Unfractioned Heparin for Treatment of Sepsis
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|ClinicalTrials.gov Identifier: NCT00100308|
Recruitment Status : Completed
First Posted : December 29, 2004
Last Update Posted : January 15, 2008
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Bacterial Infections||Drug: Unfractioned heparin Drug: saline||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||319 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Unfractioned Heparin for Treatment of Sepsis: A Randomized Clinical Trial (The HETRASE Study)|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Standard treatment plus unfractioned heparin low-dose continuous infusion
Drug: Unfractioned heparin
Low-dose continuous-infusion, 500 units/hour per seven days
Placebo Comparator: 2
Standard treatment plus placebo
- Change from baseline Multiple Organ Dysfunction (MOD) score [ Time Frame: 15 days ]
- Length of stay [ Time Frame: During hospitalization ]
- 28-day all-cause mortality [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100308
|Hospital Universitario San Vicente de Paul|
|Medellin, Antioquia, Colombia|
|Principal Investigator:||Fabián A Jaimes, MD, MSc, PhD||Universidad de Antioquia|