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1.
Clin Appl Thromb Hemost ; 27: 10760296211051712, 2021.
Article in English | MEDLINE | ID: covidwho-1495925

ABSTRACT

BACKGROUND: Since the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pandemic, there have been many reports of increased incidence of venous thromboembolism and arterial events as a complication. OBJECTIVE: To determine the incidence of symptomatic thrombotic events (TEs) in patients hospitalized for SARS-CoV2 disease (coronavirus 19 [Covid-19]). METHODS: A retrospective single-center cohort study with adult patients with a positive reverse transcriptase-polymerase chain reaction (rt-PCR) for SARS-CoV2, included from the date of diagnosis of Covid-19 and followed for 90 days or until death. RESULTS: A total of 1621 patients were included in this study. The median age was 73 years (interquartile range25th-75th [IQR] 53-87 years) and 57% (913) were female. Overall mortality was 21.6% (348). The overall incidence of symptomatic TEs within 90 days of diagnosis was 1.8% (30 of 1621) occurring in 28 patients, including an incidence of pulmonary embolism of 0.9% (15, 95% confidence interval [CI] 0.60%-1.6%), deep venous thrombosis of 0.61% (10, 95% CI 0.2%-1%), ischemic stroke of 0.25% (4, 95% CI 0.09%-0.65%), and ischemic arterial events of 0.06% (1, 95% CI 0.008%-0.43%). No acute coronary syndrome events were recorded. The incidence of symptomatic TEs was significantly lower in the general ward than in intensive care units (1.2% vs 5.7%; p < .001). The median time since positive rt-PCR for SARS-CoV2 to symptomatic TE was 22.5 days (IQR 19-43 days). There was no significant difference in the proportion of patients receiving (53.6%) and not receiving thromboprophylaxis (66.5%) and the development of TEs. CONCLUSION: The overall incidence of symptomatic TEs among these patients was lower than the incidence previously reported.


Subject(s)
Arterial Occlusive Diseases/epidemiology , COVID-19/epidemiology , Pulmonary Embolism/epidemiology , Thromboembolism/epidemiology , Venous Thrombosis/epidemiology , Aged , Aged, 80 and over , Argentina/epidemiology , Arterial Occlusive Diseases/blood , Arterial Occlusive Diseases/diagnosis , COVID-19/blood , COVID-19/diagnosis , Female , Humans , Incidence , Ischemic Stroke/blood , Ischemic Stroke/diagnosis , Ischemic Stroke/epidemiology , Male , Middle Aged , Patient Admission , Pulmonary Embolism/blood , Pulmonary Embolism/diagnosis , Retrospective Studies , Thromboembolism/blood , Thromboembolism/diagnosis , Time Factors , Venous Thrombosis/blood , Venous Thrombosis/diagnosis
3.
Mayo Clin Proc ; 96(10): 2587-2597, 2021 10.
Article in English | MEDLINE | ID: covidwho-1450188

ABSTRACT

OBJECTIVE: To assess the associations between coronavirus disease 2019 (COVID-19) infection and thromboembolism including myocardial infarction (MI), ischemic stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE). PATIENTS AND METHODS: A self-controlled case-series study was conducted covering the whole of Scotland's general population. The study population comprised individuals with confirmed (positive test) COVID-19 and at least one thromboembolic event between March 2018 and October 2020. Their incidence rates during the risk interval (5 days before to 56 days after the positive test) and the control interval (the remaining periods) were compared intrapersonally. RESULTS: Across Scotland, 1449 individuals tested positive for COVID-19 and experienced a thromboembolic event. The risk of thromboembolism was significantly elevated over the whole risk period but highest in the 7 days following the positive test (incidence rate ratio, 12.01; 95% CI, 9.91 to 14.56) in all included individuals. The association was also present in individuals not originally hospitalized for COVID-19 (incidence rate ratio, 4.07; 95% CI, 2.83 to 5.85). Risk of MI, stroke, PE, and DVT were all significantly higher in the week following a positive test. The risk of PE and DVT was particularly high and remained significantly elevated even 56 days following the test. CONCLUSION: Confirmed COVID-19 infection was associated with early elevations in risk with MI, ischemic stroke, and substantially stronger and prolonged elevations with DVT and PE both in hospital and community settings. Clinicians should consider thromboembolism, especially PE, among people with COVID-19 in the community.


