Determination of Predictive Value of Echography Doppler Abnormalities (CAVECCAS)
Recruitment status was Recruiting
In order to avoid to use a traumatic and iatrogenic examen (phlebography), the purpose of the study is to validate echography doppler in the diagnosis of asymptomatic related catheter related thrombosis.
Upper Extremity Deep Vein Thrombosis, Secondary
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||CAVECCAS Value of Risk Factors for Symptomatic Catheter Related Thrombosis in Patients With Breast Cancer Treated With Adjuvant Chemotherapy|
- Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Phlebography is the gold standard for the diagnosis of asymptomatic catheter related thrombosis but can not be performed in about 15% of patients because of arm swelling and lack of superficial veins.
Echography doppler is an easy, cheap and atraumatic way to make the diagnosis of deep vein thrombosis. The value of echography doppler has been proven for the diagnosis of symptomatic deep venous thrombosis of lower and upper limbs and for the diagnosis of proximal asymptomatic lower limbs.
To validate the echography doppler we intend to correlate asymptomatic findings to the occurrence symptomatic related catheter related thrombosis.
Patients with localized breast cancer treated with chemotherapy will be enrolled in the study. An echography doppler will be performed on day 8, 30 and 90 after catheter insertion. Findings in asymptomatic patients (thrombus visualisation, lack of vein compressibility, variation of physiologic vein blood flow) will thereafter be correlated with the presence or absence of clinical signs of catheter related thrombosis.
In order to assess if they are risk factors for catheter related thrombosis, we will determine the level D-Dimer, microparticles and the results of generation thrombin tests before and 2 days after catheter insertion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714909
|Contact: Philippe M Debourdeau, MD||+33 1 4249 firstname.lastname@example.org|
|Paris, France, 75010|
|Contact: Philippe M Debourdeau, MD +33 1 4249 9768 email@example.com|
|Principal Investigator: Philippe M Debourdeau, MD|
|Principal Investigator:||Philippe M Debourdeau, MD||Saint-Louis Hospital, Paris, France|