Status:
TERMINATED
Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 inte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04406389
Start Date
October 13 2020
End Date
April 21 2022
Last Update
September 21 2023
Active Locations (2)
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1
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
2
Weill Cornell Medicine
New York, New York, United States, 10065