Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy

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Detailed Description

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Conditions

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Heparin-induced Thrombocytopenia Type II

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Argatroban

Group Type EXPERIMENTAL

argatroban

Intervention Type DRUG

Interventions

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argatroban

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects aged \>= 18 years
* Females of child bearing potential must have a negative urine pregnancy test prior to entry into the study
* Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral anticoagulation
* Signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative

Exclusion Criteria

* Uncontrolled bleeding
* Severe hepatic impairment (Child-Pugh Class C)
* Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol)
* Pregnancy (exclusion by routine urine test)
* Lactating woman

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No