ARIXTRA Local Study For Registration In China.

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

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Brief Summary

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This is a local registration study in China to compare the safety and efficacy of ARIXTRA to Enoxaparine in patients undergoing elective major hip or knee replacement or a revision of components.

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Detailed Description

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Conditions

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Thromboembolism Knee Replacement Hip Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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ARIXTRA infusion

Intervention Type DRUG

Enoxaparine infusion

Intervention Type DRUG

Other Intervention Names

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ARIXTRA infusion

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing either an elective major hip or knee replacement or revision.
* Signed written informed consent. Men or women of non-child bearing potential(i.e., post menopausal or with hysterectomy of bilateral tubule ligation) or women of childbearing potential without any plan to have a child.

Exclusion Criteria

* History of serious active bleeding in last 3 month
* Concurrent or history of thrombocytopenia ( Platelet\< 100x109/L)
* History of hypersensitivity reaction to heparin, Low molecular weight heparin or pork product
* Acute bacterial endocarditis
* Congenital or acquired bleeding disease in last 3 months
* Concurrent uncontrolled ulcer or gastrointestinal disease with blood vessel dysplasia
* Concurrent hemorrhagic cerebrovascular disease or surgical history in cerebral, spine or eye
* Conditions need to leave a tubule in intradural or extradural
* Contraindication to anticoagulant or condition required to take long term oral anticoagulant
* Abnormality in hepatic (\>1.5x UNL), renal (Clcr \< 30ml/min) or cardiac function, uncontrolled hypertension or tumor Concurrent disorder of blood vessel in lower limb
* Positive result in Human Chorionic Gonadotropin test Participated in any other investigational study on Deep Vein Thrombosis prevention in last 90 days.
* Concurrently to have hip and knee or double hip/knee replacement at the same time

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No