ARIXTRA Local Study For Registration In China.

Randomized, Single Blind, Parallel Study to Compare the Safety and Efficacy of ARIXTRA to Enoxaparine in Patients Undergoing Elective Major Hip or Knee Replacement or a Revision of Components.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00328939

Enrollment

240

Registered

2006-05-24

Start date

2004-05-31

Completion date

Unknown

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Replacement, Knee Replacement, Thromboembolism

Keywords

ARIXTRA, prevention of DVT

Brief summary

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.

Interventions

DRUGARIXTRA infusion

DRUGEnoxaparine infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.	—

Secondary

Measure	Time frame
Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026