Back to resultsAntithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC) (ATTACC)
Primary Purpose
COVID-19, Pneumonia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Heparin
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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
Sites / Locations
- Emory University Hospital Midtown
- University of Chicago
- Ochsner Clinic
- Maine Medical Center
- Henry Ford University
- Beaumont Hospital
- Mayo Clinic
- Saint Louis University School of Medicine/Saint Louis Veterans Affairs Medical Center
- Cooper University Health Care
- Hackensack University Medical Center
- Saint Barnabas Medical Center
- Montefiore-Einstein Center for Heart and Vascular Care
- Vanderbilt University Medical Center
- Santa Casa de Misericordia de Itabuna
- Hospital Unimed do Cariri
- Instituto Goiano de Oncologia e Hematologia - INGOH
- Centro de Pesquisas Clínicas Humap - UFMS
- Hospital Felício Rocho
- Clinica de Campo Grande S/A
- Unimed Campo Grande
- Hospital Agamenon Magalhaes
- Hospital das Clinicas da UFPR
- Pontifícia Universidade Católica do Paraná
- Parana Medical Research Center
- Hospital Sao Vicente de Paulo
- Hospital Universitario Pedro Ernesto
- Hospital de Clinicas de Porto Alegre
- Instituto de Cardiologia do Rio Grande do Sul
- Instituto de Medicina Vascular
- AngioCor Blumenau
- Instituto de Cardiologia de Santa Catarina
- Instituto de Pesquisa Clínica de Campinas
- Praxis Pesquisa Medica
- Santa Casa de Votuporanga
- Casa de Saúde Santa Marcelina
- Instituto de Molestias Cardio Vasculares de Tatui
- Hospital 9 de Julho
- Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
- Instituto de Infectologia Emilio Ribas
- Instituto do Coração do Estado de São Paulo
- Sociedade Beneficente Israelita Hospital Albert Einstein
- Victoria General Hospital
- Health Sciences Center Winnipeg
- Grace General Hospital
- St. Boniface General Hospital
- Hamilton Health Sciences
- St. Joseph's Healthcare Hamilton
- Hôpital Montfort
- The Ottawa Hospital
- University Health Network
- McGill University Health Centre
- Centre Hospitalier de l'université de Montréal (CHUM)
- Jewish General Hospital
- CHU de Quebec-University Laval
- Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ)
- Centre Hospitalier Universitaire de Sherbrooke
- Regina General Hospital
- Hospital de Infectolog´ñia Centro Médico Nacional La Raza
- Hospital General Regional 1 Carlos MacGregor Sánchez Navarro
- Hospital General regional 2 El Marqués
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Investigational arm
Control arm
Arm Description
Participants randomized to the investigational arm will receive therapeutic anticoagulation for 14 days (or until hospital discharge or liberation from supplemental oxygen >24 hours if previously required, whichever comes first) with heparin, with preference for subcutaneous low molecular weight heparin (enoxaparin preferred, although dalteparin or tinzaparin are also acceptable, as available) if no contraindication is present; alternatively, intravenous unfractionated heparin infusion may be used.
Participants will receive usual care of thromboprophylactic dose anticoagulation according to local practice.
Outcomes
Primary Outcome Measures
Mortality and days free of organ support
The primary endpoint in the trial is days alive and free of organ support at day 21. This endpoint is defined as the number of days that a patient is alive and free of organ support through the first 21 days after trial entry. Organ support is defined as receipt of invasive or non-invasive mechanical ventilation, high flow nasal oxygen (>30 L/min), vasopressor therapy, or ECMO support. Death at any time (including beyond 21 days) during the index hospital stay is assigned the worst possible score of -1.
Secondary Outcome Measures
Arterial and venous thrombotic conditions
A composite endpoint of death, deep vein thrombosis, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke collected during hospitalization or at 28 days and 90 days after enrollment (whichever is earlier).
Intubation and mortality
Ordered categorical endpoint with three possible outcomes based on the worst status of each patient through day 30 following randomization: no invasive mechanical ventilation, invasive mechanical ventilation, or death.
All-cause mortality
Intubation
Invasive mechanical ventilation.
Hospital-free days
Days alive outside of the hospital through 28 days following randomization.
Ventilator-free days
Days alive not on a ventilator assessed at 28 days following randomization.
Myocardial infarction
Ischaemic stroke
Venous thromboembolism
Symptomatic proximal venous thromboembolism (DVT or PE).
Vasopressor-free days
Days alive not on a vasopressor assessed at 28 days following randomization.
Renal replacement free days
Days alive not on renal replacement assessed at 28 days following randomization.
