Sepsis Clinical Trial
Official title:
Unfractioned Heparin for Treatment of Sepsis: A Randomized Clinical Trial (The HETRASE Study)
The purpose of this study is to determine whether low dose continuous infusion of unfractioned heparin (500 units/hour), in addition to the standard treatment, is efficacious as complementary therapy for sepsis patients.
Sepsis is considered a leading cause of death worldwide with approximately 18 million cases
annually and a mortality rate of almost 30%. The search for efficacious therapeutic
approaches has largely failed and only a few of the recent interventions, such as activated
protein C and low dose steroids, have shown some success in improving survival. However,
these interventions were tested only in patients with severe sepsis and/or septic shock and
although these groups exhibit the highest mortality, they represent less than 50% of the
total affected population. Furthermore, these interventions necessitate special devices,
tests and/or drugs that might be unavailable or simply unaffordable in resource-limited
settings.
Animal and human models have suggested that heparin, in addition to successfully inhibiting
the coagulation cascade, may also modulate the wide array of responses to infection.
Furthermore, the three clinical trials for recombinant anticoagulants allowed the use of
prophylactic treatment for venous thrombosis with a dose of unfractioned heparin (UFH) of up
to 10,000 or 15,000 units subcutaneously per day. When those who did receive heparin were
compared to those who did not in the placebo arms of the clinical trials, all three studies
showed a higher mortality in the subgroups that did not receive heparin. Although this is
not a randomized comparison, a constant result in three different study populations with
variable entry criteria, along with the natural heterogeneity of the illness, strongly
fosters the hypothesis that heparin might reduce, beyond its known anticoagulant and
antithrombotic properties, the overall mortality for sepsis.
In this project, we propose a phase II/III, randomized, double-masked, placebo-controlled,
single-center clinical trial with a total sample size of 310 patients, for testing low dose
continuous infusions of UFH (500 units/hour) for 7 days, as complementary treatment for
septic patients. Our primary aims are to estimate the effects of UFH on length of stay and
change from baseline Multiple Organic Dysfunction (MOD) score. Secondary objectives are to
estimate the effects of UFH on 28-day all-cause mortality, and to estimate the possible
effect-modification on 28-day all-cause mortality, in subgroups defined by site of infection
and baseline values of APACHE II score, MOD score and D-dimer.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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