Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients

Novartis

Status and phase

Completed

Phase 3

Conditions

Embolism

Treatments

Drug: Heparin

Drug: Certoparin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00311753

CMEX839BDE02

Details and patient eligibility

About

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.

Enrollment

342 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Hospitalization due to an acute non-surgical disease
Significant decrease in mobility

Exclusion criteria

Indication for anticoagulant or thrombolytic therapy
Major surgical or invasive procedure within the 4 weeks that precede randomization
Expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization
Immobilization due to cast or fracture of lower extremity
Immobilization lasting longer than 3 days in the period prior to randomization
Heparin administration longer than 36 hours in the period prior to randomization
Acute ischemic stroke

Other protocol-defined inclusion/exclusion criteria may apply