A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdomi
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,309
- 主要终点
- venous thromboembolism (VTE)
研究概览
简要总结
This is a multicentre, randomized, double-blind, placebo controlled study. During this study all the patients will receive background venous thromboembolism (VTE) mechanical prophylaxis with intermittent pneumatic compression (IPC).
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of fondaparinux in the prevention of venous thromboembolism (VTE) in subjects undergoing abdominal surgery at increased risk for VTE. During this study all subjects were to receive background VTE prophylaxis with intermittent pnuematic compression (IPC) ± elastic stockings (ES).
Screening Period ( Day -30-Day 0) all subjects at increased risk of VTE undergoing abdominal surgery and fulfilled the study entry criteria were eligible for the study.
Treatment Period (Day 7 ±2): At the baseline assessment on the day of surgery (Day 1) subjects who satisfied all inclusion/exclusion criteria were randomized (1:1) to receive either fondaparinux or placebo. All the subjects were to receive background therapy with IPC ±ES. The first administration of either fondaparinux 2.5mg or placebo was to take place 6 to 8 hours after surgical closure provided hemostasis was achieved. Thereafter a once daily subcutaneous injection of either fondaparinux 2.5mg or placebo was to be administered up to Day 7 ±2. During the treatment phase, subjects were assessed daily. A mandatory venogram was performed between Day 5 and 10 or earlier in the case of symptomatic VTE, but not more than 1 calendar day after the last study treatment administration.
Follow up Period (Day 30 ±2): A follow-up visit or contact was to take place at Day 30 ±2 days. Use of antithrombotic therapy for prevention of VTE after the mandatory venographyand during the entire Follow-up Period was left to the investigator's discretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor) lasting longer than 45 minutes (duration from anesthesia induction to surgical closure)
- •Over 40 years of age
- •Subject who had signed the informed consent.
排除标准
- •Active, clinically significant bleeding
- •Documented congenital or acquired bleeding tendency/disorders
- •Active ulcerative gastrointestinal disease unless the reason for the present surgery.
- •Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation) brain, spinal, or ophthalmologic surgery.
- •Indwelling intrathecal or epidural catheters for more than 6 hours after surgical closure.
- •Subjects who had a traumatic puncture or unusual difficulty in applying the catheter
- •Known cerebral metastasis,
- •Subjects in whom hemostasis had not been established 6 hours after surgical closure,
- •Current thrombocytopenia,
- •Bacterial endocarditis
- •Creatinine level above 2.0 mg/dL (180 μmol/L) in a well-hydrated subject,
- •Documented hypersensitivity to contrast media,
- •Use of any contraindicated drug that could not be combined with the injection of contrast medium,
- •Patent with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings.
- •Exclusion criteria related to trial methodology:
- •Mental disorders that could interfere with study participation and/or failure to give written informed consent to take part in the study,
- •Subject's life expectancy < 6 months,
- •Clinical sign of DVT and/or history of recent DVT,
- •Participation in any other therapeutic drug study or a device study evaluating DVT prophylaxis within 90 days preceding inclusion,
- •Previous participation in a study of fondaparinux sodium,
- •Known hypersensitivity to fondaparinux and its excipients,
- •Current addictive disorders that could interfere with study participation,
- •Administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin, fibrinolytic agents or drugs blocking glycoprotein platelet receptors (GPIIb-IIIa) during the screening period, i.e., from admission to surgery,
- •Subjects for whom anticoagulant therapy was contraindicated or who had, due to concomitant disease, an indication for oral anticoagulant or heparins (including LMWH) and who could not discontinue those treatments,
- •Women of child-bearing potential: women not using an appropriate contraceptive method during the whole duration of study participation ,
- •Subject with body weight <50 kg,
- •Subjects, who in the opinion of the investigator, required a pharmacological prophylaxis in addition to intermittent pneumatic compression,
- •Known pregnancy and / or women who intended to breastfeed,
- •Subjects undergoing vascular surgery such as aorto-femoral bypass graft
研究组 & 干预措施
Placebo + intermittent pneumatic compression (IPC)
干预措施: placebo (Other)
fondaparinux + intermittent pneumatic compression (IPC)
干预措施: fondaparinux sodium (Drug)
结局指标
主要结局
venous thromboembolism (VTE)
时间窗: adjudicated mandatory venogram positive for DVT between day 5 and day 10; up to day 10 for symptomatic DVT and/or adjudicated non fatal Pe , adjudicated fatal PE
the incidence of VTE determined as any of the following VTE outcomes recorded up to the first venogram performed or up to Day 10, whichever occurred first: adjudicated manadatory veongram positive for DVT between Day 5 and Day 10; adjudicated symptomatic DVT and/or adjudicated non-fatal PE; adjudicated fatal PE
major bleeding
时间窗: first study drug injection to 2 days after last study drug injection and first study drug injection up to Day 32
adjudicated major bleeding
次要结局
- Transfusion(3 years)
- Lab parameters(3 years)
- Death(3 years)
- Adverse events(3 years)
- symptomatic VTE (venous thromboembolism)(up to Day 10 and up to Day 32)
- initiation of curative treatment(3 years)
- any VTE and all deaths(up to Day 10)
- symptomatic VTE and all deaths(up to Day 32)
- minor bleeding(treatment period and up to day 32)
- All major or minor bleeding(3 years)
- deep vein thrombosis (DVT)(up to Day 10)