Safety of Heparin in Patients With Septic Shock

Phase 2

Withdrawn

• Conditions: Sepsis
• Interventions: Drug: heparin

• Registration Number: NCT01234285
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Study Start: 2010-12
• Primary Completion: 2013-04
• Study Completion: 2013-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous heparin aPTT 40-50 seconds	heparin	Patients 11-15: IV heparin, target aPTT range 40-50 seconds
sq heparin three times a day	heparin	Patients 1-10 will receive subcutaneous heparin three times a day
intravenous heparin	heparin	Patients 26-40: IV heparin, target range aPTT 50-60 seconds
Intravenous heparin	heparin	Patients 41-55 IV heparin, target aPTT range 60-70 seconds

Primary Outcome Measures

Name	Time	Method
Incidence of major bleeding	This outcome will be measured for an average of 30 days	Defined as:decrease in hemoglobin greater than 2g/dl and/or transfusion of 2 or more units of packed red blood cells.; However, if there are obvious other reasons for bleeding, such as within 12 hours of major surgery, coagulopathy unrelated to heparin or an anatomical basis.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States