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

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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enoxaparin

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No