FindTrial
Sign In

A observational study of efficacy and safety of medicinal drugs Dalteparin Sodium, solution for intravenous and subcutaneous administration

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.â??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/10/007400
Enrollment
190
Registered
2016-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- For the Treatment of thrombotic or thromboembolic complications in the postoperative period.

Interventions

Intervention1: Dalteparin Sodium 5000 anti-Xa IU: Dosage form Solution for intravenous and subcutaneous administration Control Intervention1: Fragmin 5000 (anti-Xa) IU: Dosage Form Solution for intrav

Sponsors

JSC Pharmasyntez
Lead Sponsor
NEXUS CLINICAL RESEARCH INDIA LTD
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Deep vein thrombosis of lower extremities, including proximal, distal, symptomatic, and asymptomaticTimepoint: ones within 14 days after surgery;—

Secondary

MeasureTime frame
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—

Countries

India, Russian Federation

Contacts

Public ContactDr Mangesh khadakban

Nexus Clinical Research (India) Ltd.

hbo@nexuscro.com9167243914

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026