Safety of Heparin in Patients With Septic Shock

• Status: Withdrawn
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Calcium heparin; Heparin

Criteria

Inclusion Criteria:

1. Age 18-90 in the medical or surgical intensive care unit

2. Within 24 hours of diagnosis with sepsis as defined by the Bone criteria (see Appendix A);

3. Acute Physiology and Chronic Health Evaluation (APACHE II) score of > 25;

4. Signed consent

Exclusion Criteria:

1. 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.

2. History of gastrointestinal or cerebral hemorrhage within past 3 months;

3. Active bleeding;

4. Known allergy or sensitivity to heparin;

5. History of heparin-induced thrombocytopenia

6. Organ transplantation recipient -