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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Certoparin

Group Type EXPERIMENTAL

Certoparin

Intervention Type DRUG

Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days

2

Heparin

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days

Interventions

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Certoparin

Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days

Intervention Type DRUG

Heparin

7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No