Subject(s)
COVID-19/complications , Pulmonary Embolism/etiology , Thromboembolism/etiology , Aged , COVID-19/diagnosis , Case-Control Studies , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Pulmonary Embolism/diagnosis , Risk Factors , Scotland , Thromboembolism/diagnosis
4.
Europace ; 23(6): 937-947, 2021 06 07.
Article in English | MEDLINE | ID: covidwho-1411958

ABSTRACT

AIMS: Age, sex, and cardiovascular disease have been linked to thromboembolic complications and poorer outcomes in COVID-19. We hypothesize that CHADS2 and CHA2DS2-VASc scores may predict thromboembolic events and mortality in COVID-19. METHODS AND RESULTS: COVID-19 hospitalized patients with confirmed SARS-CoV-2 infection from 1 March to 20 April 2020 who completed at least 1-month follow-up or died were studied. CHADS2 and CHA2DS2-VASc scores were calculated. Given the worse prognosis of male patients in COVID-19, a modified CHA2DS2-VASc score (CHA2DS2-VASc-M) in which 1 point was given to male instead of female was also calculated. The associations of these scores with laboratory results, thromboembolic events, and death were analysed. A total of 3042 patients (mean age 62.3 ± 20.3 years, 54.9% male) were studied and 115 (3.8%) and 626 (20.6%) presented a definite thromboembolic event or died, respectively, during the study period [median follow 59 (50-66) days]. Higher score values were associated with more marked abnormalities of inflammatory and cardiac biomarkers. Mortality was significantly higher with increasing scores for CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-M (P < 0.001 for trend). The CHA2DS2-VASc-M showed the best predictive value for mortality [area under the receiver operating characteristic curve (AUC) 0.820, P < 0.001 for comparisons]. All scores had poor predictive value for thromboembolic events (AUC 0.497, 0.490, and 0.541, respectively). CONCLUSION: The CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-M scores are significantly associated with all-cause mortality but not with thromboembolism in COVID-19 patients. They are simple scoring systems in everyday use that may facilitate initial 'quick' prognostic stratification in COVID-19.


Subject(s)
Atrial Fibrillation , COVID-19 , Stroke , Thromboembolism , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Risk Assessment , Risk Factors , SARS-CoV-2 , Thromboembolism/diagnosis , Thromboembolism/epidemiology
5.
Postgrad Med ; 133(8): 899-911, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1390265

ABSTRACT

INTRODUCTION: COVID-19-associated coagulopathy (CAC) is a well-recognized hematologic complication among patients with severe COVID-19 disease, where macro- and micro-thrombosis can lead to multiorgan injury and failure. Major societal guidelines that have published on the management of CAC are based on consensus of expert opinion, with the current evidence available. As a result of limited studies, there are many clinical scenarios that are yet to be addressed, with expert opinion varying on a number of important clinical issues regarding CAC management. METHODS: In this review, we utilize current societal guidelines to provide a framework for practitioners in managing their patients with CAC. We have also provided three clinical scenarios that implement important principles of anticoagulation in patients with COVID-19. CONCLUSION: Overall, decisions should be made on acase by cases basis and based on the providers understanding of each patient's medical history, clinical course and perceived risk.


Subject(s)
Anticoagulants/therapeutic use , Blood Coagulation Disorders/therapy , COVID-19/complications , Practice Guidelines as Topic , Thromboembolism/therapy , Thrombosis/therapy , Anticoagulants/adverse effects , Biomarkers/blood , Blood Coagulation Disorders/diagnosis , Blood Coagulation Disorders/virology , Drug Monitoring , Fibrinolytic Agents/therapeutic use , Hemorrhage/chemically induced , Hemorrhage/therapy , Heparin/therapeutic use , Humans , Prevalence , Thromboembolism/diagnosis , Thromboembolism/epidemiology , Thromboembolism/virology , Thrombosis/diagnosis , Thrombosis/epidemiology , Thrombosis/virology
6.
Metabolism ; 123: 154845, 2021 10.
Article in English | MEDLINE | ID: covidwho-1340768

