Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial) (NCT04406389) | Clinical Trial Compass
TerminatedPhase 4
Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)
Stopped: Low accrual
United States14 participantsStarted 2020-10-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 fibrillatio…
What they're measuring
1
30-day Mortality
Timeframe: 30 days
Trial details
NCT IDNCT04406389
SponsorWeill Medical College of Cornell University