Determination of Predictive Value of Echography Doppler Abnormalities

NCT ID: NCT00714909

Last Updated: 2011-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-05-31

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.

Conditions

Breast Cancer; Upper Extremity Deep Vein Thrombosis, Secondary

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of developpement

Principal Investigators

Philippe M Debourdeau, MD

Role: PRINCIPAL_INVESTIGATOR

Saint-Louis Hospital, Paris, France

Locations

Saint-Louis Hospital

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe M Debourdeau, MD

Role: CONTACT

onco.debourdeau@yahoo.fr

+33 1 4249 9768

Facility Contacts

Philippe M Debourdeau, MD

Role: primary

onco.debourdeau@yahoo.fr

+33 1 4249 9768

Other Identifiers

K070104

Identifier Type: -

Identifier Source: org_study_id