4000 Participants Needed

Heparin for Community-Acquired Pneumonia

(ATTACC-CAP Trial)

Recruiting at 75 trial locations
CP
Overseen ByChantale Pineau
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently using dual anti-platelet inhibitors, you may not be eligible to participate.

What data supports the effectiveness of the drug Heparin for treating community-acquired pneumonia?

Research shows that unfractionated heparin (UFH) can improve survival in patients with sepsis-induced coagulopathy, a condition that involves blood clotting issues similar to those seen in severe pneumonia. This suggests that UFH might help in managing complications related to pneumonia.12345

Is heparin safe for use in humans?

Heparin, also known as heparin sodium or unfractionated heparin (UFH), has been used safely in humans for various conditions, primarily to prevent blood clots. While the specific safety data for its use in community-acquired pneumonia is not detailed here, its general safety profile in humans is well-established.678910

How is the drug Heparin different from other treatments for community-acquired pneumonia?

Heparin is unique because it is traditionally used as a blood thinner to prevent clots, but in this trial, it is being explored for its potential to reduce lung inflammation and coagulation issues in pneumonia. Unlike standard pneumonia treatments, which typically involve antibiotics, this approach uses Heparin's anti-inflammatory properties, possibly administered through inhalation or nasal routes, to target lung-specific issues.311121314

What is the purpose of this trial?

This trial is testing if higher doses of heparin, a blood thinner, can help patients hospitalized with pneumonia. These patients often have blood clot complications that worsen their condition. By preventing these clots, heparin might improve their recovery and reduce severe outcomes. Heparin has been shown to reduce the risk of blood clots in various patients, including those hospitalized for medical conditions and surgeries.

Research Team

Chairholder | Dr. A. F. Turgeon ...

Alexis Turgeon, MD

Principal Investigator

L'Universite Laval

RZ

Ryan Zarychanski, MD

Principal Investigator

University of Manitoba

PL

Patrick Lawler, MD

Principal Investigator

University Health Network and McGill University

SL

Sylvain Lother, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

Adults hospitalized with community-acquired pneumonia (CAP) needing oxygen, expected to stay at least 72 hours post-randomization. They must have a primary diagnosis of CAP with new or worsening lung infiltrates and symptoms of lower respiratory infection. Excluded are those admitted over 72 hours, on chronic ventilation, not using thromboprophylaxis, needing full anticoagulation for other reasons, suspected COVID-19, in ICU on life support measures at enrollment time, or with bleeding risks.

Inclusion Criteria

I am in the hospital with pneumonia confirmed by a lung scan and symptoms.
My doctor diagnosed me with community-acquired pneumonia.
I need extra oxygen to help me breathe.
See 1 more

Exclusion Criteria

I am in the ICU receiving support like ventilation or ECLS.
I need blood thinners for a health condition unrelated to the trial.
I am not planned to be given drugs to prevent blood clots.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive therapeutic-dose heparin or usual care thromboprophylaxis for up to 14 days or until hospital discharge

2 weeks
Daily administration in hospital

Follow-up

Participants are monitored for survival, bleeding events, and thrombotic events

30 days

Extended Follow-up

Participants are monitored for thrombotic events and health-related quality of life

90 to 180 days

Treatment Details

Interventions

  • Heparin
Trial Overview The trial is testing if therapeutic-dose heparin improves outcomes compared to standard care in hospitalized patients with CAP. It's an international study where participants are randomly assigned to receive either heparin or usual care and the results will be evaluated adaptively as they come in.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Therapeutic-Dose HeparinExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
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.

Heparin is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Heparin sodium for:
  • Prevention of thromboembolic disorders
  • Treatment of deep vein thrombosis
  • Treatment of pulmonary embolism
  • Prevention of clotting in extracorporeal circuits
🇺🇸
Approved in United States as Heparin sodium for:
  • Prevention and treatment of deep vein thrombosis and pulmonary embolism
  • Prevention of postoperative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery
  • Atrial fibrillation with embolization
  • Treatment of acute and chronic consumptive coagulopathy
🇨🇦
Approved in Canada as Heparin sodium for:
  • Prevention of thromboembolic disorders
  • Treatment of deep vein thrombosis
  • Treatment of pulmonary embolism

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Canadian Critical Care Trials Group

Collaborator

Trials
32
Recruited
227,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Ozmosis Research Inc.

