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Trials Jan 2021Oral anticoagulant drugs represent an essential tool in the prevention of thromboembolic events. The ones in widespread use are vitamin K antagonists, whose plasma level...
Efficacy of a joint didactic intervention using the Junta De Andalucía School for Patients method to control prothrombin time in patients taking anticoagulants: protocol for a randomized controlled trial.
BACKGROUND
Oral anticoagulant drugs represent an essential tool in the prevention of thromboembolic events. The ones in widespread use are vitamin K antagonists, whose plasma level is monitored by measuring prothrombin time using the international normalized ratio. If its values are out of the recommended range, the patient will have a higher risk of suffering from thromboembolic or hemorrhagic complications. Previous research has shown that approximately 33% of patients keep having values at an inappropriate level. The purpose of the proposed study is to improve the international normalized ratio control results by a joint didactic intervention based on the Junta de Andalucía School for Patients method that will be implemented by anticoagulated patients themselves.
METHODS
A randomized controlled trial will be undertaken at primary care centers from one healthcare area in Málaga (Andalusia, Spain).
STUDY POPULATION
patients participating in an oral anticoagulant therapy program of vitamin K antagonists. First step: identification of patients in the oral anticoagulation therapy program with international normalized ratio control of the therapeutic level at 65% or less over total time. Second step: patients with international normalized ratio (INR) control figures under 2 or above 3 will be assigned to two different groups: Group 1 or joint intervention group: patients will be instructed in the joint didactic "from peer to peer," by a previously trained and expert anticoagulant patient. Group 2 or control group: the control group will receive the usual clinical practice. They will be evaluated by nurses about once a month, except for cases in which their INR figures are under 2 or above 3, and those patients will be evaluated more frequently. A total of 312 individuals will be required (156 in each group) to detect differences in INR figures equal to or higher than 15% between the groups.
STUDY VARIABLES
time on therapeutic levels before and after the intervention; sociodemographic variables; vital signs; the existence of cardiovascular risk factors or accompanying diseases in the clinical records; laboratory test including complete blood counts, bleeding time, and prothrombin time or partial thromboplastin time; and blood chemistry, other prescribed drugs, and social support. A quasi-experimental analytic study with before-after statistical analysis of the intervention will be conducted. Linear regression models will be applied for the main variable results (international normalized ratio value, time on therapeutic level) inputting sociodemographic variables, accompanying diseases, and social support.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03647254 . Registered on 27 August 2018.
Topics: Anticoagulants; Humans; International Normalized Ratio; Prothrombin Time; Randomized Controlled Trials as Topic; Schools; Spain
PubMed: 33430922
DOI: 10.1186/s13063-020-04972-1 -
PloS One 2021The study examined the Drug-Related Problems (DRPs) of patients with polypharmacy in 78 Hungarian community pharmacies, especially the interaction risks in terms of...
Analysis of interaction risks of patients with polypharmacy and the pharmacist interventions performed to solve them-A multicenter descriptive study according to medication reviews in Hungarian community pharmacies.
OBJECTIVE
The study examined the Drug-Related Problems (DRPs) of patients with polypharmacy in 78 Hungarian community pharmacies, especially the interaction risks in terms of their clinical severity. Also, the objective was to analyze pharmacists' interventions to solve the identified interaction risks.
METHODOLOGY
The research was carried out in the framework of the training of specialist pharmacists at Semmelweis University, with the participation of 78 graduated pharmacists with the collaboration of 98 GPs. A total of 755 patients participated in pharmaceutical counseling which meant a medication review process. DRPs were uniformly categorized and the interventions were recorded by pharmacists, while a detailed analysis of interaction risks was performed by authors.
RESULTS
A total of 984 DRPs were registered. The most common category of DRPs was the "non-quantitative safety problems" (62.6%). Interaction risk was the most common cause of DRPs (54.0%). The highest proportion of interaction risks were between two prescription drugs (66.7%). In 30.7% of interaction risks' cases, there was not known negative outcome. In contrast, it was recommended to modify the therapy in 14.9% of interaction risks. Acetylsalicylic acid (22.8%), acenocoumarol (17.7%), and diclofenac (13.9%) were the most common active substances which caused serious interaction risks. A total of 599 pharmacist interventions were used to solve the 531 interaction risks. Pharmacists notified the GPs about the problem in 28.4% of cases and they intervened without the GP in 63.1% of cases, most often with patient education (27.4%).
