AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Manitoba
Study ID
NCT05848713
Phase
PHASE3
Status
Recruiting
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Conditions

  • Community-acquired Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Heparin — DRUG
    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.

Study Details

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).

Key Dates

Start date
Oct 10, 2023
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
4,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Therapeutic-Dose Heparin
    Participants randomized to the investigational arm will receive a pragmatic strategy of therapeutic-dose low molecular-weight heparin (LMWH) or unfractionated heparin (UFH) administered daily for up to 14 days or until hospital discharge, whichever occurs first. Participants should start receiving study drug as soon as possible following randomization.
  • No Intervention: Usual Care
    Participants randomized to the control arm will receive usual care thromboprophylactic dose anticoagulation according to local practice. To ensure adequate separation between the study groups, the dose of heparin/LMWH used in the usual care arm should not equal more than half of the approved therapeutic dose for that agent according to local VTE treatment protocols.

Primary Outcome Measure

Ordinal endpoint reflecting survival [ Time Frame: 30 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Jonathan Paul, MD
Ochsner ClinicJeffersonLouisiana70121
Derek Vondehaar, MD
Maine Medical CentrePortlandMaine04102
Daniel Meyer, MD
Daniel Meyer, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDearbornMichigan48128-
Cooper University Health CareCamdenNew Jersey08103
Adam Green, MD
Adam Green, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Alisha Sharma, MD
Alisha Sharma, MD (PRINCIPAL_INVESTIGATOR)

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University of Chicago· Chicago, ILOchsner Clinic· Jefferson, LAMaine Medical Centre· Portland, MEHenry Ford Health System· Dearborn, MICooper University Health Care· Camden, NJMedical College of Wisconsin· Milwaukee, WI

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