ABSTRACT

PURPOSE: Individuals with diabetes/stress hyperglycemia carry an increased risk for adverse clinical outcome in case of SARS-CoV-2 infection. The purpose of this study was to evaluate whether this risk is, at least in part, modulated by an increase of thromboembolic complications. METHODS: We prospectively followed 180 hospitalized patients with confirmed COVID-19 pneumonia admitted to the Internal Medicine Units of San Raffaele Hospital. Data from 11 out of 180 patients were considered incomplete and excluded from the analysis. We analysed inflammation, tissue damage biomarkers, hemostatic parameters, thrombotic events (TEs) and clinical outcome according to the presence of diabetes/stress hyperglycemia. RESULTS: Among 169 patients, 51 (30.2%) had diabetes/stress hyperglycemia. Diabetes/stress hyperglycemia and fasting blood glucose (FBG) were associated with increased inflammation and tissue damage circulating markers, higher D-dimer levels, increased prothrombin time and lower antithrombin III activity. Forty-eight venous and 10 arterial TEs were identified in 49 (29%) patients. Diabetes/stress hyperglycemia (HR 2.71, p = 0.001), fasting blood glucose (HR 4.32, p < 0.001) and glucose variability (HR 1.6, p < 0.009) were all associated with an increased risk of thromboembolic complication. TEs significantly increased the risk for an adverse clinical outcome only in the presence of diabetes/stress hyperglycemia (HR 3.05, p = 0.010) or fasting blood glucose ≥7 mmol/L (HR 3.07, p = 0.015). CONCLUSIONS: Thromboembolism risk is higher among patients with diabetes/stress hyperglycemia and COVID-19 pneumonia and is associated to poor clinical outcome. In case of SARS-Cov-2 infection patients with diabetes/stress hyperglycemia could be considered for a more intensive prophylactic anticoagulation regimen.


Subject(s)
COVID-19/epidemiology , Diabetes Mellitus/epidemiology , Hyperglycemia/epidemiology , Thromboembolism/etiology , Aged , Aged, 80 and over , COVID-19/complications , COVID-19/diagnosis , COVID-19/therapy , Diabetes Complications/diagnosis , Diabetes Complications/epidemiology , Diabetes Complications/therapy , Diabetes Mellitus/blood , Diabetes Mellitus/diagnosis , Diabetes Mellitus/therapy , Female , Follow-Up Studies , Hospitalization/statistics & numerical data , Humans , Hyperglycemia/diagnosis , Hyperglycemia/etiology , Hyperglycemia/therapy , Inflammation/complications , Inflammation/diagnosis , Inflammation/epidemiology , Inflammation/therapy , Italy/epidemiology , Male , Middle Aged , Mortality , Prognosis , Risk Factors , Stress, Psychological/complications , Stress, Psychological/diagnosis , Stress, Psychological/epidemiology , Thromboembolism/diagnosis , Thromboembolism/epidemiology , Treatment Outcome
7.
Expert Opin Drug Saf ; 20(11): 1451-1453, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1310857

ABSTRACT

Introduction: Concerns about the increased risk of blood clots associated with the VAXZEVRIA (previously named Oxford-AstraZeneca COVID-19 vaccine) and Johnson & Johnson (Janssen) COVID-19 vaccines raises the question of the thrombotic safety of other COVID-19 vaccines such as Pfizer-BioNTech or Moderna, especially in younger women, who at the early stage of the pandemic was a priority group for vaccination. Methods: Using the US-based Vaccine Adverse Event Reporting System (VAERS) and the FDA Event Reporting System (FAERS), we retrieved cases of thrombosis following vaccinations or hormonal contraceptive use in women aged ≤ 50 years. We used the reporting odds ratio (ROR) as a disproportionality measure. Results: On 19 March 2021, out of 13.6 million women aged ≤ 50 exposed to at least one dose of Pfizer-BioNTech or Moderna COVID-19 vaccines in the US, only 61 cases were reported with a total of 68 thromboembolic events (1 case per 222,951 vaccinated). None of the thromboembolic events included in our analysis were disproportionally reported for the two COVID-19 vaccines. Conclusion: Our results do support that, when compared to hormonal contraceptive use, the mRNA vaccines do not show disproportional reporting of thromboembolic events in younger women.


Subject(s)
COVID-19 Vaccines/adverse effects , Thromboembolism/blood , Vaccination/adverse effects , Adverse Drug Reaction Reporting Systems , Age Factors , COVID-19 Vaccines/administration & dosage , Contraceptives, Oral, Hormonal/adverse effects , Female , Hormonal Contraception/adverse effects , Humans , Middle Aged , Risk Assessment , Risk Factors , Sex Factors , Thromboembolism/diagnosis , Thromboembolism/epidemiology , Treatment Outcome
8.
Jt Dis Relat Surg ; 32(2): 551-555, 2021.
Article in English | MEDLINE | ID: covidwho-1279005

ABSTRACT

Although novel coronavirus-2019 (COVID-19) primarily affects the respiratory system, it can affect multiple organ systems, leading to serious complications, such as acute respiratory distress syndrome (ARDS) and multiple organ failure. Nearly 20 to 55% of patients with COVID-19 experience coagulation disorders that cause high mortality in line with the severity of the clinical picture. Thromboembolism can be observed in both venous and arterial systems. The vast majority of thromboembolic events are associated with the venous system and are often observed as pulmonary embolism. Arterial thromboembolisms often involve the arteries in the lower extremities, followed by those in the upper extremities. Herein, we report a rare case of COVID-19 pneumonia whose left arm was amputated at the forearm level after arterial thromboembolism in the left upper extremity. This case report is valuable, as it is the first reported case of upper extremity arterial thromboembolism in Turkey, as well as the only case in the literature in which the patient underwent four surgical interventions and is still alive.