Hospital re-admission
Hospital re-admission within 28 days.
Acute kidney injury
As defined by KDIGO criteria.
Systemic arterial thrombosis or embolism
ECMO support
Use of extracorporeal membrane oxygenation (ECMO) support.
Mechanical circuit thrombosis
Dialysis or ECMO.
WHO ordinal scale
Peak scale over 28 days, scale at 14 days, and proportion with improvement by at least 2 categories compared to enrollment, at 28 days.
Major bleeding
As defined by the International Society on Thrombosis and Haemostasis (ISTH).
Heparin-induced thrombocytopenia (HIT)
Laboratory-confirmed.
Full Information
NCT ID
NCT04372589
First Posted
April 24, 2020
Last Updated
July 26, 2021
Sponsor
University of Manitoba
Collaborators
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04372589
Brief Title
Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC)
Acronym
ATTACC
Official Title
Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC), in Collaboration With Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-4)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
May 17, 2021 (Actual)
Study Completion Date
May 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 contribute to morbidity, organ failure, and death. Therapeutic anticoagulation with heparin may improve clinical outcomes in patients with COVID-19 through anti-thrombotic, anti-inflammatory, and anti-viral activities of heparins. This pragmatic, Bayesian adaptive randomized controlled trial will determine whether therapeutic anticoagulation with heparin (subcutaneous low molecular weight heparin or intravenous unfractionated heparin) versus usual care reduces the need for intubation or death in hospitalized patients with COVID-19. The trial uses an adaptive design which was chosen to overcome limitations in available data to inform a priori estimation of event rates and possible effect sizes. The adaptive design also includes response-adaptive randomization based on baseline D-dimer level, probing for differential efficacy across subgroups defined based on initial D-dimer level. This Bayesian adaptive randomized trial will stop at a conclusion 1) when the posterior probability that the proportional odds ratio is greater than 1.0 reaches 99% (definition of benefit); 2) when the posterior probability that the proportional odds ratio is greater than 1.2 is less than 10% (definition of futility) or; 3) when the posterior probability that the proportional odds ratio is less than 1.0 is greater than 90% (definition of harm). The trial will enroll a maximum of 3,000 patients, although in many simulations the trial may require fewer patients. The trial is strategically aligned with the international REMAP-CAP/COVID platform trial to accelerate evidence generation.
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 with COVID-19 (e.g., reduces intubation or mortality). Participants will be randomized either to the investigational arm (therapeutic anticoagulation with heparin for 14 days or until "recovery" [defined as hospital discharge or liberation from supplemental oxygen if initially required], whichever comes first), or to the control arm (usual care, including thromboprophylactic dose anticoagulation according to local practice).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic, Bayesian adaptive randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational arm
Arm Type
Experimental
Arm Description
Participants randomized to the investigational arm will receive therapeutic anticoagulation for 14 days (or until hospital discharge or liberation from supplemental oxygen >24 hours if previously required, whichever comes first) with heparin, with preference for subcutaneous low molecular weight heparin (enoxaparin preferred, although dalteparin or tinzaparin are also acceptable, as available) if no contraindication is present; alternatively, intravenous unfractionated heparin infusion may be used.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Participants will receive usual care of thromboprophylactic dose anticoagulation according to local practice.
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
Low molecular weight heparin (LMWH) Preferred therapeutic anticoagulant is enoxaparin. Generally regimens: 1.5 mg/kg subcutaneous once daily or 1 mg/kg subcutaneous twice daily. Alternatively, other subcutaneous LMWH used, including tinzaparin (175 anti-Xa IU/kg subcutaneous once daily) or dalteparin (200 IU/kg subcutaneous once daily or 100 IU/kg subcutaneous twice a day).
Unfractionated heparin (UFH) Commenced, administered, and monitored according to local hospital policy, and guidelines that are used for the treatment of venous thromboembolism (i.e. not for acute coronary syndrome). Intravenous infusion of UFH is according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin time (aPTT) of 1.5-2.5x the reference value. If UFH is used, the availability of a local hospital policy that has specifies an aPTT target in this range or an anti-Xa value is a requirement.
Primary Outcome Measure Information:
Title
Mortality and days free of organ support
Description
The primary endpoint in the trial is days alive and free of organ support at day 21. This endpoint is defined as the number of days that a patient is alive and free of organ support through the first 21 days after trial entry. Organ support is defined as receipt of invasive or non-invasive mechanical ventilation, high flow nasal oxygen (>30 L/min), vasopressor therapy, or ECMO support. Death at any time (including beyond 21 days) during the index hospital stay is assigned the worst possible score of -1.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Arterial and venous thrombotic conditions
Description
A composite endpoint of death, deep vein thrombosis, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke collected during hospitalization or at 28 days and 90 days after enrollment (whichever is earlier).
