patient population was first episode drug naïve may partially explain this observation. Despite the limitation due to the small sample size of this prospective short-term study, such findings are important to report and warrant further research. CLINICAL AND RESEARCH IMPLICATION:Because of the lack of naturalistic follow up studies of antipsychotic treatments in AP-naive children and adolescents and the absence of safety guidelines for the pediatric population in France, we decided to continue our research at a national level. We therefore started a prospective, naturalistic and multicenter study funded by the French National Agency for Medicines and Health Products Safety (ANSM). Study purpose is to evaluate the incidence of adverse events related to antipsychotic drugs in AP-naive children and adolescents. In addition, we aim to provide further evidence for the necessity of national safety guidelines for AP prescription in the pediatric population.
| S-EPMC4078933 | biostudies-literature
Project description:BackgroundIn this study, we aimed to compare the effectiveness and adverse reactions of nirmatrelvir/ritonavir and molnupiravir in high-risk outpatients with coronavirus disease 2019 (COVID-19).MethodsThis multicenter prospective observational study evaluated the rate of hospitalization, death, and adverse events within 28 days of oral antiviral agent prescription (molnupiravir, n = 240; nirmatrelvir/ritonavir, n = 240) to 480 nonhospitalized adult patients with COVID-19 from August 2, 2022 to March 31, 2023.ResultsPatients receiving molnupiravir had a higher prevalence of comorbidities (85.8% vs. 70.4%; P < 0.001) and a higher Charlson comorbidity index (2.8 ± 1.4 vs. 2.5 ± 1.5; P = 0.009) than those receiving nirmatrelvir/ritonavir. Three patients required hospitalization (nirmatrelvir/ritonavir group, n = 1 [0.4%]; molnupiravir group, n = 2 [0.8%]; P = 1.000). Nirmatrelvir/ritonavir was associated with a higher risk of adverse events than molnupiravir (odds ratio [OR], 1.96; 95% confidence interval [CI], 1.27-3.03), especially for patients aged 65 years and older (OR, 3.04; 95% CI, 1.71-5.39). The severity of adverse events in both groups was mild to moderate and improved after discontinuation of medication. In the molnupiravir group, age ≥ 65 years (OR, 0.43 95% CI, 0.22-0.86) and appropriate vaccination (OR, 0.37; 95% CI, 0.15-0.91) reduced the occurrence of adverse events.ConclusionThe rates of hospitalization and death were low and not significantly different between high-risk patients who received either nirmatrelvir/ritonavir or molnupiravir. Although adverse events were more frequent with nirmatrelvir/ritonavir than with molnupiravir, none were severe. Nirmatrelvir/ritonavir can be safely used to treat COVID-19, while molnupiravir could be considered as an alternative treatment option for high-risk groups.
| S-EPMC10615643 | biostudies-literature
Project description:Direct oral anticoagulant (DOAC) use is growing as monotherapy and combined with platelet inhibitors. The safety of such combination therapy, especially in comparison to regimens including warfarin, in real world populations remains uncertain. We investigated hemorrhage associated with DOAC and antiplatelet combination therapy in a cohort of elderly coronary artery stent recipients. We employed Medicare data 2010-2013 for a 40% random sample of beneficiaries enrolled in inpatient, outpatient and prescription benefits. We used Cox proportional hazards models to examine the association of the combination anticoagulant (DOAC or warfarin) plus antiplatelets with major hemorrhage events (upper gastrointestinal or intracranial) in the 12?months following stent placement. We identified 70,900 stent recipients. 14.4% had atrial fibrillation (AF) diagnosis preoperatively. Among the 24.5 million observation days, exposure distribution was: 73.8% antiplatelets only, 4.7% antiplatelets plus warfarin, 0.6% antiplatelets plus DOAC, 2.2% warfarin only, 0.3% DOAC only and 18.4% no observed antiplatelets or anticoagulant. Overall, 8,029 patients (11.3%) experienced major hemorrhage. Among AF patients, compared to antiplatelets only, DOAC plus antiplatelets was associated with increased hemorrhage risk (HR, 1.94; 95%CI, 1.48-2.54); warfarin plus antiplatelets conferred comparable bleed risk (HR, 1.69; 95%CI, 1.47-1.94). In the non-AF group, compared to antiplatelets alone, combination DOAC plus antiplatelets (HR, 3.09; 95%CI, 2.15-4.46), and warfarin plus antiplatelets (HR, 2.21; 95%CI, 1.97-2.48) conferred greater bleed risk. Among elderly coronary artery stent recipients with AF, the two drug combinations, DOAC plus antiplatelets and warfarin plus antiplatelets, were associated with similarly increased risk of major hemorrhage compared to antiplatelets alone.
| S-EPMC5936642 | biostudies-literature