Subject(s)
Amputation/methods , Brachial Artery , COVID-19 , Reoperation/methods , Thrombectomy , Thromboembolism , Upper Extremity , Aged , Brachial Artery/diagnostic imaging , Brachial Artery/pathology , COVID-19/blood , COVID-19/complications , COVID-19/diagnosis , COVID-19/therapy , Computed Tomography Angiography/methods , Humans , Male , Recurrence , SARS-CoV-2/isolation & purification , Severity of Illness Index , Thrombectomy/adverse effects , Thrombectomy/methods , Thromboembolism/complications , Thromboembolism/diagnosis , Thromboembolism/etiology , Treatment Outcome , Upper Extremity/blood supply , Upper Extremity/pathology , Upper Extremity/surgery
10.
AJNR Am J Neuroradiol ; 42(7): 1196-1200, 2021 07.
Article in English | MEDLINE | ID: covidwho-1200067

ABSTRACT

BACKGROUND AND PURPOSE: Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) infection is associated with hypercoagulability. We sought to evaluate the demographic and clinical characteristics of cerebral venous thrombosis among patients hospitalized for coronavirus disease 2019 (COVID-19) at 6 tertiary care centers in the New York City metropolitan area. MATERIALS AND METHODS: We conducted a retrospective multicenter cohort study of 13,500 consecutive patients with COVID-19 who were hospitalized between March 1 and May 30, 2020. RESULTS: Of 13,500 patients with COVID-19, twelve had imaging-proved cerebral venous thrombosis with an incidence of 8.8 per 10,000 during 3 months, which is considerably higher than the reported incidence of cerebral venous thrombosis in the general population of 5 per million annually. There was a male preponderance (8 men, 4 women) and an average age of 49 years (95% CI, 36-62 years; range, 17-95 years). Only 1 patient (8%) had a history of thromboembolic disease. Neurologic symptoms secondary to cerebral venous thrombosis occurred within 24 hours of the onset of the respiratory and constitutional symptoms in 58% of cases, and 75% had venous infarction, hemorrhage, or both on brain imaging. Management consisted of anticoagulation, endovascular thrombectomy, and surgical hematoma evacuation. The mortality rate was 25%. CONCLUSIONS: Early evidence suggests a higher-than-expected frequency of cerebral venous thrombosis among patients hospitalized for COVID-19. Cerebral venous thrombosis should be included in the differential diagnosis of neurologic syndromes associated with SARS-CoV-2 infection.


Subject(s)
COVID-19/epidemiology , Intracranial Thrombosis/epidemiology , Thromboembolism/epidemiology , Adult , COVID-19/diagnosis , Causality , Cohort Studies , Comorbidity , Female , Humans , Intracranial Thrombosis/diagnosis , Male , Middle Aged , New York City/epidemiology , Retrospective Studies , Risk Factors , Thrombectomy/adverse effects , Thromboembolism/diagnosis , Venous Thrombosis/epidemiology
11.
Pan Afr Med J ; 38: 275, 2021.
Article in English | MEDLINE | ID: covidwho-1190642

ABSTRACT

Since the spread of the coronavirus disease 2019 (COVID-19) pandemic, cardiovascular complications are interestingly increasing, particularly thrombotic events, especially in those requiring intensive care. Venous thromboembolism is well known to occur in patients infected by the SARS-CoV-2, but only a few arterial thromboembolism cases have been previously reported. Herein, we report the case of a COVID-19 complicated by a concomitant acute right limb ischemia and multiple acute ischemic strokes. This rare case emphasizes the hypercoagulable state described in COVID-19 patients and the need for anticoagulation therapy to prevent these severe complications.