Time Frame
28 days and 90 days
Title
Intubation and mortality
Description
Ordered categorical endpoint with three possible outcomes based on the worst status of each patient through day 30 following randomization: no invasive mechanical ventilation, invasive mechanical ventilation, or death.
Time Frame
30 days
Title
All-cause mortality
Time Frame
28 days and 90 days
Title
Intubation
Description
Invasive mechanical ventilation.
Time Frame
30 days
Title
Hospital-free days
Description
Days alive outside of the hospital through 28 days following randomization.
Time Frame
28 days
Title
Ventilator-free days
Description
Days alive not on a ventilator assessed at 28 days following randomization.
Time Frame
28 days
Title
Myocardial infarction
Time Frame
28 days and 90 days
Title
Ischaemic stroke
Time Frame
28 days and 90 days
Title
Venous thromboembolism
Description
Symptomatic proximal venous thromboembolism (DVT or PE).
Time Frame
28 days and 90 days
Title
Vasopressor-free days
Description
Days alive not on a vasopressor assessed at 28 days following randomization.
Time Frame
28 days
Title
Renal replacement free days
Description
Days alive not on renal replacement assessed at 28 days following randomization.
Time Frame
28 days
Title
Hospital re-admission
Description
Hospital re-admission within 28 days.
Time Frame
28 days
Title
Acute kidney injury
Description
As defined by KDIGO criteria.
Time Frame
Duration of study
Title
Systemic arterial thrombosis or embolism
Time Frame
28 days and 90 days
Title
ECMO support
Description
Use of extracorporeal membrane oxygenation (ECMO) support.
Time Frame
Duration of study
Title
Mechanical circuit thrombosis
Description
Dialysis or ECMO.
Time Frame
Duration of study
Title
WHO ordinal scale
Description
Peak scale over 28 days, scale at 14 days, and proportion with improvement by at least 2 categories compared to enrollment, at 28 days.
Time Frame
28 days
Title
Major bleeding
Description
As defined by the International Society on Thrombosis and Haemostasis (ISTH).
Time Frame
Intervention period (maximum 14 days)
Title
Heparin-induced thrombocytopenia (HIT)
Description
Laboratory-confirmed.
Time Frame
Intervention period (maximum 14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick R. Lawler, MD, MPH
Organizational Affiliation
Peter Munk Cardiac Centre/University Health Network
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ewan C. Goligher, MD, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ryan Zarychanski, MD, MSc
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ochsner Clinic
City
Jefferson
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Henry Ford University
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48128
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Louis University School of Medicine/Saint Louis Veterans Affairs Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Cooper University Health Care
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Montefiore-Einstein Center for Heart and Vascular Care
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Santa Casa de Misericordia de Itabuna
City
Itabuna
State/Province
BA
Country
Brazil
Facility Name
Hospital Unimed do Cariri
City
Juazeiro do Norte
State/Province
CE
Country
Brazil
Facility Name
Instituto Goiano de Oncologia e Hematologia - INGOH
City
Goiania
State/Province
Goias
Country
Brazil
Facility Name
Centro de Pesquisas Clínicas Humap - UFMS
City
Campo Grande
State/Province
Mato Grosso Do Sul
Country
Brazil
Facility Name
Hospital Felício Rocho
City
Belo Horizonte
State/Province
MG
Country
Brazil
Facility Name
Clinica de Campo Grande S/A
City
Campo Grande
State/Province
MS
Country
Brazil
Facility Name
Unimed Campo Grande
City
Campo Grande
State/Province
MS
Country
Brazil
Facility Name
Hospital Agamenon Magalhaes
City
Recife
State/Province
Pernanbuco
Country
Brazil
Facility Name
Hospital das Clinicas da UFPR
City
Curitiba
State/Province
PR
Country
Brazil
Facility Name
Pontifícia Universidade Católica do Paraná
City
Curitiba
State/Province
PR
Country
Brazil
Facility Name
Parana Medical Research Center
City
Maringa
State/Province
PR
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital Universitario Pedro Ernesto
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Instituto de Cardiologia do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Instituto de Medicina Vascular
