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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00210197
Other study ID # IB2005-06
Secondary ID EHC
Status Completed
Phase N/A
First received September 13, 2005
Last updated July 25, 2013
Start date January 2005
Est. completion date January 2006

Study information

Verified date October 2007
Source Institut Bergonié
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

The risk of deep venous thrombosis after radical breast surgery is known. The objective of this study is to explore hypercoagulability after radical breast cancer surgery by studying several factors for haemostasis before, during and after surgery. Ultrasound Doppler examination is realised between 24 and 72 hours post-operatively. Hypercoagulability is defined by a significant increasing level of thrombin-antithrombin, D-dimer and the endogen thrombin potential.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria:

- Breast cancer

- mastectomy

Exclusion criteria:

- thrombophilia

- anticoagulant treatment

Study Design

Time Perspective: Prospective


Intervention

Procedure:
Blood collection (pre and postoperative): plasma coagulation parameters


Locations

Country Name City State
France Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

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