Subject(s)
COVID-19/complications , Ischemia/diagnosis , Ischemic Stroke/diagnosis , Thromboembolism/diagnosis , Acute Disease , Aged , Humans , Ischemia/virology , Ischemic Stroke/virology , Male , Thromboembolism/virology
12.
Thorac Cardiovasc Surg ; 69(6): 526-536, 2021 09.
Article in English | MEDLINE | ID: covidwho-1189327

ABSTRACT

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is a potential treatment option in critically ill COVID-19 patients suffering from acute respiratory distress syndrome (ARDS) if mechanical ventilation (MV) is insufficient; however, thromboembolic and bleeding events (TEBE) during ECMO treatment still need to be investigated. METHODS: We conducted a retrospective, single-center study including COVID-19 patients treated with ECMO. Additionally, we performed a univariate analysis of 85 pre-ECMO variables to identify factors influencing incidences of thromboembolic events (TEE) and bleeding events (BE), respectively. RESULTS: Seventeen patients were included; the median age was 57 years (interquartile range [IQR]: 51.5-62), 11 patients were males (65%), median ECMO duration was 16 days (IQR: 10.5-22), and the overall survival was 53%. Twelve patients (71%) developed TEBE. We observed 7 patients (41%) who developed TEE and 10 patients (59%) with BE. Upper respiratory tract (URT) bleeding was the most frequent BE with eight cases (47%). Regarding TEE, pulmonary artery embolism (PAE) had the highest incidence with five cases (29%). The comparison of diverse pre-ECMO variables between patients with and without TEBE detected one statistically significant value. The platelet count was significantly lower in the BE group (n = 10) than in the non-BE group (n = 7) with 209 (IQR: 145-238) versus 452 G/L (IQR: 240-560), with p = 0.007. CONCLUSION: This study describes the incidences of TEE and BE in critically ill COVID-19 patients treated with ECMO. The most common adverse event during ECMO support was bleeding, which occurred at a comparable rate to non-COVID-19 patients treated with ECMO.


Subject(s)
COVID-19/therapy , Extracorporeal Membrane Oxygenation/adverse effects , Hemorrhage/epidemiology , Thromboembolism/epidemiology , Aged , COVID-19/diagnosis , COVID-19/epidemiology , Critical Illness , Female , Germany/epidemiology , Hemorrhage/diagnosis , Humans , Incidence , Male , Middle Aged , Retrospective Studies , Risk Assessment , Risk Factors , Thromboembolism/diagnosis , Treatment Outcome
13.
Turk Kardiyol Dern Ars ; 49(3): 233-236, 2021 04.
Article in English | MEDLINE | ID: covidwho-1181749

ABSTRACT

As the COVID-19 pandemic continues, its novel complications are being increasingly recognized, and new mechanisms of the disease are being unraveled. Aortic free-floating thrombus is exceptionally rare, and prompt diagnosis is vital to alleviate its detrimental end organ effects. We present a patient who was previously discharged owing to COVID-19 pneumonia, admitted with acute onset of lower limb pain, and was diagnosed with aortic free-floating thrombus ended up with embolic events. Clinicians should be aware of COVID-19-related thromboembolic complications, and close monitoring of patients with risk factors is vital for a timely and accurate diagnosis and management.


Subject(s)
COVID-19/complications , Infarction/etiology , Ischemia/etiology , Kidney/blood supply , Lower Extremity/blood supply , Thromboembolism/etiology , Aortic Diseases/diagnosis , Aortic Diseases/etiology , Humans , Infarction/diagnosis , Ischemia/diagnosis , Male , Middle Aged , SARS-CoV-2 , Thromboembolism/diagnosis , Thrombosis/diagnosis , Thrombosis/etiology
14.
J Thromb Thrombolysis ; 52(3): 772-778, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1176387

ABSTRACT

It is still debated whether prophylactic doses of low-molecular- weight heparin (LMWH) are always effective in preventing Venous Thromboembolism (VTE) and mortality in COVID-19. Furthermore, there is paucity of data for those patients not requiring ventilation. We explored mortality and the safety/efficacy profile of LMWH in a cohort of Italian patients with COVID-19 who did not undergo ventilation. From the initial cohort of 422 patients, 264 were enrolled. Most (n = 156, 87.7%) received standard LMWH prophylaxis during hospitalization, with no significant difference between medical wards and Intensive Care Unit (ICU). Major or not major but clinically relevant hemorrhages were recorded in 13 (4.9%) patients: twelve in those taking prophylactic LMWH and one in a patient taking oral anticoagulants (p: n.s.). Thirty-nine patients (14.8%) with median age 75 years. were transfused. Hemoglobin (Hb) at admission was significantly lower in transfused patients and Hb at admission inversely correlated with the number of red blood cells units transfused (p < 0.001). In-hospital mortality occurred in 76 (28.8%) patients, 46 (24.3%) of whom admitted to medical wards. Furthermore, Hb levels at admittance were significantly lower in fatalities (g/dl 12.3; IQR 2.4 vs. 13.3; IQR 2.8; Mann-Whitney U-test; p = 0.001). After the exclusion of patients treated by LMWH intermediate or therapeutic doses (n = 32), the logistic regression showed that prophylaxis significantly and independently reduced mortality (OR 0.31, 95% CI 0.13-0.85). Present data show that COVID-19 patients who do not require ventilation benefit from prophylactic doses of LMWH.


