Status:
WITHDRAWN
Safety of Heparin in Patients With Septic Shock
Lead Sponsor:
University of Colorado, Denver
Conditions:
Sepsis
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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 al...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 -
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01234285
Start Date
December 1 2010
End Date
October 1 2013
Last Update
May 20 2014
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045