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Study on Thrombosis Therapy in German Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01559883
First received: March 1, 2012
Last updated: October 4, 2012
Last verified: October 2012
History of Changes
  Purpose

The study aims to document the flow of German patients with cancer and acute deep vein thrombosis from first visit to diagnosis and treatment, the applied diagnostic procedures, and therapy modalities.


Condition Intervention
Cancer
Deep Vein Thrombosis
Pulmonary Embolism
 Other: no intervention is being made

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Thrombosis Therapy in German Cancer Patients

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • treatment time on low molecular weight heparin [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient pathways [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    data collection on patient pathway: who is the referring physician, physician who diagnoses deep vein thrombosis (DVT)

  • risk factors for DVT [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
all eligible patients
there is only 1 Cohort in which all patients participating in this NIS are included
 Other: no intervention is being made
This is a Non-Interventional Study (NIS)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cancer patient with acute deep vein throbosis/ pulmonary embolism in ambulatory oncology care/practice

Criteria

Inclusion Criteria:

  • patient with cancer and acute deep vein thrombosis and/or pulmonary embolism

Exclusion Criteria:

  • life expectancy less that 6 months
  • age less that 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559883

Locations
Germany
Prof. Dr. Axel Matzdorff
Saarbrücken, Saarland, Germany, 66111
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Axel Matzdorff, Prof.Dr. Caritasklinikum Saarbrücken, St. Theresia
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01559883     History of Changes
Other Study ID Numbers: DE-Thrombose-NIS-2012
Study First Received: March 1, 2012
Last Updated: October 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by LEO Pharma:
cancer
thrombosis
pulmonary embolism
anticoagulation
low molecular weight heparin

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
 Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013