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1.
Blood Adv ; 2022 Feb 24.
Article in English | MEDLINE | ID: covidwho-1704478

ABSTRACT

Vaccine-induced immune thrombotic thrombocytopenia (VITT) is a rare complication after SARS-CoV-2 adenoviral vector vaccination. In British Columbia, a provincial clinical care pathway was developed to guide clinicians in evaluating for VITT among patients who present with thrombocytopenia or thrombosis symptoms within 4 to 28 days after adenoviral vector vaccine exposure. All patients had enzyme-linked immunosorbent assay (ELISA) testing for platelet factor 4 (PF4) antibodies and all cases with positive PF4-ELISA or D-dimer levels >2.0 mg/L fibrinogen equivalent units (FEU) had further testing for platelet-activating PF4 antibodies using a modified serotonin release assay (SRA). Between May 1 and June 30, 2021, 37% of 68 patients investigated for VITT had thrombosis but only 3 had VITT confirmed by PF4-ELISA and SRA. Platelet counts, D-dimer levels, and ELISA optical density values were significantly different between those with and without VITT. Three patients had thrombocytopenia and thrombosis with D-dimer levels >4.0 mg/L FEU but had negative PF4-ELISA and SRA results. Patients with VITT were treated successfully with intravenous immunoglobulin, non-heparin anticoagulants and corticosteroids. Our pathway demonstrated that thrombosis is common among patients investigated for VITT and that PF4-ELISA testing is necessary to confirm VITT in those presenting with thrombosis and thrombocytopenia.

2.
BMJ Open ; 11(12): e052019, 2021 12 17.
Article in English | MEDLINE | ID: covidwho-1583101

ABSTRACT

OBJECTIVE: The objective of this study was to estimate background rates of selected thromboembolic and coagulation disorders in Ontario, Canada. DESIGN: Population-based retrospective observational study using linked health administrative databases. Records of hospitalisations and emergency department visits were searched to identify cases using International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Canada diagnostic codes. PARTICIPANTS: All Ontario residents. PRIMARY OUTCOME MEASURES: Incidence rates of ischaemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage, deep vein thrombosis, pulmonary embolism, idiopathic thrombocytopaenia, disseminated intravascular coagulation and cerebral venous thrombosis during five prepandemic years (2015-2019) and 2020. RESULTS: The average annual population was 14 million with 51% female. The mean annual rates per 100 000 population during 2015-2019 were 127.1 (95% CI 126.2 to 127.9) for ischaemic stroke, 22.0 (95% CI 21.6 to 22.3) for intracerebral haemorrhage, 9.4 (95% CI 9.2 to 9.7) for subarachnoid haemorrhage, 86.8 (95% CI 86.1 to 87.5) for deep vein thrombosis, 63.7 (95% CI 63.1 to 64.3) for pulmonary embolism, 6.1 (95% CI 5.9 to 6.3) for idiopathic thrombocytopaenia, 1.6 (95% CI 1.5 to 1.7) for disseminated intravascular coagulation, and 1.5 (95% CI 1.4 to 1.6) for cerebral venous thrombosis. Rates were lower in 2020 than during the prepandemic years for ischaemic stroke, deep vein thrombosis and idiopathic thrombocytopaenia. Rates were generally consistent over time, except for pulmonary embolism, which increased from 57.1 to 68.5 per 100 000 between 2015 and 2019. Rates were higher for females than males for subarachnoid haemorrhage, pulmonary embolism and cerebral venous thrombosis, and vice versa for ischaemic stroke and intracerebral haemorrhage. Rates increased with age for most of these conditions, but idiopathic thrombocytopaenia demonstrated a bimodal distribution with incidence peaks at 0-19 years and ≥60 years. CONCLUSIONS: Our estimated background rates help contextualise observed events of these potential adverse events of special interest and to detect potential safety signals related to COVID-19 vaccines.


