Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)
Phase 4
Terminated
- Conditions
- COVID-19
- Interventions
- Registration Number
- NCT04406389
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
The purpose of this study is to determine if therapeutic dose anticoagulation (experimental group) improves 30-day mortality in participants with COVID-19 compared to those patients receiving the intermediate dose prophylaxis (control group). Following screening, subjects will be randomized 1:1 to intermediate dose prophylaxis or therapeutic dose anticoagulation treatment arms.Treatment will continue for 28 days, followed by a 6 month follow-up period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermediate Dose Prophylaxis Unfractionated heparin 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 Intermediate Dose Prophylaxis Fondapariniux 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 Therapeutic Dose Anticoagulation Fondapariniux 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 Therapeutic Dose Anticoagulation Argatroban 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 Intermediate Dose Prophylaxis Enoxaparin sodium 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 Therapeutic Dose Anticoagulation Unfractionated heparin 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 Therapeutic Dose Anticoagulation Enoxaparin sodium 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
- Primary Outcome Measures
Name Time Method 30-day Mortality 30 days Comparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm
- Secondary Outcome Measures
Name Time Method Number of Documented Venous Thromboembolism (VTE), Arterial Thrombosis (Stroke, Myocardial Infarction, Other) and Microthrombosis Events 6 months Comparison of number of documented VTE, arterial thrombosis and microthrombosis events on each treatment arm
Number of Major and Clinically Relevant Non-major Bleeding Events 6 months Comparison of major and clinically-relevant non-major bleeding events on each treatment arm, as defined by the International Society of Thrombosis and Haemostasis (ISTH) criteria.
Length of Intensive Care Unit (ICU) Stay in Days 6 months Comparison of length of ICU stay in days between each treatment arm.
Trial Locations
- Locations (2)
Weill Cornell Medicine
🇺🇸New York, New York, United States
New York Presbyterian Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States