Subject(s)
Anticoagulants/therapeutic use , Blood Transfusion , COVID-19/therapy , Heparin, Low-Molecular-Weight/therapeutic use , Thromboembolism/prevention & control , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Blood Transfusion/mortality , COVID-19/blood , COVID-19/diagnosis , COVID-19/mortality , Clinical Decision-Making , Female , Heparin, Low-Molecular-Weight/adverse effects , Hospital Mortality , Hospitalization , Humans , Male , Middle Aged , Protective Factors , Risk Assessment , Risk Factors , Thromboembolism/blood , Thromboembolism/diagnosis , Thromboembolism/mortality , Time Factors , Treatment Outcome
15.
Thromb Haemost ; 121(12): 1684-1695, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1171416

ABSTRACT

Coronavirus disease-2019 (COVID-19) has been associated with significant risk of venous thromboembolism (VTE), arterial thromboembolism (ATE), and mortality particularly among hospitalized patients with critical illness and elevated D-dimer (Dd) levels. Conflicting data have yet to elucidate optimal thromboprophylaxis dosing. HEP-COVID (NCT04401293) is a phase 3, multicenter, pragmatic, prospective, randomized, pseudo-blinded, active control trial to evaluate efficacy and safety of therapeutic-dose low-molecular-weight heparin (LMWH) versus prophylactic-/intermediate-dose LMWH or unfractionated heparin (UFH) for prevention of a primary efficacy composite outcome of VTE, ATE, and all-cause mortality 30 ± 2 days post-enrollment. Eligible patients have COVID-19 diagnosis by nasal swab or serologic testing, requirement for supplemental oxygen per investigator judgment, and Dd >4 × upper limit of normal (ULN) or sepsis-induced coagulopathy score ≥4. Subjects are randomized to enoxaparin 1 mg/kg subcutaneous (SQ)/two times a day (BID) (creatinine clearance [CrCl] ≥ 30 mL/min) or 0.5 mg/kg (CrCl 15-30 mL/min) versus local institutional prophylactic regimens including (1) UFH up to 22,500 IU (international unit) daily (divided BID or three times a day), (2) enoxaparin 30 and 40 mg SQ QD (once daily) or BID, or (3) dalteparin 2,500 IU or 5,000 IU QD. The principal safety outcome is major bleeding. Events are adjudicated locally. Based on expected 40% relative risk reduction with treatment-dose compared with prophylactic-dose prophylaxis, 308 subjects will be enrolled (assuming 20% drop-out) to achieve 80% power. Distinguishing design features include an enriched population for the composite endpoint anchored on Dd >4 × ULN, stratification by intensive care unit (ICU) versus non-ICU, and the ability to capture asymptomatic proximal deep venous thrombosis via screening ultrasonography prior to discharge.


Subject(s)
Anticoagulants/administration & dosage , COVID-19/drug therapy , Enoxaparin/administration & dosage , Thromboembolism/drug therapy , Anticoagulants/adverse effects , COVID-19/complications , COVID-19/diagnosis , Clinical Trials, Phase III as Topic , Enoxaparin/adverse effects , Humans , Pragmatic Clinical Trials as Topic , Prospective Studies , Risk Assessment , Risk Factors , Thromboembolism/diagnosis , Thromboembolism/etiology , Time Factors , Treatment Outcome , United States , Venous Thromboembolism/diagnosis , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control
17.
J Thromb Thrombolysis ; 52(3): 914-924, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1137164