Subject(s)
Brain Ischemia , COVID-19 , Disseminated Intravascular Coagulation , Pulmonary Embolism , Stroke , Adolescent , Adult , COVID-19 Vaccines , Child , Child, Preschool , Emergency Service, Hospital , Female , Hospitalization , Humans , Incidence , Infant , Infant, Newborn , Male , Ontario/epidemiology , Pulmonary Embolism/epidemiology , SARS-CoV-2 , Stroke/epidemiology , Young Adult
3.
JAMA Neurol ; 78(11): 1314-1323, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1439655

ABSTRACT

Importance: Thrombosis with thrombocytopenia syndrome (TTS) has been reported after vaccination with the SARS-CoV-2 vaccines ChAdOx1 nCov-19 (Oxford-AstraZeneca) and Ad26.COV2.S (Janssen/Johnson & Johnson). Objective: To describe the clinical characteristics and outcome of patients with cerebral venous sinus thrombosis (CVST) after SARS-CoV-2 vaccination with and without TTS. Design, Setting, and Participants: This cohort study used data from an international registry of consecutive patients with CVST within 28 days of SARS-CoV-2 vaccination included between March 29 and June 18, 2021, from 81 hospitals in 19 countries. For reference, data from patients with CVST between 2015 and 2018 were derived from an existing international registry. Clinical characteristics and mortality rate were described for adults with (1) CVST in the setting of SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia, (2) CVST after SARS-CoV-2 vaccination not fulling criteria for TTS, and (3) CVST unrelated to SARS-CoV-2 vaccination. Exposures: Patients were classified as having TTS if they had new-onset thrombocytopenia without recent exposure to heparin, in accordance with the Brighton Collaboration interim criteria. Main Outcomes and Measures: Clinical characteristics and mortality rate. Results: Of 116 patients with postvaccination CVST, 78 (67.2%) had TTS, of whom 76 had been vaccinated with ChAdOx1 nCov-19; 38 (32.8%) had no indication of TTS. The control group included 207 patients with CVST before the COVID-19 pandemic. A total of 63 of 78 (81%), 30 of 38 (79%), and 145 of 207 (70.0%) patients, respectively, were female, and the mean (SD) age was 45 (14), 55 (20), and 42 (16) years, respectively. Concomitant thromboembolism occurred in 25 of 70 patients (36%) in the TTS group, 2 of 35 (6%) in the no TTS group, and 10 of 206 (4.9%) in the control group, and in-hospital mortality rates were 47% (36 of 76; 95% CI, 37-58), 5% (2 of 37; 95% CI, 1-18), and 3.9% (8 of 207; 95% CI, 2.0-7.4), respectively. The mortality rate was 61% (14 of 23) among patients in the TTS group diagnosed before the condition garnered attention in the scientific community and 42% (22 of 53) among patients diagnosed later. Conclusions and Relevance: In this cohort study of patients with CVST, a distinct clinical profile and high mortality rate was observed in patients meeting criteria for TTS after SARS-CoV-2 vaccination.


Subject(s)
COVID-19 Vaccines/therapeutic use , Drug-Related Side Effects and Adverse Reactions/mortality , Registries , Sinus Thrombosis, Intracranial/mortality , Thrombocytopenia/mortality , Venous Thromboembolism/mortality , Adult , Aged , COVID-19 Vaccines/adverse effects , Cohort Studies , Female , Hospital Mortality , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Sex Factors , Sinus Thrombosis, Intracranial/blood , Sinus Thrombosis, Intracranial/chemically induced , Syndrome , Thrombocytopenia/blood , Thrombocytopenia/chemically induced , Venous Thromboembolism/blood , Venous Thromboembolism/chemically induced , Young Adult
4.
JAMA ; 326(4): 332-338, 2021 07 27.
Article in English | MEDLINE | ID: covidwho-1355843

