ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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 prethrombotic episodes or a history of thrombophilia.

• Other inclusion or exclusion criteria to be determined by the physician and study sponsor.