RECRUITING

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Conditions

Community-acquired Pneumonia Pneumonia Heparin Anticoagulation Community acquired pneumonia Unfractionated Heparin Low Molecular Weight Heparin Dalteparin Enoxaparin Tinzaparin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Quick Facts

Study Start:2023-10-10

Study Completion:2029-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05848713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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	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

Inclusion Criteria

Exclusion 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
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

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

Contacts and Locations

Study Contact

Chantale Pineau

CONTACT

2042353223

attacc.cap@umanitoba.ca

Principal Investigator

Ryan Zarychanski, MD

PRINCIPAL_INVESTIGATOR

University of Manitoba

Patrick Lawler, MD

PRINCIPAL_INVESTIGATOR

University Health Network and McGill University

Sylvain Lother, MD

PRINCIPAL_INVESTIGATOR

University of Manitoba

Alexis Turgeon, MD

PRINCIPAL_INVESTIGATOR

L'Universite Laval

Study Locations (Sites)

University of Chicago

Chicago, Illinois, 60637

United States

Ochsner Clinic

Jefferson, Louisiana, 70121

United States

Maine Medical Centre

Portland, Maine, 04102

United States

Henry Ford University

Dearborn, Michigan, 48128

United States

Cooper University Health Care

Camden, New Jersey, 08103

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: University of Manitoba

Ryan Zarychanski, MD, PRINCIPAL_INVESTIGATOR, University of Manitoba
Patrick Lawler, MD, PRINCIPAL_INVESTIGATOR, University Health Network and McGill University
Sylvain Lother, MD, PRINCIPAL_INVESTIGATOR, University of Manitoba
Alexis Turgeon, MD, PRINCIPAL_INVESTIGATOR, L'Universite Laval

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-10

Study Completion Date2029-03-31

Study Record Updates

Study Start Date2023-10-10

Study Completion Date2029-03-31

Terms related to this study

Keywords Provided by Researchers

Pneumonia
Heparin
Anticoagulation
Community acquired pneumonia
Unfractionated Heparin
Low Molecular Weight Heparin
Dalteparin
Enoxaparin
Tinzaparin

Additional Relevant MeSH Terms

Community-acquired Pneumonia