ABSTRACT

Importance: Cases of cerebral venous sinus thrombosis in combination with thrombocytopenia have recently been reported within 4 to 28 days of vaccination with the ChAdOx1 nCov-19 (AstraZeneca/Oxford) and Ad.26.COV2.S (Janssen/Johnson & Johnson) COVID-19 vaccines. An immune-mediated response associated with platelet factor 4/heparin antibodies has been proposed as the underlying pathomechanism. Objective: To determine the frequencies of admission thrombocytopenia, heparin-induced thrombocytopenia, and presence of platelet factor 4/heparin antibodies in patients diagnosed with cerebral venous sinus thrombosis prior to the COVID-19 pandemic. Design, Setting, and Participants: This was a descriptive analysis of a retrospective sample of consecutive patients diagnosed with cerebral venous sinus thrombosis between January 1987 and March 2018 from 7 hospitals participating in the International Cerebral Venous Sinus Thrombosis Consortium from Finland, the Netherlands, Switzerland, Sweden, Mexico, Iran, and Costa Rica. Of 952 patients, 865 with available baseline platelet count were included. In a subset of 93 patients, frozen plasma samples collected during a previous study between September 2009 and February 2016 were analyzed for the presence of platelet factor 4/heparin antibodies. Exposures: Diagnosis of cerebral venous sinus thrombosis. Main Outcomes and Measures: Frequencies of admission thrombocytopenia (platelet count <150 ×103/µL), heparin-induced thrombocytopenia (as diagnosed by the treating physician), and platelet factor 4/heparin IgG antibodies (optical density >0.4, in a subset of patients with previously collected plasma samples). Results: Of 865 patients (median age, 40 years [interquartile range, 29-53 years], 70% women), 73 (8.4%; 95% CI, 6.8%-10.5%) had thrombocytopenia, which was mild (100-149 ×103/µL) in 52 (6.0%), moderate (50-99 ×103/µL) in 17 (2.0%), and severe (<50 ×103/µL) in 4 (0.5%). Heparin-induced thrombocytopenia with platelet factor 4/heparin antibodies was diagnosed in a single patient (0.1%; 95% CI, <0.1%-0.7%). Of the convenience sample of 93 patients with cerebral venous sinus thrombosis included in the laboratory analysis, 8 (9%) had thrombocytopenia, and none (95% CI, 0%-4%) had platelet factor 4/heparin antibodies. Conclusions and Relevance: In patients with cerebral venous sinus thrombosis prior to the COVID-19 pandemic, baseline thrombocytopenia was uncommon, and heparin-induced thrombocytopenia and platelet factor 4/heparin antibodies were rare. These findings may inform investigations of the possible association between the ChAdOx1 nCoV-19 and Ad26.COV2.S COVID-19 vaccines and cerebral venous sinus thrombosis with thrombocytopenia.


Subject(s)
COVID-19 Vaccines/adverse effects , Heparin/immunology , Platelet Factor 4/immunology , Sinus Thrombosis, Intracranial/complications , Thrombocytopenia/etiology , Adult , Antibodies/blood , Female , Heparin/adverse effects , Humans , Male , Middle Aged , Retrospective Studies , Sinus Thrombosis, Intracranial/immunology , Thrombocytopenia/epidemiology
5.
JAMA ; 326(4): 332-338, 2021 07 27.
Article in English | MEDLINE | ID: covidwho-1293117