CONCLUSION
Medication review by community pharmacists is required for the safe medicine using of patients with polypharmacy, as a significant number of DRPs have been recorded. The incidence of interaction risks stood out. It is essential to develop a pharmaceutical guideline to properly classify the clinical relevance of interaction risks (e.g. according to high-risk active substances) and to increase the collaboration with GPs.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Community Pharmacy Services; Female; Humans; Hungary; Male; Middle Aged; Pharmacists; Polypharmacy; Practice Patterns, Pharmacists'; Risk Factors; Young Adult
PubMed: 34157039
DOI: 10.1371/journal.pone.0253645 -
Actas Dermo-sifiliograficas Apr 2021Recent years have seen important advances in our understanding of calciphylaxis, especially regarding newly identified risk factors and histologic findings that may aid...
Recent years have seen important advances in our understanding of calciphylaxis, especially regarding newly identified risk factors and histologic findings that may aid diagnosis. This retrospective study of cases of calciphylaxis treated in our hospital in the last 13 years focuses on newly revealed aspects of this disease. We describe 16 patients (62.5% women; mean age, 67.9 years). In addition to advanced kidney disease (in 75% of our patients), other factors associated with the presence of calciphylaxis were a history of treatments related to phosphorus and calcium metabolism (75%) and anticoagulation (62.5%), usually with vitamin-K antagonists. Histology showed alterations in elastic fibers in only 25% of the biopsy specimens. Eleven of the patients died: sepsis was most often the cause.
PubMed: 33939992
DOI: 10.1016/j.ad.2020.08.014 -
Revista de Neurologia May 2021The presence of air in vascular structures of the brain can lead to neurological symptoms and significant morbidity. It usually occurs as a consequence of invasive...
INTRODUCTION
The presence of air in vascular structures of the brain can lead to neurological symptoms and significant morbidity. It usually occurs as a consequence of invasive therapeutic procedures and is very rarely triggered by any other cause.
CASE REPORT
We report the case of a 76-year-old woman with a history of atrial fibrillation anticoagulated with acenocoumarol who visited the Emergency department because of sudden-onset abdominal pain, vomiting and diarrhoea. After starting symptomatic treatment and finding analytical evidence of underdosing of the anticoagulant, she suddenly presented with neurological focus. A cranial computed tomography scan revealed an acute intraparenchymal haemorrhage. The patient was transferred to the stroke unit of the referral hospital. Within a few hours, she developed haemodynamic instability due to a septic shock that had its origin in the abdomen. A computed tomography scan of the abdomen evidenced extensive pneumatosis intestinalis and an obstruction of contrast indicating mesenteric ischaemia. A mechanical thrombectomy was performed in an attempt to embolise the thrombus at a more distal level, but the patient died.
CONCLUSIONS
Mesenteric ischaemia can cause significant pneumatosis intestinalis, which, by a retrograde mechanism through the portal system, can cause air bubbles to reach the cerebral venous system, leading to acute stroke.
Topics: Aged; Cerebral Veins; Embolism, Air; Female; Humans; Intracranial Hemorrhages; Mesenteric Ischemia
PubMed: 33908620
DOI: 10.33588/rn.7209.2020652 -
Revista de Neurologia Sep 2021Spontaneous intracerebral haemorrhage associated with oral anticoagulants (ICH-OAC) has a high mortality rate. The emergence of new anticoagulant drugs and reversal... (Observational Study)
Observational Study
INTRODUCTION
Spontaneous intracerebral haemorrhage associated with oral anticoagulants (ICH-OAC) has a high mortality rate. The emergence of new anticoagulant drugs and reversal protocols increases interest in this entity.
OBJECTIVES
The main objective is to determine the mortality rate in patients with ICH-OAC (early, in-hospital, global) in our health area and to analyse the main variables related to it. The secondary objective is to determine the efficacy of anticoagulation reversal therapies (ART) as reflected by radiological expansion of the haematoma and the functional prognosis.
PATIENTS AND METHODS
A prospective observational study that introduced a protocol aimed at the management of patients with ICH-OAC. It included general measures and neuromonitoring, individualised administration of ART, cranial tomography and a six-month follow-up. Data on the drugs prescribed in the area during this period, mortality and functional prognosis were collected. A bivariate and logistic regression study was designed to investigate mortality-related variables.
