National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients

Completed

• Conditions: Venous Thromboembolism; Neoplasms

• Registration Number: NCT01362933
• Lead Sponsor: Floralis

Brief Summary

Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-25
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-06-01
• Primary Completion: 2012-01
• Study Completion: 2012-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

All patients with cancer present in the clinic, hospital, out patients diagnosed with a VTE during the 6 previous months. VTE can be symptomatic or asymptomatic, can be located close to a central line, and of any type (DVT, PE, SVT)

Exclusion Criteria

• Patient already included in a trial studying antithrombotic therapy
• Patient refusing the study
• Patient under 18 and/or not competent to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the adherence to recommendations of VTE treatment in cancer patients	At baseline (J0)	Proportion of patients treated for evolutive VTE according to international recommandations Patients could be hospitalised or could be out patient

Secondary Outcome Measures

Name	Time	Method
Proportion of asymptomatic VTE disease for this population	At baseline (J0)	percentage of VTE and cancer status (local, metastatic)
Evaluation of VTE disease according to cancer diagnosis (proportion of SVT (Superficial Venous Thrombosis), DVT (Deep Venous Thrombosis), PE (Pulmonary Embolism)	At baseline (J0)	Percentage of VTE (PE,DVT,SVT)and cancer type
Feasibility of self injections for VTE treatment in cancer patients.	At baseline (J0)	percentage of patients practising self injections
Proportion of patients with catheter thrombosis	At baseline (J0)	Percentage of patients receiving novel cancer therapies

Trial Locations

Locations (48)

CHR Annecy; 🇫🇷 Annecy, France

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil, France

CH AUCH; 🇫🇷 Auch, France

CH Beauvais; 🇫🇷 Beauvais, France

Institut Bergonie; 🇫🇷 Bordeaux, France

CHU de Brest; 🇫🇷 Brest, France

CHU de Caen; 🇫🇷 Caen, France

Centre François Baclesse; 🇫🇷 Caen, France

CH Antoine Gayraud Cedex 9; 🇫🇷 Carcassonne, France

Clinique du Parc CASTELNAU LE LEZ; 🇫🇷 Castelnau Le Lez, France

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