A observational study of efficacy and safety of medicinal drugs Dalteparin Sodium, solution for intravenous and subcutaneous administratio
- Conditions
- Health Condition 1: null- For the Treatment of thrombotic or thromboembolic complications in the postoperative period.
- Registration Number
- CTRI/2016/10/007400
- Lead Sponsor
- JSC Pharmasyntez
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 190
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Deep vein thrombosis of lower extremities, including proximal, distal, symptomatic, and asymptomaticTimepoint: ones within 14 days after surgery;
- Secondary Outcome Measures
Name Time Method Cases of all clinically significant bleedingsTimepoint: within 14 days after surgery;Cases of bleedings causing a necessity of recurrent surgical interventionTimepoint: Cases of clinically significant anemia;Cases of clinically significant anemiaTimepoint: within 14 days after surgery;Cases of major bleedingsTimepoint: within 14 days after surgery;Cases of necessities for blood transfusionTimepoint: 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 laboratoryTimepoint: During the study;Pulmonary embolism (PE)Timepoint: within 14 days after surgery