Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-03-31

Brief Summary

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The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.

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Detailed Description

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Conditions

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Disseminated Intravascular Coagulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AT-150

Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175%

Group Type EXPERIMENTAL

Antithrombin alfa (INN name)

Intervention Type DRUG

AT-250

Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275%

Group Type EXPERIMENTAL

Antithrombin alfa (INN name)

Intervention Type DRUG

Control

The best standard treatment for the underlying condition only

Group Type ACTIVE_COMPARATOR

Control (Standard treatment)

Intervention Type DRUG

Interventions

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Antithrombin alfa (INN name)

Intervention Type DRUG

Control (Standard treatment)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent has been obtained from the patient or his/her legally acceptable representative
* Severe sepsis
* Disseminated intravascular coagulation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No