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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Sepsis
Drug: heparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Heparin Anticoagulation for Prevention of Death in Patients With Septic Shock.

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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.



Enrollment: 0
Study Start Date: December 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intravenous heparin aPTT 40-50 seconds
Patients 11-15: IV heparin, target aPTT range 40-50 seconds
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.
Experimental: intravenous heparin
Patients 26-40: IV heparin, target range aPTT 50-60 seconds
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.
Experimental: Intravenous heparin
Patients 41-55 IV heparin, target aPTT range 60-70 seconds
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.
Active Comparator: sq heparin three times a day
Patients 1-10 will receive subcutaneous heparin three times a day
Drug: heparin
5000 units subcutaneously three times a day, starting within 24 hours of ICU admission up to 6 days.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234285

Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Sara Cheng, MD;PhD University of Colorado, Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01234285     History of Changes
Other Study ID Numbers: 10-0595
Study First Received: September 23, 2010
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
sepsis
septic shock
anticoagulation
intensive care unit

Additional relevant MeSH terms:
Shock, Septic
Infection
Inflammation
Pathologic Processes
Sepsis
Shock
Systemic Inflammatory Response Syndrome
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014