NCT Number: NCT00328939
ARIXTRA Local Study For Registration In China.
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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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
GSK Investigational Site, Zhengzhou, Henan, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Enoxaparine infusion
DrugOther names: ARIXTRA infusion
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.
Sponsors and collaborators
Lead sponsor
GlaxoSmithKline
Industry
Registry information
Official study title
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.
Important dates
- Study start
- 2004
- First posted
- May 24, 2006
- Registry last updated
- Jun 4, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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