ABSTRACT

Importance: Cases of cerebral venous sinus thrombosis in combination with thrombocytopenia have recently been reported within 4 to 28 days of vaccination with the ChAdOx1 nCov-19 (AstraZeneca/Oxford) and Ad.26.COV2.S (Janssen/Johnson & Johnson) COVID-19 vaccines. An immune-mediated response associated with platelet factor 4/heparin antibodies has been proposed as the underlying pathomechanism. Objective: To determine the frequencies of admission thrombocytopenia, heparin-induced thrombocytopenia, and presence of platelet factor 4/heparin antibodies in patients diagnosed with cerebral venous sinus thrombosis prior to the COVID-19 pandemic. Design, Setting, and Participants: This was a descriptive analysis of a retrospective sample of consecutive patients diagnosed with cerebral venous sinus thrombosis between January 1987 and March 2018 from 7 hospitals participating in the International Cerebral Venous Sinus Thrombosis Consortium from Finland, the Netherlands, Switzerland, Sweden, Mexico, Iran, and Costa Rica. Of 952 patients, 865 with available baseline platelet count were included. In a subset of 93 patients, frozen plasma samples collected during a previous study between September 2009 and February 2016 were analyzed for the presence of platelet factor 4/heparin antibodies. Exposures: Diagnosis of cerebral venous sinus thrombosis. Main Outcomes and Measures: Frequencies of admission thrombocytopenia (platelet count <150 ×103/µL), heparin-induced thrombocytopenia (as diagnosed by the treating physician), and platelet factor 4/heparin IgG antibodies (optical density >0.4, in a subset of patients with previously collected plasma samples). Results: Of 865 patients (median age, 40 years [interquartile range, 29-53 years], 70% women), 73 (8.4%; 95% CI, 6.8%-10.5%) had thrombocytopenia, which was mild (100-149 ×103/µL) in 52 (6.0%), moderate (50-99 ×103/µL) in 17 (2.0%), and severe (<50 ×103/µL) in 4 (0.5%). Heparin-induced thrombocytopenia with platelet factor 4/heparin antibodies was diagnosed in a single patient (0.1%; 95% CI, <0.1%-0.7%). Of the convenience sample of 93 patients with cerebral venous sinus thrombosis included in the laboratory analysis, 8 (9%) had thrombocytopenia, and none (95% CI, 0%-4%) had platelet factor 4/heparin antibodies. Conclusions and Relevance: In patients with cerebral venous sinus thrombosis prior to the COVID-19 pandemic, baseline thrombocytopenia was uncommon, and heparin-induced thrombocytopenia and platelet factor 4/heparin antibodies were rare. These findings may inform investigations of the possible association between the ChAdOx1 nCoV-19 and Ad26.COV2.S COVID-19 vaccines and cerebral venous sinus thrombosis with thrombocytopenia.


Subject(s)
COVID-19 Vaccines/adverse effects , Heparin/immunology , Platelet Factor 4/immunology , Sinus Thrombosis, Intracranial/complications , Thrombocytopenia/etiology , Adult , Antibodies/blood , Female , Heparin/adverse effects , Humans , Male , Middle Aged , Retrospective Studies , Sinus Thrombosis, Intracranial/immunology , Thrombocytopenia/epidemiology
6.
J Int Neuropsychol Soc ; 26(10): 1045-1050, 2020 11.
Article in English | MEDLINE | ID: covidwho-949638

ABSTRACT

OBJECTIVE: To evaluate an abbreviated NIH Toolbox Cognition Battery (NIHTB-CB) protocol that can be administered remotely without any in-person assessments, and explore the agreement between prorated scores from the abbreviated protocol and standard scores from the full protocol. METHODS: Participant-level age-corrected NIHTB-CB data were extracted from six studies in individuals with a history of stroke, mild traumatic brain injury (mTBI), treatment-resistant psychosis, and healthy controls, with testing administered under standard conditions. Prorated fluid and total cognition scores were estimated using regression equations that excluded the three fluid cognition NIHTB-CB instruments which cannot be administered remotely. Paired t tests and intraclass correlations (ICCs) were used to compare the standard and prorated scores. RESULTS: Data were available for 245 participants. For fluid cognition, overall prorated scores were higher than standard scores (mean difference = +4.5, SD = 14.3; p < 0.001; ICC = 0.86). For total cognition, overall prorated scores were higher than standard scores (mean difference = +2.7, SD = 8.3; p < 0.001; ICC = 0.88). These differences were significant in the stroke and mTBI groups, but not in the healthy control or psychosis groups. CONCLUSIONS: Prorated scores from an abbreviated NIHTB-CB protocol are not a valid replacement for the scores from the standard protocol. Alternative approaches to administering the full protocol, or corrections to scoring of the abbreviated protocol, require further study and validation.


