Background: Current evidence points to a state of hypercoagulability (consequence of hyperinflammation) as an important pathogenic mechanism that contributes to the increase in mortality in cases of COVID-19. The aim of the present study was to investigate the influence of deep-vein thrombosis on mortality patient’s infected with SARS-CoV-2. Method: A clinical trial was conducted involving 200 consecutive patients with COVID-19—100 patients who were positive for deep-vein thrombosis (venous Doppler ultrasound) and 100 who were negative for deep-vein thrombosis at a public hospital. Results: The mortality rate was 67% in the group positive for DVT and 31% in the group negative for DVT. Conclusion: Deep-vein thrombosis is associated with an increase in mortality in patients with COVID-19 and failures can occur with conventional prophylaxis for deep-vein thrombosis.
Background Among the multiple complex pathophysiological mechanisms underlying Covid-19 pneumonia, immunothrombosis has been shown to play a key role. Objective The aim of the present study was to assess the monthly prevalence of deep venous thrombosis in a university hospital that admitted 5159 patients with Covid-19 in the medical ward and intensive care unit (ICU) and investigate whether there has been an increase in the prevalence of deep vein thrombosis and dead recently. Method A clinical trial was conducted evaluating 5159 patients admitted to the university hospital, Hospital de Base in São Jose do Rio Preto-Brazil, with a positive test for Covid-19, the prevalence of monthly deep venous thrombosis and the increase in thrombotic and events and mortality in March 2020 to April 2021 compared to the previous January and February with March–April of 2021. The evaluated by Fisher's exact test. Results The prevalence of deep vein thrombosis varied between the months of 0.26% to 7%, with an average of 2.5%. The months of March and April 2021 had a significant increase in venous thrombosis and mortality in relation to the months of January and February 2021. Conclusion The prevalence of deep venous thrombosis was variable during the months evaluated, since the beginning of Covid-19, but there was a significant increase in these last two months.
Several biosimilar versions of enoxaparin are already approved and in use globally. Analytical characterization can establish good quality control in manufacturing, but they may not assure similarity in clinical outcomes between biosimilar and branded enoxaparin. This study evaluated the efficacy and safety of biosimilar Cristália versus branded Sanofi enoxaparin in venous thromboembolism (VTE) prevention in patients undergoing major abdominal surgery at risk for VTE. In this randomized, prospective single-blind study, we compared Cristália enoxaparin (Ce), a biosimilar version, versus branded Sanofi enoxaparin (Se; at a dose of 40 mg subcutaneously per day postoperatively from 7 to 10 days) in 243 patients submitted to major abdominal surgery at risk for VTE for VTE prevention. The primary efficacy outcome was occurrence of VTE or death related to VTE. The principal safety outcomes were a combination of major bleeding and clinically relevant non-major bleeding. Bilateral duplex scanning of the legs was performed from days 10 to 14, and follow-ups were performed up to 60 days after surgery. The incidence of VTE was 4.9% in the Cristália group and 1.1% in the Sanofi group (absolute risk difference = 3.80%, 95% confidence interval [CI]: -1.4%-9.0%) yielding noninferiority since the 95% CI does not reach the prespecified value Δ = 20%. Clinically significant bleeding occurred in 9.9% in the Cristália group and in 5.5% in the Sanofi group (n.s. ). In conclusion, this study suggests that 40 mg once daily of Ce, a biosimilar enoxaparin, is as effective and safe as the branded Sanofi enoxaparin in the prophylaxis of VTE in patients submitted to major abdominal surgery at risk for VTE.
Background and objectiveThrombosis is one of the significant challenges associated with cardiovascular diseases and a prominent cause of death globally. This study aimed to determine the monthly and overall mortality rates by sex and age group in patients hospitalized with coronavirus disease 2019 (COVID-19) and the prevalence of deep vein thrombosis (DVT) in those patients. We also investigated whether the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) P.1 variant influenced DVT. MethodsWe determined the overall prevalence of COVID-19 per sex, age, and monthly mortality using hospital data at the São José do Rio Preto School of Medicine, state of São Paulo, Brazil. Data of COVID-19 patients with DVT as determined by echo-Doppler ultrasound (EDU) were analyzed by taking two time periods into account (prior to and after the onset of the predominance of the SARS-CoV-2 P.1 variant) to evaluate whether the viral variant exerted an influence on the prevalence of DVT. Patients with COVID-19 but without DVT comprised the control group. The first period was from March 2020 to February 2021, and the second was from March to June 2021. ResultsBetween March 2020 and June 2021, 6,199 patients were hospitalized with COVID-19 at our institution. Of these, 2,805 (45.25%) were women and 3,376 (54.47%) were men. Two hundred fifty-four were diagnosed with DVT based on lower limb EDU. The mean mortality rate was significantly associated with sex (38.36% for men and 27.16% for women; p=0.01). The incidence of DVT in patients with COVID-19 rose significantly from 1.6% during the first study period to 7.7% during the second study period (p=0.0001), when the P.1 variant became the predominant strain. The mortality rate was significantly higher in patients with COVID-19 and DVT (58.1%) compared to the control group (33.6%; p=0.0001). ConclusionBased on our findings, the incidence and prevalence of DVT increased with the predominance of P.1. viral variant. Early diagnosis and the reassessment of prophylaxis are the two most important factors to be addressed in this patient population.
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