NCT01046903已完成不适用
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin® (Dalteparin Sodium) In Patients Undergoing Major Orthopedic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 503
- 主要终点
- Physician's Assessment of Efficacy of Treatment
研究概览
简要总结
The objective of this study is to observe the safety, tolerability, and compliance in the use of Fragmin® for prolonged thromboprophylaxis in post-surgery high-risk orthopedic patients.
详细描述
All patients prescribed Fragmin® (Dalteparin Sodium) for prolonged thromboprophylaxis will be eligible for study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, undergoing major orthopedic surgery
- •At least 18 years old
排除标准
- •Hypersensitivity to Fragmin or other low molecular weight heparins or unfractioned heparin;
- •History of heparin induced thrombocytopaenia type II
- •Acute gastroduodenal ulcer, cerebral haemorrhage, or other active haemorrhage.
- •Serious coagulation disorder;
- •Septic endocarditis;
- •Injuries to and operations in the central nervous system, eye and ear within one month before orthopaedic surgery;
- •Spinal or epidural anesthesia or other procedures requiring spinal puncture and concomitant treatment with high doses of dalteparin (such as those needed to treat acute deep vein thrombosis, pulmonary embolism, and Unstable coronary artery disease);
- •Patients with serum creatinine level > 150 umol/l;
- •Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy;
- •High probability that patient will not return to the centre for follow-up;
- •Patient on oral anticoagulation therapy in the last 7 days;
- •Ongoing anticoagulant therapy with other medications or non-pharmacologic therapy during the study period;
- •Weight less than 40 kg;
- •Simultaneous participation in another pharmacological study or receiving any investigational drug 30 days or less before surgery;
- •Pregnancy or breastfeeding;
- •Clinically significant hepatic dysfunction.
研究组 & 干预措施
1
干预措施: Fragmin® (Dalteparin Sodium) (Drug)
结局指标
主要结局
Physician's Assessment of Efficacy of Treatment
时间窗: Baseline up to Week 5
Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.
次要结局
未报告次要终点
研究者
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