A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients

• proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening, [ Time Frame: 20 days ] [ Designated as safety issue: No ]
• symptomatic DVT, [ Time Frame: 20 days ] [ Designated as safety issue: No ]
• symptomatic non-fatal pulmonary embolism (PE), [ Time Frame: 20 days ] [ Designated as safety issue: No ]
• combination of proximal DVT, non fatal PE and death from all causes including PE [ Time Frame: 20 days ] [ Designated as safety issue: No ]
• VTE related death, [ Time Frame: 20 days ] [ Designated as safety issue: No ]

• proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,
• symptomatic DVT,
• symptomatic non-fatal pulmonary embolism (PE),
• combination of proximal DVT, non fatal PE and death from all causes including PE
• VTE related death,

This study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.

• Drug: Certoparin
  3000 U anti XA of certoparin in 0.3 ml solution, once daily
  Other Names:

  • Sandoparin
  • Embolex
  • low molecular weight heparin
• Drug: Unfractionated Heparin
  solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily

• Experimental: Certoparin
  Intervention: Drug: Certoparin
• Active Comparator: Unfractionated Heparin
  Intervention: Drug: Unfractionated Heparin

• Haas S, Schellong SM, Tebbe U, Gerlach HE, Bauersachs R, Melzer N, Abletshauser C, Sieder C, Bramlage P, Riess H. Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY. BMC Cancer. 2011 Jul 26;11:316.
• Bauersachs R, Schellong SM, Haas S, Tebbe U, Gerlach HE, Abletshauser C, Sieder C, Melzer N, Bramlage P, Riess H. CERTIFY: prophylaxis of venous thromboembolism in patients with severe renal insufficiency. Thromb Haemost. 2011 Jun 6;105(6):981-8. Epub 2011 Apr 20.
• Tebbe U, Schellong SM, Haas S, Gerlach HE, Abletshauser C, Sieder C, Bramlage P, Riess H. Certoparin versus unfractionated heparin to prevent venous thromboembolic events in patients hospitalized because of heart failure: a subgroup analysis of the randomized, controlled CERTIFY study. Am Heart J. 2011 Feb;161(2):322-8.

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

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 the next 3 weeks after randomization
4. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
5. immobilization due to cast or fracture
6. indication for anticoagulatory or thrombolytic therapy
7. acute symptomatic DVT / PE
8. known hypersensitivity to any of the study drugs or drugs with similar chemical structures
9. Acute or history of heparin induced thrombocytopenia type II (HIT II)

Other protocol-defined inclusion/exclusion criteria may apply