Status:
COMPLETED
Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC)
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
University Health Network, Toronto
Conditions:
COVID-19
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Endothelial injury as a consequence of SARS-CoV-2 infection leads to a dysregulated host inflammatory response and activation of coagulation pathways. Macro- and micro-vascular thrombosis may contribu...
Detailed Description
This is a prospective, open-label, multicentre, Bayesian adaptive randomized clinical trial to establish whether therapeutic-dose parenteral anticoagulation improves outcomes for patients hospitalized...
Eligibility Criteria
Inclusion
- 1\. Patients ≥18 years of age providing (possibly through a substitute decision maker) informed consent who require hospitalization anticipated to last ≥72 hours, for microbiologically-confirmed COVID-19, enrolled \< 72 hours of hospital admission or of COVID-19 confirmation
- • If the patient is already hospitalized and the COVID-19 diagnosis is due to an outbreak or an incidental finding, then enrollment can occur within 72 hours of a clinical syndrome attributable to COVID-19 that requires continued hospitalization (e.g. new or worsening oxygen requirements or acute kidney injury) which is further anticipated to extend the hospital admission by an additional 72 hours from randomization.
Exclusion
- Patients admitted to an ICU AND receiving organ support (i.e. high flow nasal oxygen, receiving non-invasive or invasive mechanical ventilation, or are requiring vasopressor/inotrope)
- Patients for whom the intent is to not use pharmacologic thromboprophylaxis
- Active bleeding
- Risk factors for bleeding, including:
- intracranial surgery or stroke within 3 months;
- history of intracerebral arteriovenous malformation;
- cerebral aneurysm or mass lesions of the central nervous system;
- intracranial malignancy
- history of intracranial bleeding
- history of bleeding diatheses (e.g., hemophilia)
- history of gastrointestinal bleeding within previous 3 months
- thrombolysis within the previous 7 days
- presence of an epidural or spinal catheter
- recent major surgery \<14 days
- uncontrolled hypertension (sBP \>200 mmHg, dBP \>120 mmHg)
- other physician-perceived contraindications to anticoagulation
- Platelet count \<50 x10\^9/L, INR \>2.0, or baseline aPTT \>50 (if available per SOC testing)
- Hemoglobin \<80 g/L (to minimize the likelihood of requiring red blood cell transfusion if potential bleeding were to occur)
- Acute or subacute bacterial endocarditis
- History of heparin induced thrombocytopenia (HIT) or other heparin allergy including hypersensitivity
- Current use of dual antiplatelet therapy
- Patients with an independent indication for therapeutic anticoagulation
- Patients in whom imminent demise is anticipated and there is no commitment to active ongoing intervention
- Anticipated transfer to another hospital that is not a study site within 72 hours
- Enrollment in other trials related to anticoagulation or antiplatelet therapy
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2021
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04372589
Start Date
May 20 2020
End Date
May 17 2021
Last Update
July 27 2021
Active Locations (60)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Ochsner Clinic
Jefferson, Louisiana, United States, 70121
4
Maine Medical Center
Portland, Maine, United States, 04102