RESULTS
Forty-nine patients were included over three years; of these, 71.4% received ART. Mortality was 16.3% (first 24 hours), 53.1% (admission) and 61.2% (180 days). Lower survival was observed among patients with higher baseline scores on the National Institutes of Health Stroke Scale (NIHSS) (p < 0.0001), creatinine value (p = 0.02), International Normalised Index (p = 0.048), bleeding volume (p = 0.008), hydrocephalus (p = 0.015) and acenocoumarol intake (p = 0.030). Patients who did not receive ART had a greater rate of early mortality (p = 0.003). The only variable independently related to overall mortality was the baseline NIHSS score (odds ratio = 1.282; 95% confidence interval: 1.023-1.608; p = 0.031).
CONCLUSIONS
ICH-OAC has a high mortality rate, related to the use of acenocoumarol and regardless of the initial clinical situation. A lower rate of early mortality was found among patients who received ART.
Topics: Aged; Aged, 80 and over; Anticoagulants; Anticoagulation Reversal; Antidotes; Cerebral Hemorrhage; Clinical Protocols; Factor Xa Inhibitors; Female; Follow-Up Studies; Hospital Mortality; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Neuroimaging; Prospective Studies; Severity of Illness Index; Tertiary Care Centers; Thromboembolism; Tomography, X-Ray Computed; Treatment Outcome; Vitamin K
PubMed: 34328205
DOI: 10.33588/rn.7305.2020565 -
Medicine Sep 2020Anticoagulant therapy is used for stroke prevention and proved to be effective and safe in the long term. The study aims to analyse the cost-effectiveness relationship... (Comparative Study)
Comparative Study Randomized Controlled Trial
Cost-effectiveness of direct oral anticoagulants versus vitamin K antagonist in atrial fibrillation: A study protocol using Real-World Data from Catalonia (FantasTIC Study).
BACKGROUND
Anticoagulant therapy is used for stroke prevention and proved to be effective and safe in the long term. The study aims to analyse the cost-effectiveness relationship of using of direct-acting oral anticoagulants vs vitamin K antagonists to prevent ischaemic stroke in patients with nonvalvular atrial fibrillation, including all the active ingredients marketed in Spain, prescribed for 2 years in the Primary Care service of the Institut Català de la Salut.
METHODS
Population-based cohort study, in which the cost of the 2 treatment groups will be evaluated. Direct costs (pharmacy, primary care, emergency and hospitalization) and indirect costs (lost productivity) will be included from a social perspective. Effectiveness (assessed as the occurrence of a health event, the 1 of primary interest being stroke) will be determined, with a 2-year time horizon and a 3% discount rate. The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs. We will carry out a univariate ('one-way') deterministic sensitivity analysis.
DISCUSSION
We hope to provide relevant information about direct and indirect costs of oral anticoagulants, which, together with aspects of effectiveness and safety, could help shape the consensual decision-making of evaluating bodies.
Topics: Acenocoumarol; Administration, Oral; Anticoagulants; Atrial Fibrillation; Brain Ischemia; Cost-Benefit Analysis; Factor Xa Inhibitors; Humans; Pragmatic Clinical Trials as Topic; Primary Health Care; Safety; Spain; Stroke; Treatment Outcome; Vitamin K; Warfarin
PubMed: 32899067
DOI: 10.1097/MD.0000000000022054 -
The Pan African Medical Journal 2021Vitamin K antagonists (VKA) based oral anticoagulation, is widely used for the prevention and treatment of thromboembolic disease. The major complication of this therapy...
Vitamin K antagonists (VKA) based oral anticoagulation, is widely used for the prevention and treatment of thromboembolic disease. The major complication of this therapy is bleeding, and sometimes it can occur in unsuspected areas. Spontaneous pectoral hematoma is one of the rare complications due to over anticoagulation by VKA therapy, with only a few cases reported in the literature. Concomitant use of this therapy with commonly used antibiotic, especially in the elderly with multiple comorbidities, can increase the risk of bleeding. Herein, we report a case of a 72-year-old woman under VKA for the treatment of atrial fibrillation, who presented with a spontaneous massive pectoral hematoma, while using antibiotic to treat a respiratory tract infection, who was successfully managed.
Topics: Acenocoumarol; Aged; Anticoagulants; Atrial Fibrillation; Female; Hematoma; Hemorrhage; Humans; Thromboembolism; Vitamin K
PubMed: 34285747
DOI: 10.11604/pamj.2021.38.324.28454 -
Cureus Feb 2024Warm antibody autoimmune hemolytic anemia (WAIHA) is a rare disease that leads to the destruction of red blood cells in the reticuloendothelial system through the...