Subject(s)
Brain Injuries, Traumatic/psychology , Cognition Disorders/diagnosis , Cognition/physiology , National Institutes of Health (U.S.) , Neuropsychological Tests/standards , Adult , Female , Humans , Male , Middle Aged , Psychometrics , Reproducibility of Results , Sensitivity and Specificity , United States , Young Adult
7.
CJC Open ; 2(4): 265-272, 2020 Jul.
Article in English | MEDLINE | ID: covidwho-549011

ABSTRACT

BACKGROUND: The literature indicates that cardiovascular disease (CVD; including stroke), older age, and availability of health care resources affect COVID-19 case fatality rates (CFRs). The cumulative effect of COVID-19 CFRs in global CVD populations and the extrapolated effect on access to health care services in the CVD population in Canada are not fully known. In this study we explored the relationships of factors that might affect COVID-19 CFRs and estimated the potential indirect effects of COVID-19 on Canadian health care resources. METHODS: Country-level epidemiological data were analyzed to study the correlation, main effect, and interaction between COVID-19 CFRs and: (1) the proportion of the population with CVD; (2) the proportion of the population 65 years of age or older; and (3) the availability of essential health services as defined by the World Health Organization Universal Health Coverage index. For indirect implications on health care resources, estimates of the volume of postponed coronary artery bypass grafting, percutaneous coronary intervention, and valve surgeries in Ontario were calculated. RESULTS: Positive correlations were found between COVID-19 CFRs and: (1) the proportion of the population with CVD (ρ = 0.40; P = 0.001); (2) the proportion of the population 65 years of age or older (ρ = 0.43; P = 0.0005); and (3) Universal Health Coverage index (ρ = 0.27; P = 0.03). For every 1% increase in the proportion of the population 65 years of age or older or proportion of the population with CVD, the COVID-19 CFR was 9% and 19% higher, respectively. Approximately 1252 procedures would be postponed monthly in Ontario because of current public health measures. CONCLUSIONS: Countries with more prevalent CVD reported higher COVID-19 CFRs. Strain on health care resources is likely in Canada.


CONTEXTE: La littérature indique que les maladies cardiovasculaires (MCV, incluant les accidents vasculaires cérébraux), l'âge avancé et la facilité d'accès aux ressources de soins de santé ont une incidence sur les taux de létalité (TL) des cas de COVID-19. L'effet cumulatif du TL de la COVID-19 dans l'ensemble de la population atteinte de MCV et l'impact anticipé sur l'accès aux services de santé dans la population atteinte de MCV au Canada ne sont pas entièrement connus. Cette étude a exploré les liens entre les facteurs pouvant influencer le TL des cas de COVID-19 et a estimé le potentiel impact indirect de la COVID-19 sur les ressources de soins de santé au Canada. MÉTHODES: Les données épidémiologiques à l'échelle du pays ont été analysées pour étudier la corrélation, l'effet principal et l'interaction entre le TL de laCOVID-19 et : 1) la proportion de la population souffrant de MCV, 2) la proportion de la population ≥ 65 ans, et 3) l'accessibilité des services de santé essentiels tels que définis par l'indice de couverture sanitaire universelle (CSU) de l'Organisation Mondiale de la Santé. Pour les implications indirectes concernant les ressources de santé, des estimations du volume d'opération de pontages coronariens, d'interventions coronariennes percutanées et de chirurgies valvulaires reportées en Ontario ont été calculées. RÉSULTATS: Des corrélations positives ont été trouvées entre le TL de la COVID-19 et 1) la proportion de la population souffrant de MCV (ρ= 0,40, P = 0,001), 2) la proportion de la population ≥ 65 ans (ρ= 0,43, P = 0,0005), et 3) l'indice CSU (ρ= 0,27, P = 0,03). Pour chaque augmentation de 1 % de la proportion de la population ≥ 65 ans ou de la proportion de la population souffrant de MCV, le TL de la COVID-19 était respectivement supérieur de 9 % et 19 %. Environ 1 252 interventions seraient reportées chaque mois en Ontario en raison des mesures de santé publique actuelles. CONCLUSIONS: Les pays où les MCV sont plus répandues ont signalé un TL de la COVID-19 plus élevé. Il est probable que les ressources de soins de santé soient soumises à de fortes contraintes au Canada.

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