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

A Randomized, Double-blind, Multi-center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00451412

Enrollment

3254

Registered

2007-03-23

Start date

2007-01-31

Completion date

2009-06-30

Last updated

2012-07-25

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

Conditions

Thromboembolism

Keywords

Venous thromboembolism, Medical patients, Heparin, Low molecular weight heparin, Deep vein thrombosis, Certoparin, Embolism and Thrombosis

Brief summary

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

Interventions

DRUGCertoparin

3000 U anti XA of certoparin in 0.3 ml solution, once daily

DRUGUnfractionated Heparin

solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)	20 days

Secondary

Measure	Time frame
proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,	20 days
symptomatic DVT,	20 days
symptomatic non-fatal pulmonary embolism (PE),	20 days
combination of proximal DVT, non fatal PE and death from all causes including PE	20 days
VTE related death,	20 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026