Safety of Heparin in Patients With Septic Shock

This study has been withdrawn prior to enrollment.
(Sara Cheng, MD has left the Univ. of Colorado and the study has been closed.)
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01234285
First received: September 23, 2010
Last updated: May 19, 2014
Last verified: May 2014

September 23, 2010
May 19, 2014
December 2010
April 2013   (final data collection date for primary outcome measure)
Incidence of major bleeding [ Time Frame: This outcome will be measured for an average of 30 days ] [ Designated as safety issue: Yes ]

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.

Same as current
Complete list of historical versions of study NCT01234285 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety of Heparin in Patients With Septic Shock
Safety of Heparin Anticoagulation for Prevention of Death in Patients With Septic Shock.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sepsis
  • Drug: heparin
    intravenous heparin titrated to an aPTT of 40-50 seconds starting between 300-500 units per hour and adjusted every 6 hours based on aPTT, starting within 24 hours of ICU admission up to 6 days.
  • Drug: heparin
    intravenous heparin titrated to an aPTT of 50-60 seconds starting between 300-500 units per hour and adjusted every 6 hours based on aPTT, starting within 24 hours of ICU admission up to 6 days.
  • Drug: heparin
    intravenous heparin titrated to an aPTT of 40-45 seconds starting between 300-500 units per hour and adjusted every 6 hours based on aPTT, starting within 24 hours of ICU admission up to 6 days.
  • Drug: heparin
    5000 units subcutaneously three times a day, starting within 24 hours of ICU admission up to 6 days.
  • Experimental: intravenous heparin aPTT 40-50 seconds
    Patients 11-15: IV heparin, target aPTT range 40-50 seconds
    Intervention: Drug: heparin
  • Experimental: intravenous heparin
    Patients 26-40: IV heparin, target range aPTT 50-60 seconds
    Interventions:
    • Drug: heparin
    • Drug: heparin
  • Experimental: Intravenous heparin
    Patients 41-55 IV heparin, target aPTT range 60-70 seconds
    Interventions:
    • Drug: heparin
    • Drug: heparin
  • Active Comparator: sq heparin three times a day
    Patients 1-10 will receive subcutaneous heparin three times a day
    Intervention: Drug: heparin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2013
April 2013   (final data collection date for primary outcome measure)

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 -
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01234285
10-0595
Yes
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Sara Cheng, MD;PhD University of Colorado, Denver
University of Colorado, Denver
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP