Heparin Anticoagulation to Improve Outcomes in Septic Shock: The HALO Pilot
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
Life-threatening infections account for 10% of all intensive care unit admissions and
constitute the second more frequent cause of death in the ICU after heart diseases. The most
common cause of death in patients admitted with life-threatening infections is multi-organ
failure that is mediated by severe inflammation. Given the relationship between inflammation
and blood clotting, blood-thinners (also called anticoagulants) have been used to decrease
inflammation and the formation of small clots. Several lines of evidence suggest that
heparin, a proven and inexpensive blood-thinner, may reduce improve survival in patients
diagnosed with life-threatening infection. The primary objective of this study is to
demonstrate the feasibility of enrolling patients in a large randomized controlled trial
investigating heparin in patients with severe infections. In this study, patients with
life-threatening infections will have an equal chance of receiving an intravenous infusion of
heparin, or a low dose of a similar drug to prevent of blood clots while patients are
immobile. The primary purpose of the study is to demonstrate that an average of 2 patients
per site, per month, can be enrolled. Other measures of feasibility include the consent rate,
the number of protocol violations that occur during the trial, and the number of dose
reductions needed due to excessive anticoagulation. To study the biologic effects of heparin
in patients with severe infection, specific laboratory markers will be measured and analyzed.
If the feasibility of the trial is confirmed, a large randomized trial designed to tell if
heparin can safely improve survival will be conducted. Given its low cost and availability,
if heparin is shown to improve survival in patients with severe infection, adoption of this
therapy on a global scale is anticipated.