NCT00375076

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

First QC Date

September 11, 2006

Last Update Submit

September 17, 2009

Conditions

Cancer

Interventions

enoxaparinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Sabine Eichinger, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 12, 2006

Study Start

June 1, 2006

Study Completion

May 1, 2008

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

AU(1)