Fragmin Safety And Efficacy In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism And Extended Thromboprophylaxis In Cancer Patients In Slovakia (An Open, Prospective, Non-Comparative Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 102
- 主要终点
- Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
研究概览
简要总结
To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.
详细描述
Method: consecutive patient sampling. Patients were (are) included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient of 18 - 70 years of age.
- •Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation scan of the lung.
排除标准
- •Hypersensitivity to FRAGMIN® or other low-molecular weight heparins.
- •Serum creatinine level > 150 umol/l.
- •Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy.
- •Patient on oral anticoagulation therapy in the last 7 days.
研究组 & 干预措施
One cohort of patients treated with dalteparin.
About 100 patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study.
干预措施: Fragmin (dalteparin sodium ) (Drug)
结局指标
主要结局
Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
时间窗: Month 6 or End of Treatment (EOT) (up to Month 6)
Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg
次要结局
- Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood(Baseline through Month 6 or EOT (up to Month 6))
- Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)(Baseline through Month 6 or EOT (up to Month 6))
- Percent of Participants With and Without Pulmonary Embolism (PE)(Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6))
- Number of Participants With Recurrent DVT(Month 6 or EOT (up to Month 6))