TerminatedPhase 2ACTRN12607000157471

Heparin in Severe Sepsis

Does Heparin improve survivial in severe sepsis? A pilot feasability study


Sponsor

Dr Megan S Robertson

Enrollment

40 participants

Start Date

Nov 14, 2007

Study Type

Interventional

Conditions

Summary

In Australia and New Zealand, around 5000 patients are admitted to Intensive Care Units (ICU) annually with severe infection (sepsis). Despite aggressive treatment, around 35% of these patients will not survive, making severe sepsis the most common non-cardiac cause of death in ICU patients. Even surviving patients often suffer a period of multiple organ failure. Most patients admitted to ICU receive heparin injections to prevent the formation of blood clots in the leg veins which can travel to the lungs, causing major breathing difficulties. Traditionally, the agent most commonly given to prevent blood clots was unfractionated heparin, but over the last decade, more purified forms of heparin (low and ultra-low molecular weight heparins) have become available. These more modern agents are replacing the traditional heparin for blood clot prevention because of reported increased effectiveness. Recent studies in animals, healthy humans and critically ill patients with severe sepsis have suggested that unfractionated heparin may have beneficial therapeutic effects in infection, additional to its action to prevent blood clots. These immune-active effects are related to molecular size and thus may be lost with the current trend to use purified heparin forms. If this is true, then this additional benefit may be lost as we change to more purified heparin forms. We aim to perform a pilot study to assess the feasibility of conducting a large multi-centre study to investigate whether unfractionated heparin is beneficial for patients with severe sepsis. If unfractionated heparin is shown to be beneficial in these patients, this would be a simple, cheap and widely applicable additional treatment for severe infection that could save lives world-wide, and be accessible in first to third-world environments.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether heparin (a blood-thinning medication) improves outcomes in adults with severe sepsis, a life-threatening response to infection. It is for patients aged 18 and older who develop severe sepsis and can start treatment within 24 hours. Participants must not already be on full anticoagulation therapy or have contraindications to heparin.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Blinded study of low-dose intravenous unfractionated heparin (UFH) (control) compared to subcutaneous fondaparinux (intervention) in patients with severe sepsis. Fondaparinux: an injection of fond

Blinded study of low-dose intravenous unfractionated heparin (UFH) (control) compared to subcutaneous fondaparinux (intervention) in patients with severe sepsis. Fondaparinux: an injection of fondaparinux 2.5mg in 0.5ml of saline for injection will be administered subcutaneously daily for 7 days commencing within 24 hours of onset of severe sepsis. For blinding purposes, a continuous infusion of normal saline will also be required at the same time as the control arm. Duration of the study is 7 days in both arms.


Locations(1)

Australia

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ACTRN12607000157471


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