The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).
Official Title
ThromboEMbolism Prevention Efficacy and Safety Trial (TEMPEST): A Double-Blind Four-Week Study to Assess the Efficacy, Safety, and Tolerability of SB-424323 in the Extended Prophylaxis of Patients Following Total Hip Arthroplasty
Conditions
- Thromboembolism
- Deep Vein Thrombosis
- Venous Thromboembolism
- Pulmonary Embolism
Study Type
Interventional
Study Design
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Further Details
Primary Outcome Measures:
- Incidence of VTE events during the 28-day treatment period, including death due to VTE (venous thromboembolism).
Secondary Outcome Measures:
- Secondary endpoints were the incidences of the types of VTE [DVT (deep vein thrombosis), symptomatic VTE, PE] and anti-IIa activity.
Study Start
January 2002
Eligibility & Criteria
- Ages Eligible for Study: 35 Years and above
- Genders Eligible for Study: Both
Inclusion Criteria:
- Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
- Patients who have given written informed consent to participate in this study.
Exclusion Criteria:
- Patients with a contraindication to contrast venography
- Patients with an increased risk of bleeding.
- Patients with a predefined risk for prothrombotic episodes or a history of thrombophilia.
- Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
Total Enrolment
150
Contact Details
Australian Trial Locations
- GSK Clinical Trials Call Center, Kogarah, New South Wales, 2217, Australia
- GSK Clinical Trials Call Center, Chermside, Queensland, 4032, Australia
- GSK Clinical Trials Call Center, Bedford Park, South Australia, 5042, Australia
- GSK Clinical Trials Call Center, Daw Park, South Australia, 5041, Australia
- GSK Clinical Trials Call Center, Windsor, Victoria, 3220, Australia
- GSK Clinical Trials Call Center, Ringwood East, Victoria, 3135, Australia
- GSK Clinical Trials Call Center, Geelong, Victoria, 3220, Australia
- GSK Clinical Trials Call Center, Box Hill, Victoria, 3128, Australia
Contact GlaxoSmithKline for more information
All content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.