ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

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