acutely ill immobilized medical patients
Conditions
Interventions
Trade Name: Mono-Embolex NM Fertigspritzen
Product Name: Mono-Embolex NM
Product Code: MEX839
Pharmaceutical Form: Injection*
INN or Proposed INN: Certoparin sodium
Other descriptive name: CERTOPARIN
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospitalized medical patients 70 years of age or older 2. Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances) 3. written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. immobilization longer than 3 days prior to randomization 2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system 3. expected major surgical or invasive procedure within 3 weeks following randomization (e.g. thoracic surgery; but permitted are: e.g. uncomplicated angiography, gastroscopy) 4. patients with severe sepsis or need for ventilatory support (permitted are CPAP, oxygen via mask etc.) 5. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization 6. immobilization due to cast or fracture 7. indication for anticoagulatory or thrombolytic therapy 8. life expectancy 30%) 9. acute symptomatic DVT / PE 10. known hypersensitivity to any of the study drugs or drugs with similar chemical structures 11. Acute or history of heparin induced thrombocytopenia type II (HIT II) 12. hemorrhagic diathesis, deficiency of coagulation factors, severe thrombocytopenia 13. acute or history of non-hemorrhagic stroke ( 105 mmHg 18. severe liver disease 19. severe renal dysfunction (estimated GFR < 30 ml/min, Cockcroft-Gault or MDRD formula) 20. acute endocarditis 21. known active retinopathy, intravitreal or other intraocular bleeding 22. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 23. Subjects unlikely to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to confirm that certoparin is non-inferior in preventing the primary endpoint consisting of proximal deep vein thrombosis (DVT), symptomatic non-fatal pulmonary embolism (PE) and venous thromboembolism (VTE) related death during treatment when compared to unfractionated heparin (UFH) in acutely ill medical patients. ;Secondary Objective: The secondary objectives are to evaluate the efficacy of certoparin compared to UFH in preventing the individual components of the primary endpoint and other clinically important endpoints during treatment when compared to UFH in the study population. These endpoints are: • proximal and distal DVT (combined and separately), • symptomatic DVT, • symptomatic non-fatal PE, • combination of proximal DVT, non fatal PE and death from all causes including PE • VTE related death, • death from all causes, • documented symptomatic VTE (PE and/or DVTs, during follow up period). ;Primary end point(s): The primary efficacy endpoint is a composite endpoint occurring during treatment. The composite endpoint consists of: • proximal deep vein thrombosis • symptomatic non-fatal pulmonary embolism • venous thromboembolism related death | — |
Countries
Germany
Outcome results
None listed