Safety of Heparin in Patients With Septic Shock
Withdrawn before enrolling · Phase 2
Conditions studied: Sepsis
In brief
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.
Key facts
- Study ID
- NCT01234285
- Run by
- University of Colorado, Denver
- People needed
- 0
- Starts
- 2010-12-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2014-05-20
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-90 in the medical or surgical intensive care unit
- Within 24 hours of diagnosis with sepsis as defined by the Bone criteria (see Appendix A);
- Acute Physiology and Chronic Health Evaluation (APACHE II) score of > 25;
- Signed consent
You may not qualify if…
- Currently therapeutically anticoagulated for known thrombotic diagnosis (myocardial infarction, venous thromboembolism) known molecular hypercoagulable state (Factor V Leiden, lupus anticoagulant, antiphospholipid antibody syndrome); or use of cardiopulmonary support machines (left-ventricular assist device, intra-aortic balloon pump, veno-venous ultrafiltration, or extracorporeal membrane oxygenation.
- History of gastrointestinal or cerebral hemorrhage within past 3 months;
- Active bleeding;
- Known allergy or sensitivity to heparin;
- History of heparin-induced thrombocytopenia
- Organ transplantation recipient -
Where it is running
- University of Colorado Hospital — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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