Clinical trial NCT00328939: ARIXTRA Local Study For Registration In China.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thromboembolism
Knee Replacement
Hip Replacement
Keywords: ARIXTRA
prevention of DVT
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of overall DVT (deep vein thrombosis) events confirmed by ultrasound result within day 5-11 post operation.
Secondary outcomes:
measure: Occurrence of DVT with symptom and non-fatal PE (pulmonary embolism). Occurrence of fatal PE.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: GSK Investigational Site
state: Henan
city: Xi'an
country: China
facility: GSK Investigational Site
state: Shaanxi
city: Qingdao
country: China
facility: GSK Investigational Site
state: Shandong
city: Chengdu
country: China
facility: GSK Investigational Site
state: Sichuan
city: Hangzhou
country: China
facility: GSK Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: