Testing Heparin for community-acquired pneumonia
Official title: AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
- Phase 3
- 2 groups
- Sites in Calgary, Grande Prairie and 14 more cities
- Recruiting
Interventions
- Medication
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.
Canadian Sites (25)
22 of 25 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
- Recruiting
Nanaimo Regional General Hospital
Nanaimo, British Columbia
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
- Recruiting
Health Sciences Center Winnipeg
Winnipeg, Manitoba
- Recruiting
Grace General Hospital
Winnipeg, Manitoba
- Recruiting
St. Boniface General Hospital
Winnipeg, Manitoba
- Recruiting
Memorial University
St. John's, Newfoundland and Labrador
- Recruiting
Health Sciences North Research Institute
Greater Sudbury, Ontario
- Recruiting
Hamilton Health Sciences - Juravinski
Hamilton, Ontario
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario
- Recruiting
Markham Stouffville Hospital
Markham, Ontario
- Recruiting
Hôpital Montfort
Ottawa, Ontario
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
- Recruiting
Niagara Health System - St Catharines Site
Saint Catherines, Ontario
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
- Recruiting
McGill University Health Centre
Montreal, Quebec
- Recruiting
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec
- Recruiting
Jewish General Hospital
Montreal, Quebec
- Recruiting
CHU de Quebec-University Laval
Québec, Quebec
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
- Recruiting
Regina General Hospital
Regina, Saskatchewan
- Not yet recruiting
Grand Prairie Regional Hospital
Grande Prairie, Alberta
- Not yet recruiting
University Health Network
Toronto, Ontario
- Not yet recruiting
Centre Hospitalier de Quebec - Hotel-Dieu de Levis
Lévis, Quebec
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
Exclusion
- −History of heparin induced thrombocytopenia (HIT) or other heparin allergy
- −Suspected or confirmed active COVID-19 infection
- −Hospital admission for \>72 hours prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Other physician-perceived contraindications to therapeutic anticoagulation
- −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 siteTrial siteA hospital or clinic where a study is actually run.Read more → within 72 hours of randomization
- −Enrollment in other interventionalInterventional studyA study where participants are given something to see what happens.Read more → trials related to anticoagulation or antiplatelet therapy during current hospitalization
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Heparin.
Registry label: A: Therapeutic-Dose Heparin
Group B receives no study treatment and is followed for comparison.
Registry label: B: Usual Care
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 4,000 people.
The study is currently expected to finish around March 2029.
The main measurement is taken over: 30 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Ordinal endpointEndpointThe specific thing a study measures to answer its question.Read more → reflecting survival — measured over 30 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05848713 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About HeparinDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 30 days.
The study as a whole is currently expected to finish around 2029-03-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 4,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 18 locations, including: Calgary, Alberta, Canada; Grande Prairie, Alberta, Canada; Nanaimo, British Columbia, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; St. John's, Newfoundland and Labrador, Canada, and 12 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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).
Other Sites (1)
Henry Ford Health System
Dearborn, Michigan, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.