drugset / Trial / NCT01234285

Safety of Heparin in Patients With Septic Shock

NCT01234285

Phase 2 Withdrawn University of Colorado, Denver
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Sepsis is a syndrome comprised of a systemic inflammatory response, signs of tissue hypoperfusion, and organ in the setting of presumed infection. Heparin, in addition to being an anticoagulant, is also a well-known antiinflammatory. The investigators believe that unfractionated heparin has the potential to save the lives of septic patients at a drastically reduced cost. This is a dose escalation study to determine the safety of increasing levels of heparin in this patient population; compare markers of anticoagulation and inflammation between treatment groups; and compare clinical outcomes between groups.

Timeline

Start
2010-12
Primary completion
2013-04
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Heparin Other / unclassified 300 iu Intravenous
Comparator Heparin Other / unclassified 500 iu Intravenous
Comparator Heparin Other / unclassified 5000 iu Intravenous