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
AngioCor Blumenau
City
Blumenau
State/Province
Santa Catarina
Country
Brazil
Facility Name
Instituto de Cardiologia de Santa Catarina
City
Sao Jose
State/Province
Santa Catarina
Country
Brazil
Facility Name
Instituto de Pesquisa Clínica de Campinas
City
Campinas
State/Province
Sao Paulo
Country
Brazil
Facility Name
Praxis Pesquisa Medica
City
Santo Andre
State/Province
Sao Paulo
Country
Brazil
Facility Name
Santa Casa de Votuporanga
City
Votuporanga
State/Province
Sao Paulo
Country
Brazil
Facility Name
Casa de Saúde Santa Marcelina
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Instituto de Molestias Cardio Vasculares de Tatui
City
Tatui
State/Province
SP
Country
Brazil
Facility Name
Hospital 9 de Julho
City
São Paulo
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
Country
Brazil
Facility Name
Instituto de Infectologia Emilio Ribas
City
São Paulo
Country
Brazil
Facility Name
Instituto do Coração do Estado de São Paulo
City
São Paulo
Country
Brazil
Facility Name
Sociedade Beneficente Israelita Hospital Albert Einstein
City
São Paulo
Country
Brazil
Facility Name
Victoria General Hospital
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Health Sciences Center Winnipeg
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Grace General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Hôpital Montfort
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Facility Name
Centre Hospitalier de l'université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
CHU de Quebec-University Laval
City
Québec
State/Province
Quebec
Country
Canada
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ)
City
Québec
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Regina General Hospital
City
Regina
State/Province
Saskatchewan
Country
Canada
Facility Name
Hospital de Infectolog´ñia Centro Médico Nacional La Raza
City
Azcapotzalco
State/Province
Mexico City
Country
Mexico
Facility Name
Hospital General Regional 1 Carlos MacGregor Sánchez Navarro
City
Benito Juárez
State/Province
Mexico City
Country
Mexico
Facility Name
Hospital General regional 2 El Marqués
City
Querétaro
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
34351722
Citation
REMAP-CAP Investigators; ACTIV-4a Investigators; ATTACC Investigators; Goligher EC, Bradbury CA, McVerry BJ, Lawler PR, Berger JS, Gong MN, Carrier M, Reynolds HR, Kumar A, Turgeon AF, Kornblith LZ, Kahn SR, Marshall JC, Kim KS, Houston BL, Derde LPG, Cushman M, Tritschler T, Angus DC, Godoy LC, McQuilten Z, Kirwan BA, Farkouh ME, Brooks MM, Lewis RJ, Berry LR, Lorenzi E, Gordon AC, Ahuja T, Al-Beidh F, Annane D, Arabi YM, Aryal D, Baumann Kreuziger L, Beane A, Bhimani Z, Bihari S, Billett HH, Bond L, Bonten M, Brunkhorst F, Buxton M, Buzgau A, Castellucci LA, Chekuri S, Chen JT, Cheng AC, Chkhikvadze T, Coiffard B, Contreras A, Costantini TW, de Brouwer S, Detry MA, Duggal A, Dzavik V, Effron MB, Eng HF, Escobedo J, Estcourt LJ, Everett BM, Fergusson DA, Fitzgerald M, Fowler RA, Froess JD, Fu Z, Galanaud JP, Galen BT, Gandotra S, Girard TD, Goodman AL, Goossens H, Green C, Greenstein YY, Gross PL, Haniffa R, Hegde SM, Hendrickson CM, Higgins AM, Hindenburg AA, Hope AA, Horowitz JM, Horvat CM, Huang DT, Hudock K, Hunt BJ, Husain M, Hyzy RC, Jacobson JR, Jayakumar D, Keller NM, Khan A, Kim Y, Kindzelski A, King AJ, Knudson MM, Kornblith AE, Kutcher ME, Laffan MA, Lamontagne F, Le Gal G, Leeper CM, Leifer ES, Lim G, Gallego Lima F, Linstrum K, Litton E, Lopez-Sendon J, Lother SA, Marten N, Saud Marinez A, Martinez M, Mateos Garcia E, Mavromichalis S, McAuley DF, McDonald EG, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Mouncey PR, Murthy S, Nair GB, Nair R, Nichol AD, Nicolau JC, Nunez-Garcia B, Park JJ, Park PK, Parke RL, Parker JC, Parnia S, Paul JD, Pompilio M, Quigley JG, Rosenson RS, Rost NS, Rowan K, Santos FO, Santos M, Santos MO, Satterwhite L, Saunders CT, Schreiber J, Schutgens REG, Seymour CW, Siegal DM, Silva DG Jr, Singhal AB, Slutsky AS, Solvason D, Stanworth SJ, Turner AM, van Bentum-Puijk W, van de Veerdonk FL, van Diepen S, Vazquez-Grande G, Wahid L, Wareham V, Widmer RJ, Wilson JG, Yuriditsky E, Zhong Y, Berry SM, McArthur CJ, Neal MD, Hochman JS, Webb SA, Zarychanski R. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):777-789. doi: 10.1056/NEJMoa2103417. Epub 2021 Aug 4.
