scholarly journals Background incidence rates of hospitalisations and emergency department visits for thromboembolic and coagulation disorders in Ontario, Canada for COVID-19 vaccine safety assessment: a population-based retrospective observational study

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052019
Author(s):  
Sharifa Nasreen ◽  
Andrew J Calzavara ◽  
Maria E Sundaram ◽  
Shannon E MacDonald ◽  
Christiaan H Righolt ◽  
...  

ObjectiveThe objective of this study was to estimate background rates of selected thromboembolic and coagulation disorders in Ontario, Canada.DesignPopulation-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.ParticipantsAll Ontario residents.Primary outcome measuresIncidence 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.ResultsThe 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.ConclusionsOur 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.

2021 ◽  
Author(s):  
Sharifa Nasreen ◽  
Andrew Calzavara ◽  
Maria Sundaram ◽  
Shannon E. MacDonald ◽  
Christiaan Righolt ◽  
...  

AbstractObjectiveThe objective of this study was to estimate background rates of selected thromboembolic and coagulation disorders in Ontario, Canada.DesignPopulation-based retrospective observational study using linked health administrative databases. Records of hospitalizations and emergency department visits were searched to identify cases using diagnostic codes from the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Canada (ICD-10-CA).ParticipantsAll Ontario residents.Primary outcome measuresIncidence rates of stroke, deep vein thrombosis, pulmonary embolism, idiopathic thrombocytopenia, disseminated intravascular coagulation, and cerebral venous thrombosis during five pre-pandemic years (2015–2019, annually, averaged, and monthly average) and 2020.ResultsThe average annual population was 14 million with 51% female. The mean annual rates during 2015–2019 were 127.1/100,000 population (95% confidence interval [CI], 126.2, 127.9) for ischemic stroke, 22.0/100,000 (95%CI, 21.6, 22.3) for intracerebral haemorrhage, 9.4 (95%CI, 9.2, 9.7) for subarachnoid haemorrhage, 86.8/100,000 (95%CI, 86.1, 87.5) for deep vein thrombosis, 63.7/100,000 (95%CI, 63.1, 64.3) for pulmonary embolism, 6.1/100,000 (95%CI, 5.9, 6.3) for idiopathic thrombocytopenia, 1.6/100,000 (95%CI, 1.5, 1.7) for disseminated intravascular coagulation, and 1.5/100,000 (95%CI, 1.4, 1.6) for cerebral venous thrombosis. Rates were lower in 2020 than during the pre-pandemic years for ischemic stroke, deep vein thrombosis, and idiopathic thrombocytopenia. 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 ischemic stroke and intracerebral haemorrhage. Rates increased with age for most of these conditions, but idiopathic thrombocytopenia demonstrated a bimodal distribution with incidence peaks at 0–19 years and ≥60 years.ConclusionsOur estimated background rates help to contextualize observed events of these potential adverse events of special interest and to detect potential safety signals related to COVID-19 vaccines.Strengths and limitations of this study➢Recent background rates of selected thromboembolic and coagulation disorders that are potential adverse events special interest related to COVID-19 vaccine are estimated.➢Background rates during five pre-pandemic (2015–2019) years and 2020 will provide context for these events to identify vaccine safety signals.➢We used recorded diagnostic codes in administrative data without information on clinical and/or diagnostic confirmation, and the validity of these data are imperfect, which may result in under or overestimation.


1972 ◽  
Vol 10 (23) ◽  
pp. 89-91

Earlier this year1 we discussed the prevention and treatment of venous thrombosis and concluded that heparin in low dosage seemed the most promising drug for preventing deep-vein thrombosis postoperatively, although the optimum regimen was not yet known. Sharnoff and his associates who began this work 10 years ago claim to have shown that this treatment largely prevents fatal pulmonary embolism.2


2006 ◽  
Vol 96 (08) ◽  
pp. 149-153 ◽  
Author(s):  
Sang Kim ◽  
Dong Lee ◽  
Choong Kim ◽  
Hyun Moon ◽  
Youngro Byun

SummaryThe use of heparin as the most potent anticoagulant for the prevention of deep vein thrombosis and pulmonary embolism is nevertheless limited, because it is available to patients only by parenteral administration. Toward overcoming this limitation in the use of heparin, we have previously developed an orally active heparin-deoxycholic acid conjugate (LMWH-DOCA) in 10% DMSO formulation. The present study evaluates the anti-thrombogenic effect of this orally active LMWH-DOCA using a venous thrombosis animal model with Sprague-Dawley rats. When 5 mg/kg of LMWH-DOCA was orally administered in rats, the maximum anti-FXa activity in plasma was 0. 35 ± 0. 02, and anti-FXa activity in plasma was maintained above 0. 1 IU/ml [the minimum effective anti-FXa activity for the prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE)] for five hours. LMWH-DOCA (5 mg/kg, 430 IU/kg) that was orally administered reduced the thrombus formation by 56. 3 ± 19. 8%;on the other hand, subcutaneously administered enoxaparin (100 IU/kg) reduced the thrombus formation by 36. 4 ± 14. 5%. Also, LMWH-DOCA was effectively neutralized by protamine that was used as an antidote. Therefore, orally active LMWH-DOCA could be proposed as a new drug that is effective for the longterm prevention of DVT and PE.