Warm antibody autoimmune hemolytic anemia (WAIHA) is a rare disease that leads to the destruction of red blood cells in the reticuloendothelial system through the mediation of agglutinins (immunoglobulin G (IgG) type in most cases) that attach to the erythrocyte wall at 37 °C. The association of WAIHA and venous thromboembolism (VTE) seems to be higher than other hemolytic disorders classically associated with VTE and there is a current investigation aimed at clarifying this association and establishing some criteria to use anticoagulant treatment in patients with WAIHA. Despite this, WAIHA is a rare cause for the development of recurrent VTE under secondary prophylactic anticoagulant treatment, with only a few cases described in the literature. We present the case of a patient who developed a recurrence of deep vein thrombosis during a WAIHA episode despite treatment with acenocoumarol and a review of the literature.
PubMed: 38500896
DOI: 10.7759/cureus.54361 -
BMC Ophthalmology Feb 2022Our purpose was to describe a patient who developed combined central retinal vein occlusion (CRVO), cilioretinal artery occlusion, branch retinal artery occlusion...
Heterozygous factor V Leiden mutation manifesting with combined central retinal vein occlusion, cilioretinal artery occlusion, branch retinal artery occlusion, and anterior ischaemic optic neuropathy: a case report.
BACKGROUND
Our purpose was to describe a patient who developed combined central retinal vein occlusion (CRVO), cilioretinal artery occlusion, branch retinal artery occlusion (BRAO), and anterior ischaemic optic neuropathy (AION) followed by CRVO in the second eye because of the heterozygous factor V Leiden (FVL) mutation.
CASE PRESENTATION
A 39-year-old female with a history of recurrent pregnancy losses presented with acute blurred vision in the right eye (RE), with visual acuity limited to counting fingers. She was diagnosed with combined impending CRVO, cilioretinal artery occlusion, BRAO, and AION. The results of thrombophilia testing, not including the FVL mutation, were negative. Retinal atrophy with vascular attenuation and optic disc pallor developed after resolution of acute retinal findings. Nine months after initial presentation, the patient developed an impending CRVO in the left eye (LE), with a secondary progression to a complete CRVO causing a decrease in best corrected visual acuity (BCVA) to 20/40. The patient was determined to be heterozygous for the FVL mutation. She subsequently was treated with acenocoumarol. At the last follow-up visit, the BCVA was 20/400 in the RE and 20/20 in the LE, and there was a complete resolution of the acute CRVO findings in the LE.
CONCLUSION
Our case shows that the heterozygous FVL mutation may manifest with combined retinal vascular occlusion involving multiple sites in both eyes. Early recognition of such an inherited thrombophilic disorder is important because it implies the need for long-term anticoagulative therapy to reduce the patient's risk of recurrent, sight-threatening and life-threatening thrombotic events.
Topics: Adult; Arteries; Factor V; Female; Humans; Mutation; Optic Neuropathy, Ischemic; Retina; Retinal Artery Occlusion; Retinal Vein Occlusion; Thrombophilia
PubMed: 35123430
DOI: 10.1186/s12886-022-02278-1 -
The Pan African Medical Journal 2021Myocardial infarction is a life-threatening emergency with a high mortality rate. A high plasma level of factor VIII is an established risk for both arterial and venous...
Myocardial infarction is a life-threatening emergency with a high mortality rate. A high plasma level of factor VIII is an established risk for both arterial and venous thrombotic events. In this mini-review, we report the case of a 41-year-old woman without cardiovascular risk factors or a previous history of thrombotic events, admitted for ST-elevation myocardial infarction, in whom coronary angiography showed a thrombotic occlusion in the left anterior descending artery. The patient underwent primary percutaneous coronary intervention (PCI), with GPIIB-IIIA antagonist, then, a pre-dilation with a semi-compliant balloon-catheter, followed by implantation of 2 stents. The etiological assessment revealed a high level of coagulation factor VIII (FVIII). She underwent anticoagulation therapy (with acenocoumarol) with well-controlled international normalised ratio (INR).
Topics: Acenocoumarol; Adult; Anticoagulants; Coronary Angiography; Factor VIII; Female; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; ST Elevation Myocardial Infarction; Stents; Thrombosis
PubMed: 33995813
DOI: 10.11604/pamj.2021.38.207.28011