Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial) (IMPACT)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Anticoagulation
Eligibility Criteria
Inclusion Criteria:
- Age >18 years old
- COVID-19 positive on (RT-PCR) nasopharyngeal swab, or suspected COVID-19 infection with detectable SARS-CoV-2 IgG or IgM.
- Intensive care unit (ICU) patient or non-ICU patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula.
- D dimer level greater than 700 ng/mL (3 times the upper limit of normal).
Exclusion Criteria:
- Objectively documented deep vein thrombosis or pulmonary embolism
- Patients in whom there is very high suspicion for pulmonary embolism and are on full-dose anticoagulation as per the treating physician
- Platelets <30,000 not due to disseminated intravascular coagulation (DIC), based on the International Society of Thrombosis and Haemostasis (ISTH) criteria and American Society of Hematology (ASH) Frequently Asked Questions
- Active bleeding that poses a contraindication to therapeutic anticoagulation in the opinion of the investigator.
- History of bleeding diathesis (e.g., hemophilia, severe von Willebrand disease, severe thrombocytopathy)
- History of intracranial hemorrhage in the last 90 days
- History of ischemic stroke in the past 2 weeks
- Major neurosurgical procedure in the past 30 days
- Cardiothoracic surgery in the past 30 days
- Intra-abdominal surgery in the past 30 days
- Intracranial malignancy
- Patients who require therapeutic anticoagulation for other reasons like atrial fibrillation, deep venous thrombosis, pulmonary embolism, or antiphospholipid syndrome.
Sites / Locations
- New York Presbyterian Brooklyn Methodist Hospital
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Intermediate Dose Prophylaxis
Therapeutic Dose Anticoagulation
Subjects will receive one of the following interventions, at their physician's discretion: Enoxaparin 0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min Enoxaparin 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 mL/min If patient develops acute kidney injury: unfractionated heparin 7,500 units subcutaneously every 8 hours. Fondaparinux (if history of heparin-inducted thrombocytopenia [HIT]) 2.5 mg daily subcutaneously
Subjects will receive one of the following interventions, at their physician's discretion: Unfractionated heparin (UFH) to target anti-Xa level 0.3 -0.7 IU/mL or activated partial thromboplastin time (aPTT) (according to institutional protocol). Enoxaparin 1 mg/kg subcutaneously every 12 hours Argatroban (if heparin-induced thrombocytopenia [HIT]), dosed according to institutional protocol. Fondaparinux (if HIT and creatinine clearance greater than or equal to 50 ml/min) dosed by weight: ≥100 kg: 10 mg daily <100 kg but ≥50 kg: 7.5 mg daily <50 kg: 5 mg daily