International, multicenter, randomized, open-label comparative study of efficacy and safety of medicinal drugs Dalteparin Sodium, solution for intravenous and subcutaneous administration 5000 anti-Xa IU/0.2 ml and Fragmin®, solution for intravenous and subcutaneous administration 500 anti-Xa IU/0.2 ml in patients undergoing surgery for endprosthesis replacement of large joints of the lower extremities, with a high risk of thrombotic or thromboembolic complications in the postoperative period.‖
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Deep vein thrombosis of lower extremities, including proximal, distal, symptomatic, and asymptomatic
研究概览
简要总结
Open-label, multicenter, randomized, comparative study in parallel groups
Group I will be administered Dalteparin Sodium, solution for intravenous and subcutaneous administration 5 000 anti-Xa IU/0.2 ml ("Camus Pharma Pvt. Ltd.", India) subcutaneously in a dose of 5000 IU in the evening before the day of surgery, then 5000 IU every evening after the surgery. Therapy will last for 12-14 days (including the day of surgery) depending on regular procedure of the clinical site.
Group II will be administered Fragmin®, solution for intravenous and subcutaneous administration 5000 anti-Xa IU/0.2 ml ("Pfizer MFG. Belgium N.V.", Belgium) subcutaneously in a dose of 5000 IU in the evening before the surgery, then 5000 IU every evening after the surgery. Therapy will last for 12-14 days (including the day of surgery), depending on regular procedure of the clinical site.
Intermediate visit to evaluate tolerability and safety of study therapy will be performed after 5 days ± 2 days.
Evaluation of therapy efficacy and safety will be performed after 14 ± 2 days of therapy, then depending on Investigator‘s conclusion, a patient will be discharged from the hospital and will be administered oral forms of anticoagulants as per the standard practice of clinical site (oral forms of anticoagulants approved in the RF: warfarin, dabigatran, rivaroxaban). If patient‘s condition is not acceptable for outpatient treatment, his hospitalization may be prolonged.
Test drug and reference drug are administered subcutaneously, injection sites should be changed daily (contralateral injections every next day of treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Informed consent signed by the patient before beginning any procedures.
- •Patients aged from 18 to 70 years old inclusive of both genders.
- •Planned surgical intervention for knee or hip joint endoprothesis replacement.
- •Operational intervention with spinal or epidural anesthesia without epidural or peridural catheter.
- •Negative pregnancy test result for female patients.
- •Consent of fertile female and male patients to use barrier metho.
排除标准
- •1 Patients hypersensitive to Dalteparin Sodium, heparin sodium or its compounds, including other low-molecular heparins.
- •2 Women weighing under 45 kg and men under 57 kg.
- •3 Patients having diseases with high risk of bleeding (hemorrhagic stroke, cerebral aneurysm or aortic dissection, uncontrolled bleeding) in history.
- •4 History of verified or suspected Dalteparin- or heparin-induced thrombocytopenia 5 Acute coronary syndrome, ACF.
结局指标
主要结局
Deep vein thrombosis of lower extremities, including proximal, distal, symptomatic, and asymptomatic
时间窗: ones within 14 days after surgery;
次要结局
- Cases of major bleedings(within 14 days after surgery)
- Cases of all clinically significant bleedings(within 14 days after surgery)
- Cases of bleedings causing a necessity of recurrent surgical intervention(Cases of clinically significant anemia)
- Cases of clinically significant anemia(within 14 days after surgery)
- Pulmonary embolism (PE)(within 14 days after surgery)
- Cases of necessities for blood transfusion(within 14 days after surgery)
- Incidence of other adverse events, to some extent related to the administered test drug or reference drug, including the ones evaluated on the results of laboratory(During the study)