Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Hip Fracture Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Rate of Major Bleeding During Treatment Period
Study Overview
Brief Summary
This study is requested by PMDA to confirm the efficacy and the safety for HFS.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma).
Exclusion Criteria
- •Active, clinically significant bleeding (excluding drainage).
Outcomes
Primary Outcomes
Rate of Major Bleeding During Treatment Period
Time Frame: From the first study drug injection up to Day 17
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
Secondary Outcomes
- Rate of Proximal DVT During Treatment Period(Up to Day 17)
- Rate of PE During Treatment Period(Up to Day 17)
- Rate of DVT During Treatment Period(Up to Day 17)
- Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death(From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17))
- Number of Participants With Major Bleeding During Treatment Period(From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17))
- Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)(From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17))
- Number of Transfused Participants(From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17))
- Summary of Units Transfused(From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17))
- Rate of Symptomatic DVT(Up to Day 17)
- Rate of Distal Only DVT During Treatment Period(Up to Day 17)