| Study name |
Role of heparin in the prevention of thromboembolism in patients with COVID‐19 and respiratory failure |
| Methods |
Prospective, multicentre, 2‐armed, parallel‐assignment RCT |
| Participants |
Number of participants: 652
Age: ≥ 18 years
Gender: female and male
Inclusion criteria
Confirmed or suspected COVID‐19 infection Endotracheal tube in place Intubated yesterday or today PaO2 to FIO2 ratio ≤ 300 while intubated Acute opacities on chest imaging affecting at least 1 lung quadrant
Exclusion criteria
Enrolled in another clinical study that is unapproved for co‐enrolment Heparin allergy or heparin‐induced thrombocytopenia aPTT > 120 s and not due to anticoagulant therapy Platelet count < 20 x 109/L Pulmonary bleeding Uncontrolled bleeding Obvious or suspected pregnancy Receiving or about to commence ECMO or HFOV Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently (e.g. Guillain‐Barré syndrome) Usually receives home oxygen Dependent on others for personal care due to physical or cognitive decline Death is imminent or inevitable within 24 h The clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification Clinician objection
|
| Interventions |
Intervention: parnaparin, dalteparin, nadroparin, bemiparin, reviparin, or enoxaparin
Control: standard LMWH prophylaxis |
| Outcomes |
Primary outcomes
To assess whether intermediate‐dose LMWH is more effective than standard LMWH prophylaxis in reducing the composite of all‐cause death or invasive mechanical ventilation or venous thromboembolic events. Time point of evaluation of this endpoint: 28 days To assess whether intermediate‐dose LMWH is more effective than standard LMWH prophylaxis in reducing venous thromboembolic events To assess the safety of intermediate‐dose LMWH in comparison to standard LMWH prophylaxis in incidence of major or clinically relevant non‐major bleedings
Secondary outcomes
Confirmed VTE within 28 days from randomisation Major or clinically relevant non‐major bleedings within 28 days from randomisation Confirmed VTE or persistent respiratory failure with need for oxygen therapy at 3 months from randomisation
|
| Starting date |
28 April 2021 |
| Contact information |
mariacristina.vedovati@unipg.it |
| Notes |
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