Viewing Study NCT05848713



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Last Modification Date: 2024-10-26 @ 2:58 PM
Study NCT ID: NCT05848713
Status: RECRUITING
Last Update Posted: 2024-02-20
First Post: 2023-04-17

Brief Title: AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
Sponsor: University of Manitoba
Organization: University of Manitoba

Study Overview

Official Title: AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
Status: RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ATTACC-CAP
Brief 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
Detailed Description: The global incidence of hospitalization due to CAP is high and associated with substantive morbidity and mortality Thrombotic complications - including venous arterial and possibly microvascular - occur commonly in hospitalized patients across many etiologies of CAP Poor outcomes may be mediated by both inflammatory and thrombotic processes leading to respiratory cardiac and other end organ dysfunction There are currently no established therapies that modify the potentially maladaptive immunothrombosis pathway in CAP

Therapeutic-dose anticoagulation with heparin reduces disease progression and mortality in non-critically ill patients hospitalized with COVID-19 with an acceptable safety profile COVID-19 shares pathogenic features including activation of the inflammatory and coagulation cascades with other pneumonias Whether therapeutic-dose heparin confers similar clinical benefits in non-COVID-19 CAP is unknown

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
OZM-129 OTHER Ozmosis Research Inc None