ABSTRACT

In this study, we investigated whether the CHA2DS2-VASc score could be used to estimate the need for hospitalization in the intensive care unit (ICU), the length of stay in the ICU, and mortality in patients with COVID-19. Patients admitted to Merkezefendi State Hospital because of COVID-19 diagnosis confirmed by RNA detection of virus by using polymerase chain reaction between March 24, 2020 and July 6, 2020, were screened retrospectively. The CHA2DS2-VASc and modified CHA2DS2-VASc score of all patients was calculated. Also, we received all patients' complete biochemical markers including D-dimer, Troponin I, and c-reactive protein on admission. We enrolled 1000 patients; 791 were admitted to the general medical service and 209 to the ICU; 82 of these 209 patients died. The ROC curves of the CHA2DS2-VASc and M-CHA2DS2-VASc scores were analyzed. The cut-off values of these scores for predicting mortality were ≥ 3 (2 or under and 3). The CHA2DS2-VASc and M-CHA2DS2-VASc scores had an area under the curve value of 0.89 on the ROC. The sensitivity and specificity of the CHA2DS2-VASc scores were 81.7% and 83.8%, respectively; the sensitivity and specificity of the M-CHA2DS2-VASc scores were 85.3% and 84.1%, respectively. Multivariate logistic regression analysis showed that CHA2DS2-VASc, Troponin I, D-Dimer, and CRP were independent predictors of mortality in COVID-19 patients. Using a simple and easily available scoring system, CHA2DS2-VASc and M-CHA2DS2-VASc scores can be assessed in patients diagnosed with COVID-19. These scores can predict mortality and the need for ICU hospitalization in these patients.


Subject(s)
COVID-19/diagnosis , Decision Support Techniques , Hospital Mortality , Hospitalization , Intensive Care Units , Thromboembolism/diagnosis , Adolescent , Adult , Aged , Biomarkers/blood , COVID-19/blood , COVID-19/mortality , COVID-19/therapy , Female , Fibrin Fibrinogen Degradation Products/analysis , Humans , Length of Stay , Male , Middle Aged , Predictive Value of Tests , Prognosis , Receptors, Immunologic/analysis , Retrospective Studies , Risk Assessment , Risk Factors , Thromboembolism/blood , Thromboembolism/mortality , Thromboembolism/therapy , Time Factors , Troponin I/blood , Turkey , Young Adult
18.
Pharmacol Res ; 167: 105534, 2021 05.
Article in English | MEDLINE | ID: covidwho-1117457

ABSTRACT

BACKGROUND: Antipsychotic medications are frequently prescribed to people with dementia to manage behavioural and psychological symptoms. Using a global federated research network, the objectives were to determine: 1) if COVID-19 is associated with 30-day thromboembolic events and mortality for people with dementia receiving antipsychotic medications; and 2) if the proportion of people with dementia receiving antipsychotics is higher during the COVID-19 pandemic compared to 2019. METHODS: A retrospective cohort study was conducted using TriNetX, a global federated health research network. The network was searched for people aged ≥ 65 years with dementia, COVID-19 and use of antipsychotics in the 30-days prior to COVID-19 recorded in electronic medical records between 20/01/2020 and 05/12/2020. These individuals were compared to historical controls from 2019 with dementia and use of antipsychotics in the 30-days before a visit to a participating healthcare organisation. Propensity score matching for age, sex, race, co-morbidities and use of antidepressants and anticonvulsants was used to balance cohorts with and without COVID-19. RESULTS: Within the TriNetX network, 8414 individuals with COVID-19, dementia and use of antipsychotics and 31,963 historical controls were identified. After propensity score matching there were 8396 individuals with COVID-19 and 8396 historical controls. The cohorts were well balanced for age, sex, race, co-morbidities and use of antidepressants and anticonvulsants. The odds of 30-day thromboembolic events and all-cause mortality were significantly higher in adults with COVID-19 (Odds Ratios: 1.36 (95% confidence interval (CI): 1.21-1.52) and 1.93 (1.71-2.17), respectively). The number of people with dementia with a visit to a participating healthcare organisation was lower between 20/01/2020 and 05/12/2020 (n = 165,447) compared to the same period in 2019 (n = 217,391), but the proportion receiving antipsychotics increased from 14.7% (95%CI: 14.6-14.9%) to 16.4% (95%CI: 16.2-16.5%), P < .0001. CONCLUSIONS: These findings add to the evidence base that during the COVID-19 pandemic there was an increase in the proportion of people with dementia receiving antipsychotics. The negative effects of antipsychotics in patients with dementia may be compounded by concomitant COVID-19.


Subject(s)
Antipsychotic Agents/adverse effects , COVID-19/epidemiology , Dementia/drug therapy , Thromboembolism/epidemiology , Aged , Aged, 80 and over , COVID-19/diagnosis , COVID-19/mortality , Dementia/diagnosis , Dementia/mortality , Dementia/psychology , Electronic Health Records , Female , Humans , Male , Prognosis , Retrospective Studies , Risk Assessment , Risk Factors , Thromboembolism/diagnosis , Thromboembolism/mortality , Time Factors
19.
J Thromb Thrombolysis ; 52(3): 782-790, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1111318

