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

18 Years
80 Years
Open (Enrolling)
Breast Cancer, Upper Extremity Deep Vein Thrombosis, Secondary

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan

Outcome Time Frame:

within 6 months

Safety Issue:


Principal Investigator

Philippe M Debourdeau, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint-Louis Hospital, Paris, France


France: Ministry of Health

Study ID:




Start Date:

November 2008

Completion Date:

May 2012

Related Keywords:

  • Breast Cancer
  • Upper Extremity Deep Vein Thrombosis, Secondary
  • Breast cancer
  • Catheter related thrombosis
  • Diagnosis
  • Echography doppler
  • Risk factors
  • Breast Neoplasms
  • Thrombosis
  • Venous Thrombosis
  • Upper Extremity Deep Vein Thrombosis