Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Elective Total Hip Replacement Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period
研究概览
简要总结
This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing either an elective primary THR (total hip replacement) surgery or a revision of a THR.
排除标准
- •Active, clinically significant bleeding (excluding drainage).
结局指标
主要结局
Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period
时间窗: Up to Day 17
The percentage of participants with VTE, who underwent elective total hip replacement surgery, detected by routine venography, during the treatment period were reported. The percentage VTE was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
Percentage of Participants With Major Bleeding
时间窗: Up to Day 17
Major bleeding defined as any clinically unusual bleeding meeting 1 of following criteria; a)Fatal bleeding; b) Including retroperitoneal and intracranial bleeding, or bleeding into critical organ (eye, adrenal gland, pericardium, spine); c) Reoperation due to bleeding or hematoma at operative site; d)Bleeding leading to hemoglobin (Hb) fall \> = 2 gram per deciliter (g/dL)(1.6 millimole per litre \[mmol/L\]) within 48 hour of the bleed; e)Bleeding that required transfusion of red blood cells (RBCs) or whole blood (WB) derived from \>= 900 milliliter (mL) of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) \>=2. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE.
次要结局
- Percentage of Participants With Minor Bleeding(Up to Day 17)
- Percentage of Participants With All Deep Vein Thrombosis (DVT)(Up to Day 17)
- Percentage of Participants With Proximal DVT(Up to Day 17)
- Percentage of Participants With Distal Only DVT(Up to Day 17)
- Percentage of Participants With Symptomatic DVT During Main Efficacy Period(Up to Day 17)
- Percentage of Participants With Pulmonary Embolism During Efficacy Period(Up to Day 17)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths(From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.)
- Number of Transfused Participants(Up to Day 17.)
- Volume of Transfusion(Up to Day 17)