AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
University of Manitoba
4,000 participants
Oct 10, 2023
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria7
- Patients ≥18 years of age
- Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by:
- Radiographic evidence of new or worsening infiltrate
- 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
- Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy)
- Hospital admission anticipated to last ≥72 hours from randomization
Exclusion Criteria19
- Suspected or confirmed active COVID-19 infection
- Hospital admission for \>72 hours prior to randomization
- Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment
- Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
- Patients for whom the intent is to not use pharmacologic thromboprophylaxis
- Patients with an independent indication for therapeutic-dose anticoagulation
- Patients with a contraindication to therapeutic-dose anticoagulation, including:
- Non-traumatic bleeding that requires medical evaluation or hospitalization within 30 days prior to CAP hospital admission
- History of an inherited or acquired bleeding disorder
- Cerebral aneurysm or mass lesions of the central nervous system
- Ischemic stroke within 3 months of hospital admission
- Gastrointestinal bleeding within 3 months of hospital admission
- Platelet count \<50 x109/L OR INR \>2.0 OR hemoglobin \<80 g/L at the time of screening
- Other physician-perceived contraindications to therapeutic anticoagulation
- History of heparin induced thrombocytopenia (HIT) or other heparin allergy
- Current or recent (within 7 days of screening) use of dual anti-platelet inhibitors (For example; Aspirin + one of the following; clopidogrel, ticagrelor, prasugrel)
- Patients in whom imminent death is anticipated
- Anticipated transfer to another hospital that is not a study site within 72 hours of randomization
- Enrollment in other interventional trials related to anticoagulation or antiplatelet therapy during current hospitalization
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Interventions
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(62)
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NCT05848713