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Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial) | Clinical Trials | Clareo Health

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

InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial)

NCT04406389•Weill Medical College of Cornell University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (2)

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

Weill Cornell Medicine

New York, New York, United States

Key Dates

Start Date

October 13, 2020

Primary Completion Date

April 17, 2021

Completion Date

April 21, 2022

Last Updated

September 21, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

Enoxaparin sodium

DRUG

Unfractionated heparin

DRUG

Fondapariniux

DRUG

Argatroban

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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