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RECRUITINGPhase 3INTERVENTIONAL

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients ≥18 years of age 2. Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by: 1. Radiographic evidence of new or worsening infiltrate 2. One or more of the following signs and/or symptoms of lower respiratory tract infection i. New or increased cough or sputum production ii. Fever of \> 37.8C or temperature \< 36C iii. WBC \> 11 x 109/L or \< 4 x 109/L c. The primary diagnosis is believed to be CAP as per the attending physician 3. Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy) 4. Hospital admission anticipated to last ≥72 hours from randomization Who Should NOT Join This Trial: 1. Suspected or confirmed active COVID-19 infection 2. Hospital admission for \>72 hours prior to randomization 3. Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment 4. Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization 5. Patients for whom the intent is to not use pharmacologic thromboprophylaxis 6. Patients with an independent indication for therapeutic-dose anticoagulation 7. Patients with a contraindication to therapeutic-dose anticoagulation, including: 1. Non-traumatic bleeding that requires medical evaluation or hospitalization within 30 days prior to CAP hospital admission 2. History of an inherited or acquired bleeding disorder 3. Cerebral aneurysm or mass lesions of the central nervous system 4. Ischemic stroke within 3 months of hospital admission 5. Gastrointestinal bleeding within 3 months of hospital admission 6. Platelet count \<50 x109/L OR INR \>2.0 OR hemoglobin \<80 g/L at the time of screening 7. Other physician-perceived contraindications to therapeutic anticoagulation 8. History of heparin induced thrombocytopenia (HIT) or other heparin allergy ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients ≥18 years of age 2. Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by: 1. Radiographic evidence of new or worsening infiltrate 2. One or more of the following signs and/or symptoms of lower respiratory tract infection i. New or increased cough or sputum production ii. Fever of \> 37.8C or temperature \< 36C iii. WBC \> 11 x 109/L or \< 4 x 109/L c. The primary diagnosis is believed to be CAP as per the attending physician 3. Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy) 4. Hospital admission anticipated to last ≥72 hours from randomization Exclusion Criteria: 1. Suspected or confirmed active COVID-19 infection 2. Hospital admission for \>72 hours prior to randomization 3. Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment 4. Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization 5. Patients for whom the intent is to not use pharmacologic thromboprophylaxis 6. Patients with an independent indication for therapeutic-dose anticoagulation 7. Patients with a contraindication to therapeutic-dose anticoagulation, including: 1. Non-traumatic bleeding that requires medical evaluation or hospitalization within 30 days prior to CAP hospital admission 2. History of an inherited or acquired bleeding disorder 3. Cerebral aneurysm or mass lesions of the central nervous system 4. Ischemic stroke within 3 months of hospital admission 5. Gastrointestinal bleeding within 3 months of hospital admission 6. Platelet count \<50 x109/L OR INR \>2.0 OR hemoglobin \<80 g/L at the time of screening 7. Other physician-perceived contraindications to therapeutic anticoagulation 8. History of heparin induced thrombocytopenia (HIT) or other heparin allergy 9. Current or recent (within 7 days of screening) use of dual anti-platelet inhibitors (For example; Aspirin + one of the following; clopidogrel, ticagrelor, prasugrel) 10. Patients in whom imminent death is anticipated 11. Anticipated transfer to another hospital that is not a study site within 72 hours of randomization 12. Enrollment in other interventional trials related to anticoagulation or antiplatelet therapy during current hospitalization

Treatments Being Tested

DRUG

Heparin

Preference is for LMWH given ease of administration and possibility of a more favorable safety profile, if no contraindication is present. Enoxaparin, dalteparin, or tinzaparin are acceptable LMWHs to be used for patients in the investigational arm and dose should be based on measured or estimated weight of the patient. Alternatively, intravenous UFH may be used and may be preferred in the presence of significant renal compromise. Intravenous UFH is typically dosed 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, or a corresponding UFH anti-Xa level. If UFH is used, the availability of a local site policy that specifies an aPTT target in this range or a corresponding anti-Xa value is a requirement.

Locations (20)

University of Chicago
Chicago, Illinois, United States
Ochsner Clinic
Jefferson, Louisiana, United States
Maine Medical Centre
Portland, Maine, United States
Henry Ford Health System
Dearborn, Michigan, United States
Cooper University Health Care
Camden, New Jersey, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Estadual Dr. Jayme Santos Neves
Serra, Espírito Santo, Brazil
Hospital Evangelico de Vila Velha
Vila Velha, Espírito Santo, Brazil
Hospital Universitário Cassiano Antonio Moraes
Vitória, Espírito Santo, Brazil
Santa Casa de Misericordia de Itabuna
Itabuna, Estado de Bahia, Brazil
Hospital Brasilia
Brasília, Federal District, Brazil
Hospital Sao Brasilia
Brasília, Federal District, Brazil
Instituto de Cardiologia e Transplantes do Distrito Federal
Brasília, Federal District, Brazil
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Goiânia, Goiás, Brazil
Hospital Ruy Azeredo
Goiânia, Goiás, Brazil
Instituto Goiano de Oncologia e Hematologia - INGOH
Goiânia, Goiás, Brazil
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil
NUPEC-Orizonti
Belo Horizonte, Minas Gerais, Brazil
Hospital Santa Cruz
Curitiba, Paraná, Brazil
PUCPR
Curitiba, Paraná, Brazil