Clinical trial NCT01234285: Safety of Heparin in Patients With Septic Shock
Official title: Safety of Heparin Anticoagulation for Prevention of Death in Patients With Septic Shock.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Sepsis
Keywords: sepsis
septic shock
anticoagulation
intensive care unit
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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 -

Primary outcomes:
measure: Incidence of major bleeding
timeFrame: This outcome will be measured for an average of 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sara Cheng, MD;PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marshall JC. Inflammation, coagulopathy, and the pathogenesis of multiple organ dysfunction syndrome. Crit Care Med. 2001 Jul;29(7 Suppl):S99-106. doi: 10.1097/00003246-200107001-00032.
citation: Agarwal R, Gupta D. Anticoagulation in sepsis: is low-dose heparin as effective as activated protein C? Intensive Care Med. 2005 Sep;31(9):1297-8. doi: 10.1007/s00134-005-2723-0. Epub 2005 Jul 9. No abstract available.
citation: Zarychanski R, Doucette S, Fergusson D, Roberts D, Houston DS, Sharma S, Gulati H, Kumar A. Early intravenous unfractionated heparin and mortality in septic shock. Crit Care Med. 2008 Nov;36(11):2973-9. doi: 10.1097/CCM.0b013e31818b8c6b.
citation: Robertson MS. Heparin: the cheap alternative for immunomodulation in sepsis? Crit Care Resusc. 2006 Sep;8(3):235-8.
citation: Derhaschnig U, Pernerstorfer T, Knechtelsdorfer M, Hollenstein U, Panzer S, Jilma B. Evaluation of antiinflammatory and antiadhesive effects of heparins in human endotoxemia. Crit Care Med. 2003 Apr;31(4):1108-12. doi: 10.1097/01.CCM.0000059441.70680.DC.