Safety of Heparin in Patients With Septic Shock

University of Colorado Denver (CU Denver)

Status and phase: Withdrawn; Phase 2

Conditions: Sepsis

Treatments: Drug: heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT01234285

10-0595

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

intravenous heparin aPTT 40-50 seconds

Experimental group

Description:

Patients 11-15: IV heparin, target aPTT range 40-50 seconds

Treatment:

Drug: heparin

Drug: heparin

Drug: heparin

Drug: heparin

intravenous heparin

Experimental group

Description:

Patients 26-40: IV heparin, target range aPTT 50-60 seconds

Treatment:

Drug: heparin

Drug: heparin

Drug: heparin

Drug: heparin

Intravenous heparin

Experimental group

Description:

Patients 41-55 IV heparin, target aPTT range 60-70 seconds

Treatment:

Drug: heparin

Drug: heparin

Drug: heparin

Drug: heparin

sq heparin three times a day

Active Comparator group

Description:

Patients 1-10 will receive subcutaneous heparin three times a day

Treatment:

Drug: heparin

Drug: heparin

Drug: heparin

Drug: heparin