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Determination of Predictive Value of Echography Doppler Abnormalities

CAVECCAS Value of Risk Factors for Symptomatic Catheter Related Thrombosis in Patients With Breast Cancer Treated With Adjuvant Chemotherapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00714909
Acronym
CAVECCAS
Enrollment
600
Registered
2008-07-14
Start date
2008-11-30
Completion date
2012-05-31
Last updated
2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Upper Extremity Deep Vein Thrombosis, Secondary

Keywords

Breast cancer, Catheter related thrombosis, Diagnosis, Echography doppler, Risk factors

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* women over 18 * histologically proven breast cancer * localized breast cancer without metastasis * adjuvant or neo adjuvant chemotherapy * insertion of central catheter with port for chemotherapy * central catheter for more than three months * inform consent * follow up for three months

Exclusion criteria

* ongoing anticoagulant therapy * previous central catheter * femoral catheter * double lumen catheter * central catheter without port * platelets \< 80G/L, TQ \< 50%, fibrinogen \< 1 g/L * creatinin \> 175mole/L

Design outcomes

Primary

MeasureTime frame
Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scanwithin 6 months

Countries

France

Contacts

Primary ContactPhilippe M Debourdeau, MD
onco.debourdeau@yahoo.fr+33 1 4249 9768

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026