Clinical trial NCT00311753: Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients
Official title: An Open-label Comparison of the Efficacy and Safety of the Low-molecular-weight Heparin (3000 U Anti-Xa Once Daily) With Unfractionated Heparin for the Prevention of Thromboembolic Complications in Acutely Ill Non-surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Embolism
Keywords: heparin, thromboprophylaxis, medical patients, acutely ill
Acutely ill non surgical patients
Immobilization
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-04-06
Enrollment: 342
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment
timeFrame: 10 ± 2 days
Secondary outcomes:
measure: Thromboembolic events during follow-up period of 3 months
timeFrame: 90 days (± 7 days) after the end of the treatment
measure: Safety endpoints occurring during the treatment period: Hemorrhage (major or minor), Thrombocytopenia, Symptomatic HIT type II, Induction of HIT-II specific antibodies
timeFrame: 10 ± 2 days
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.