ABSTRACT

A pro-thrombotic milieu and a higher risk of thrombotic events were observed in patients with CoronaVirus disease-19 (COVID-19). Accordingly, recent data suggested a beneficial role of low molecular weight heparin (LMWH), but the optimal dosage of this treatment is unknown. We evaluated the association between prophylactic vs. intermediate-to-fully anticoagulant doses of enoxaparin and in-hospital adverse events in patients with COVID-19. We retrospectively included 436 consecutive patients admitted in three Italian hospitals. Outcome according to the use of prophylactic (4000 IU) vs. higher (> 4000 IU) daily dosage of enoxaparin was evaluated. The primary end-point was in-hospital death. Secondary outcome measures were in-hospital cardiovascular death, venous thromboembolism, new-onset acute respiratory distress syndrome (ARDS) and mechanical ventilation. A total of 287 patients (65.8%) were treated with the prophylactic enoxaparin regimen and 149 (34.2%) with a higher dosing regimen. The use of prophylactic enoxaparin dose was associated with a similar incidence of all-cause mortality (25.4% vs. 26.9% with the higher dose; OR at multivariable analysis, including the propensity score: 0.847, 95% CI 0.400-0.1.792; p = 0.664). In the prophylactic dose group, a significantly lower incidence of cardiovascular death (OR 0.165), venous thromboembolism (OR 0.067), new-onset ARDS (OR 0.454) and mechanical intubation (OR 0.150) was observed. In patients hospitalized for COVID-19, the use of a prophylactic dosage of enoxaparin appears to be associated with similar in-hospital overall mortality compared to higher doses. These findings require confirmation in a randomized, controlled study.


Subject(s)
Anticoagulants/administration & dosage , COVID-19/therapy , Enoxaparin/administration & dosage , Hospitalization , Thromboembolism/prevention & control , Aged , Aged, 80 and over , Anticoagulants/adverse effects , COVID-19/blood , COVID-19/diagnosis , COVID-19/mortality , Enoxaparin/adverse effects , Female , Hospital Mortality , Humans , Italy , Male , Middle Aged , Protective Factors , Respiration, Artificial , Retrospective Studies , Risk Assessment , Risk Factors , Thromboembolism/blood , Thromboembolism/diagnosis , Thromboembolism/mortality , Time Factors , Treatment Outcome
20.
Thorax ; 76(10): 970-979, 2021 10.
Article in English | MEDLINE | ID: covidwho-1099791

ABSTRACT

BACKGROUND: The prevalence of venous thromboembolic event (VTE) and arterial thromboembolic event (ATE) thromboembolic events in patients with COVID-19 remains largely unknown. METHODS: In this meta-analysis, we systematically searched for observational studies describing the prevalence of VTE and ATE in COVID-19 up to 30 September 2020. RESULTS: We analysed findings from 102 studies (64 503 patients). The frequency of COVID-19-related VTE was 14.7% (95% CI 12.1% to 17.6%, I2=94%; 56 studies; 16 507 patients). The overall prevalence rates of pulmonary embolism (PE) and leg deep vein thrombosis were 7.8% (95% CI 6.2% to 9.4%, I2=94%; 66 studies; 23 117 patients) and 11.2% (95% CI 8.4% to 14.3%, I2=95%; 48 studies; 13 824 patients), respectively. Few were isolated subsegmental PE. The VTE prevalence was significantly higher in intensive care unit (ICU) (23.2%, 95% CI 17.5% to 29.6%, I2=92%, vs 9.0%, 95% CI 6.9% to 11.4%, I2=95%; pinteraction<0.0001) and in series systematically screening patients compared with series testing symptomatic patients (25.2% vs 12.7%, pinteraction=0.04). The frequency rates of overall ATE, acute coronary syndrome, stroke and other ATE were 3.9% (95% CI 2.0% to to 3.0%, I2=96%; 16 studies; 7939 patients), 1.6% (95% CI 1.0% to 2.2%, I2=93%; 27 studies; 40 597 patients) and 0.9% (95% CI 0.5% to 1.5%, I2=84%; 17 studies; 20 139 patients), respectively. Metaregression and subgroup analyses failed to explain heterogeneity of overall ATE. High heterogeneity limited the value of estimates. CONCLUSIONS: Patients admitted in the ICU for severe COVID-19 had a high risk of VTE. Conversely, further studies are needed to determine the specific effects of COVID-19 on the risk of ATE or VTE in less severe forms of the disease.


Subject(s)
COVID-19/complications , Thromboembolism/epidemiology , COVID-19/diagnosis , COVID-19/therapy , Critical Care , Hospitalization , Humans , Prevalence , Thromboembolism/diagnosis , Thromboembolism/prevention & control
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