Determination of Predictive Value of Echography Doppler Abnormalities

• Conditions: Breast Cancer; Upper Extremity Deep Vein Thrombosis, Secondary

• Registration Number: NCT00714909
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2008-07-11
• Study First Submitted QC: 2008-07-11
• Study First Posted: 2008-07-14
• Study Start: 2008-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23
• Primary Completion: 2011-11
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan	within 6 months

Trial Locations

Locations (1)

Saint-Louis Hospital; 🇫🇷 Paris, France