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Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Certoparin |
|
| 2 | Active Comparator | Heparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certoparin | Drug | Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment | 10 ± 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Thromboembolic events during follow-up period of 3 months | 90 days (± 7 days) after the end of the treatment | |
| Safety endpoints occurring during the treatment period: Hemorrhage (major or minor), Thrombocytopenia, Symptomatic HIT type II, Induction of HIT-II specific antibodies |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Centers | Germany | |||||
| Novartis Pharmaceuticals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20950224 | Result | Schellong SM, Haas S, Greinacher A, Schwanebeck U, Sieder C, Abletshauser C, Bramlage P, Riess H. An open-label comparison of the efficacy and safety of certoparin versus unfractionated heparin for the prevention of thromboembolic complications in acutely ill medical patients: CERTAIN. Expert Opin Pharmacother. 2010 Dec;11(18):2953-61. doi: 10.1517/14656566.2010.521498. Epub 2010 Oct 18. |
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| ID | Term |
|---|---|
| D004617 | Embolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C403769 | certoparin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Heparin | Drug | 7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days |
|
| 10 ± 2 days |
| Basel |
| Switzerland |