A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2005-08-31

Brief Summary

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The purpose of this study is to evaluate the relative efficacy and safety of prophylactic heparin co-administration during drotrecogin alfa (activated) infusion in the treatment of severe sepsis in the adult.

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Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Drotrecogin Alfa (Activated)

Intervention Type DRUG

Unfractionated heparin

Intervention Type DRUG

Low molecular weight heparin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults greater than or equal to 18 years of age
* Receiving inpatient treatment for severe sepsis
* Indicated for treatment with Drotrecogin Alfa (Activated) under approved label in the country where the patient is enrolled

Exclusion Criteria

* Contraindicated for heparin treatment
* Require a higher dose of heparin than defined in the trial
* Have acute or chronic renal failure with an estimated creatinine clearance less than 30mL/min
* Weigh more than 135 kg (297 pounds)
* Are not expected to survive 28 days given their medical condition.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No