Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Argatroban; Calcium heparin; Enoxaparin; Enoxaparin sodium; Heparin

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.