Industry Sponsor

Trials
25
Recruited
5,200+

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

Collaborator

Trials
12
Recruited
17,500+

Research Manitoba

Collaborator

Trials
13
Recruited
17,500+

AVANTI

Collaborator

Trials
1
Recruited
4,000+

Findings from Research

In a study of 720 patients with acute venous thromboembolism (VTE), subcutaneous unfractionated heparin (UFH) was found to be as effective as fixed-dose nadroparin for preventing recurrent thromboembolic events, with similar rates of recurrence (4.2% for UFH vs. 3.9% for nadroparin).
The safety profiles were comparable, with only 1.1% of patients on UFH and 0.8% on nadroparin experiencing major bleeding, indicating that both treatments are safe options for initial VTE management.
Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism.Prandoni, P., Carnovali, M., Marchiori, A.[2006]
In a study of 3,377 patients with sepsis-induced coagulopathy, early administration of unfractionated heparin (UFH) was associated with a significant reduction in intensive care unit mortality, with a hazard ratio of 0.69, indicating a 31% lower risk of death in the ICU compared to those who did not receive heparin.
The survival benefit of UFH was particularly pronounced in patients with a sepsis-induced coagulopathy score of 4, where the hazard ratio for ICU mortality was 0.56, suggesting that targeted heparin therapy can improve outcomes in this specific patient group.
Effectiveness of early heparin therapy on outcomes in critically ill patients with sepsis-induced coagulopathy.Huang, JJ., Zou, ZY., Zhou, ZP., et al.[2023]
In a study involving 29 male Wistar rats with endotoxin-induced acute lung injury, nebulized unfractionated heparin (UFH) at doses of 6 U/g and 12 U/g significantly reduced levels of thrombin-antithrombin complex (TATc) and tumor necrosis factor-α (TNF-α), indicating effective inhibition of coagulation and inflammation.
The results suggest that the optimal dose of nebulized UFH for treating acute lung injury should not exceed 12 U/g, as higher doses (18 U/g) led to increased inflammation and lung injury, highlighting the importance of dose management in therapeutic interventions.
[The effects of three dosages of nebulized unfractionated heparin on alveolar coagulation and tissue inflammation injury in endotoxin-induced acute lung injury rat model].Wang, ZY., Wu, SN., Zhu, X.[2012]

References

Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism. [2006]
Effectiveness of early heparin therapy on outcomes in critically ill patients with sepsis-induced coagulopathy. [2023]
[The effects of three dosages of nebulized unfractionated heparin on alveolar coagulation and tissue inflammation injury in endotoxin-induced acute lung injury rat model]. [2012]
Unfractionated heparin for the treatment of venous thromboembolism: best practices and areas of uncertainty. [2012]
[Critical appraisal: Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism. Prandoni P, Carnovali M, Marchiori A, Galilei investigators. Arch Intern Med 2004; 164: 1077-83]. [2019]
What is the association of cardiovascular events with clinical failure in patients with community-acquired pneumonia? [2013]
Patients with community acquired pneumonia discharged from the emergency department according to a clinical practice guideline. [2018]
A randomized study of sequential intravenous/oral moxifloxacin in comparison to sequential intravenous ceftriaxone/oral cefuroxime axetil in patients with hospital-acquired pneumonia. [2018]
Impact of hospital-acquired pneumonia on the Medicare program. [2023]
Early improvement in severely ill patients with pneumonia treated with ceftobiprole: a retrospective analysis of two major trials. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Challenges in variation and responsiveness of unfractionated heparin. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Safety and Pharmacokinetics of Intranasally Administered Heparin. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Safety and Pharmacokinetics of Intranasally Administered Heparin. [2022]
Bleeding complications of unfractionated heparin. [2013]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security