2018 ◽  
Author(s):  
Albeir Y Mousa

Acute deep venous thrombosis (DVT) of iliofemoral segment is one of the most dreaded presentations of venous thromboembolism, as it can not only compromise the function of the extremity but may also result in pulmonary embolism and even death. There are many causes for acute iliofemoral DVT, including underdiagnosed May-Thurner syndrome, hypercoagulable syndrome, and external compression on iliocaval segment. The available treatment depends on the acuity of the symptoms. Acute iliofemoral DVT can be treated with medical anticoagulation, pharmacomechanical therapy, including thrombolysis or surgical thrombectomy. Chronic iliofemoral occlusion may be treated with recanalization of the occluded segments with angioplasty stenting. This review contains 4 Figures, 4 Tables and 63 references Key Words: acute, angioplasty, deep venous thrombosis, iliofemoral, inferior vena cava, pharmacomechanical therapy, occlusion, stent


2018 ◽  
Author(s):  
Albeir Y Mousa

Acute deep venous thrombosis (DVT) of iliofemoral segment is one of the most dreaded presentations of venous thromboembolism, as it can not only compromise the function of the extremity but may also result in pulmonary embolism and even death. There are many causes for acute iliofemoral DVT, including underdiagnosed May-Thurner syndrome, hypercoagulable syndrome, and external compression on iliocaval segment. The available treatment depends on the acuity of the symptoms. Acute iliofemoral DVT can be treated with medical anticoagulation, pharmacomechanical therapy, including thrombolysis or surgical thrombectomy. Chronic iliofemoral occlusion may be treated with recanalization of the occluded segments with angioplasty stenting. This review contains 4 Figures, 4 Tables and 63 references Key Words: acute, angioplasty, deep venous thrombosis, iliofemoral, inferior vena cava, pharmacomechanical therapy, occlusion, stent


1992 ◽  
Vol 7 (2) ◽  
pp. 64-66 ◽  
Author(s):  
M. Lea Thomas ◽  
G. Solis

Objective: To assess the distribution of deep vein thrombosis in the calf by phlebography. Setting: Department of Vascular Radiology, St. Thomas' Hospital, London, England. Patients: Seventy patients with suspected deep vein thrombosis or pulmonary embolism were examined. Interventions: Bilateral ascending contrast phlebography was performed in all patients. Main Outcome Measures: The sites of any thrombus in the stem or muscle veins of the calf below the popliteal vein were recorded. Results: One hundred legs contained thrombus. In fifty-three legs thrombus was present solely in the calf veins below the popliteal vein. Isolated thrombus in either one or more of the three paired stem veins or the muscle veins was present in twenty-two calves. Conclusions: Because of the difficulty in visualising some calf veins by duplex ultrasound it is suggested that a detailed knowledge of the distribution of thrombus may assist ultrasonographers.


2011 ◽  
Vol 106 (12) ◽  
pp. 1084-1094. ◽  
Author(s):  
Keun-Wook Lee ◽  
Soo-Mee Bang ◽  
Sujung Kim ◽  
Jeong-Ok Lee ◽  
Yu Kim ◽  
...  

SummaryThis study was performed to determine the incidence, risk factors, and prognostic implications of venous thromboembolism (VTE) in Asian patients with colorectal cancer (CRC). Differences in clinical characteristics and prognostic impact between extremity venous thrombosis (or deep-vein thrombosis; DVT)/pulmonary embolism (PE) and intra-abdominal venous thrombosis (IVT) were also evaluated. For this study, consecutive CRC patients (N = 2,006) were enrolled and analyses were conducted retrospectively. VTEs were classified into two categories (DVT/PE and IVT). Significant predictors of developing VTEs were advanced stage and an increased number of co-morbidities. The two-year cumulative incidence of DVT/PE was 0.3%, 0.9% and 1.4% in stages 0~1, 2 and 3, respectively; this incidence range of DVT/PE in Asian patients with loco-regional CRC was lower than in Western patients. However, the two-year incidence (6.4%) of DVT/PE in Asian patients with distant metastases was not lower than in Western patients. Although 65.2% of patients with DVT/PE were symptomatic, only 15.7% of patients with IVT were symptomatic. During chemotherapy, DVT/PE developed more frequently than IVT. Only DVT/PE had a negative effect on survival; IVT had no prognostic significance. In conclusion, despite the low incidence of DVT/PE in Asian patients with loco-regional CRC, the protective effect of Asian ethnicity on VTE development disappears as tumour stage increases in patients with distant metastases. Considering different clinical characteristics and prognostic influences between DVT/PE and IVT, the treatment approach should be also different.


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