The purpose of this study is to determine whether a higher dose of low molecular weight heparin (enoxaparin 40 mg b.i.d.) is superior than the standard prophylaxis dose (enoxaparin 40 mg o.d.) in reducing thromboembolic events in COVID-19 patients.
Coronavirus disease-19 (COVID-19 ), which is caused by SARS-CoV-2 infection, are apparently at high risk of venous thromboembolism (VTE), as a consequence of activation of the hemostatic system which, in the most severe cases, can also be associated with the formation of microthrombi and clinically relevant disseminated intravascular coagulation. Concerns about the efficacy of thromboprophylaxis with standard doses of low-molecular-weight heparin (LMWH) has been raised. Therefore, LMWH at higher doses than those recommended for thromboprophylaxis is used in some hospitals, although no evidence exists yet of higher efficacy of high doses compared to standard prophylactic doses. This practice might as well increase the risk of major bleeding. The investigators designed a randomized trial comparing standard prophylactic dose of subcutaneous enoxaparin (40 mg o.d.) with higher dose (40 mg b.i.d) with the aim of testing whether high-dose thromboprophylaxis is more effective than standard dose in preventing VTE in COVID-19 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
189
Subcutaneous enoxaparin
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy
Incidence of venous thromboembolism detected by imaging
Deep vein thrombosis events diagnosed by serial compression ultrasonography and pulmonary embolism events diagnosed by computed tomography scan
Time frame: 30 days
In hospital major complications
death, venous thromboembolism, use of mechanical ventilation, stroke, acute myocardial infarction and admission to an intensive care
Time frame: 30 days
Number of deep venous thrombosis events
Deep venous thrombosis events diagnosed by serial compression ultrasonography
Time frame: 30 days
Sequential organ failure assessment
Maximum sequential organ failure assessment (SOFA) score comparison between the two groups. The SOFA score ranges from 0 to 24. Higher SOFA score is associated with a greater risk of death or prolonged intensive care unit stay.
Time frame: 30 days
C-reactive protein
To compare C-reactive protein levels as % above the upper reference limit \[URL\]) among the two groups.
Time frame: 30 days
Interleukin-6
To compare Interleukin-6 levels as % above the upper reference limit \[URL\]) among the two groups.
Time frame: 30 days
D-dimer
To D-dimer compare levels as % above the upper reference limit \[URL\]) among the two groups.
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
hs-troponin levels
To compare hs-troponin levels as % above the upper reference limit \[URL\]) among the two groups.
Time frame: 30 days
Acute Respiratory Distress Syndrome
To compare the incidence of SARS-CoV-2-related Acute Respiratory Distress Syndrome (ARDS) between the two groups.
Time frame: 30 days
Hospital stay
To compare length of hospital stay between the two groups.
Time frame: 30 days
Right ventricular function
To compare measures of right ventricular function at trans-thoracic echocardiography or CT between admission and follow-up, whenever available
Time frame: 30 days
Number of pulmonary embolism events
Pulmonary embolism events diagnosed by computed tomography scan
Time frame: 30 days