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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00311753

Enrollment

342

Registered

2006-04-06

Start date

2006-02-28

Completion date

Unknown

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolism

Keywords

heparin, thromboprophylaxis, medical patients, acutely ill, Acutely ill non surgical patients, Immobilization

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.

Interventions

DRUGCertoparin

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

DRUGHeparin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment	10 ± 2 days

Secondary

Measure	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	10 ± 2 days

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026