NCT00328939CompletedPhase 3
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 240
- Locations
- 7
- Primary Endpoint
- Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
Secondary Outcomes
- Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.
Investigators
Study Sites (7)
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