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Anticoagulant

intravenous heparin aPTT 40-50 seconds for Sepsis

Phase 2
Waitlist Available
Led By Sara Cheng, MD;PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this outcome will be measured for an average of 30 days
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 20 Other Conditions

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.

Eligible Conditions
  • Sepsis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this outcome will be measured for an average of 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and this outcome will be measured for an average of 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of major bleeding

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: intravenous heparin aPTT 40-50 secondsExperimental Treatment1 Intervention
Patients 11-15: IV heparin, target aPTT range 40-50 seconds
Group II: intravenous heparinExperimental Treatment1 Intervention
Patients 26-40: IV heparin, target range aPTT 50-60 seconds
Group III: Intravenous heparinExperimental Treatment1 Intervention
Patients 41-55 IV heparin, target aPTT range 60-70 seconds
Group IV: sq heparin three times a dayActive Control1 Intervention
Patients 1-10 will receive subcutaneous heparin three times a day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heparin
FDA approved

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,798 Previous Clinical Trials
2,797,054 Total Patients Enrolled
8 Trials studying Sepsis
36,008 Patients Enrolled for Sepsis
Sara Cheng, MD;PhDPrincipal InvestigatorUniversity of Colorado, Denver
~0 spots leftby Oct 2025
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