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PubMed Identifier
34351721
Citation
ATTACC Investigators; ACTIV-4a Investigators; REMAP-CAP Investigators; Lawler PR, Goligher EC, Berger JS, Neal MD, McVerry BJ, Nicolau JC, Gong MN, Carrier M, Rosenson RS, Reynolds HR, Turgeon AF, Escobedo J, Huang DT, Bradbury CA, Houston BL, Kornblith LZ, Kumar A, Kahn SR, Cushman M, McQuilten Z, Slutsky AS, Kim KS, Gordon AC, Kirwan BA, Brooks MM, Higgins AM, Lewis RJ, Lorenzi E, Berry SM, Berry LR, Aday AW, Al-Beidh F, Annane D, Arabi YM, Aryal D, Baumann Kreuziger L, Beane A, Bhimani Z, Bihari S, Billett HH, Bond L, Bonten M, Brunkhorst F, Buxton M, Buzgau A, Castellucci LA, Chekuri S, Chen JT, Cheng AC, Chkhikvadze T, Coiffard B, Costantini TW, de Brouwer S, Derde LPG, Detry MA, Duggal A, Dzavik V, Effron MB, Estcourt LJ, Everett BM, Fergusson DA, Fitzgerald M, Fowler RA, Galanaud JP, Galen BT, Gandotra S, Garcia-Madrona S, Girard TD, Godoy LC, Goodman AL, Goossens H, Green C, Greenstein YY, Gross PL, Hamburg NM, Haniffa R, Hanna G, Hanna N, Hegde SM, Hendrickson CM, Hite RD, Hindenburg AA, Hope AA, Horowitz JM, Horvat CM, Hudock K, Hunt BJ, Husain M, Hyzy RC, Iyer VN, Jacobson JR, Jayakumar D, Keller NM, Khan A, Kim Y, Kindzelski AL, King AJ, Knudson MM, Kornblith AE, Krishnan V, Kutcher ME, Laffan MA, Lamontagne F, Le Gal G, Leeper CM, Leifer ES, Lim G, Lima FG, Linstrum K, Litton E, Lopez-Sendon J, Lopez-Sendon Moreno JL, Lother SA, Malhotra S, Marcos M, Saud Marinez A, Marshall JC, Marten N, Matthay MA, McAuley DF, McDonald EG, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Moore SC, Morillo Guerrero R, Mouncey PR, Murthy S, Nair GB, Nair R, Nichol AD, Nunez-Garcia B, Pandey A, Park PK, Parke RL, Parker JC, Parnia S, Paul JD, Perez Gonzalez YS, Pompilio M, Prekker ME, Quigley JG, Rost NS, Rowan K, Santos FO, Santos M, Olombrada Santos M, Satterwhite L, Saunders CT, Schutgens REG, Seymour CW, Siegal DM, Silva DG Jr, Shankar-Hari M, Sheehan JP, Singhal AB, Solvason D, Stanworth SJ, Tritschler T, Turner AM, van Bentum-Puijk W, van de Veerdonk FL, van Diepen S, Vazquez-Grande G, Wahid L, Wareham V, Wells BJ, Widmer RJ, Wilson JG, Yuriditsky E, Zampieri FG, Angus DC, McArthur CJ, Webb SA, Farkouh ME, Hochman JS, Zarychanski R. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):790-802. doi: 10.1056/NEJMoa2105911. Epub 2021 Aug 4.
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PubMed Identifier
33502773
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Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
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PubMed Identifier
32815416
Citation
Houston BL, Lawler PR, Goligher EC, Farkouh ME, Bradbury C, Carrier M, Dzavik V, Fergusson DA, Fowler RA, Galanaud JP, Gross PL, McDonald EG, Husain M, Kahn SR, Kumar A, Marshall J, Murthy S, Slutsky AS, Turgeon AF, Berry SM, Rosenson RS, Escobedo J, Nicolau JC, Bond L, Kirwan BA, de Brouwer S, Zarychanski R. Anti-Thrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC): Study design and methodology for an international, adaptive Bayesian randomized controlled trial. Clin Trials. 2020 Oct;17(5):491-500. doi: 10.1177/1740774520943846. Epub 2020 Aug 20.
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PubMed Identifier
32407672
Citation
Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available.
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Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC)
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