Comparison of Two Different Dosages of Low-Molecular Weight Heparin in Cancer Patients - Full Text View

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

This study is currently recruiting participants.
Verified by Medical University of Vienna, April 2007

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00375076

Purpose

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.

Condition	Intervention	Phase
Cancer	Drug: enoxaparin	Phase III

MedlinePlus related topics:

Blood Thinners Cancer

Drug Information available for:

Heparin Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Dose Comparison, Parallel Assignment

Official Title:	Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-Blind Study Comparing Two Different Dosages of Low-Molecular Weight Heparin

Further study details as provided by Medical University of Vienna:

Study Start Date:

June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375076

Locations


Austria
	Medical University of Vienna	Recruiting
	Vienna, Austria, 1090
	Contact: Sabine Eichinger, MD +43-1-40400 ext 4410 sabine.eichinger@meduniwien.ac.at

Sponsors and Collaborators

Medical University of Vienna

Investigators


Principal Investigator:	Sabine Eichinger, MD	Medical University of Vienna

More Information

Study ID Numbers:	ODEXA1
First Received:	September 11, 2006
Last Updated:	April 19, 2007
ClinicalTrials.gov Identifier:	NCT00375076
Health Authority:	Austria: Federal Ministry for Health and Women

Study placed in the following topic categories:

Body Weight

Heparin, Low-Molecular-Weight

Venous Thrombosis

Heparin

Thrombosis

Enoxaparin

Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008