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 FragminÂ®, 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.â??

JSC Pharmasyntez0 个研究点目标入组 190 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Informed consent signed by the patient before beginning any procedures.
•2. Patients aged from 18 to 70 years old inclusive of both genders.
•3. Planned surgical intervention for knee or hip joint endoprothesis replacement. Operational intervention with spinal or epidural anesthesia without epidural or peridural catheter.
•4. Negative pregnancy test result for female patients.
•5. Consent of fertile female and male patients to use barrier metho

•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.

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