Comparison of Two Different Dosages of Low-molecular Weight Heparin in Cancer Patients

In a prospective, randomized, double-blind trial, the effects of two different dosages of LMWH (5000 anti-Xa U od sc and 10 000 anti-Xa U od sc daily) on markers of hemostatic system and thrombin generation will be investigated in non-surgical cancer patients will be investigated.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients (> 18 years) with active cancer and at least one of the following indications for thromboprophylaxis with LMWH:

Immobilization
History of VTE
Acute inflammation
Heart failure (NYHA class III or IV)
Respiratory failure

Exclusion criteria

Indication for LMWH or UFH at therapeutic dosages
Treatment with antithrombotics (vitamin K antagonists, acetylsalicylic acid, clopidogrel) for reasons other than prevention of VTE (e.g. atrial fibrillation, myocardial infarction)
Contraindication for the treatment with LMWH
Major surgery within the last 4 weeks; minor surgery within the last week
Thrombocytopenia (< 100.000/μl)
Prolonged prothrombin time
Prolonged activated partial thromboplastin time (aPTT)
History of heparin-induced thrombocytopenia
Bodyweight < 50 kg or > 100 kg
Renal insufficiency (creatinine > 2 mg/dl)

Treatment and study plan

Enoxaparin

Drug

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-blind Study Comparing Two Different Dosages of Low-molecular Weight Heparin

Important dates

Study start: 2006
Study completion: 2008
First posted: Sep 12, 2006
Registry last updated: Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed