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临床试验/NCT00714909
NCT00714909Unknown不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: within 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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