AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

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).

Conditions

• Community-acquired Pneumonia

Interventions

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Research Manitoba

  collaborator OTHER

• Ozmosis Research Inc.

  collaborator INDUSTRY

• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

  collaborator NETWORK

• Canadian Critical Care Trials Group

  collaborator OTHER

• Avanti PC

  collaborator UNKNOWN

• Aurora Clinical Research

  collaborator UNKNOWN

• University of Manitoba

  lead OTHER

Principal Investigators

• Ryan Zarychanski, MD · University of Manitoba

• Patrick Lawler, MD · University Health Network and McGill University

• Sylvain Lother, MD · University of Manitoba

• Alexis Turgeon, MD · L'Universite Laval

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-10

Primary Completion

2028-03-31

Completion

2029-03-31

FDA Drug

Yes

Countries

• United States
• Brazil
• Canada

Study Locations