Management of the Lack of Blood Return on a Central Venous Catheter (CVC) Before Chemotherapy in a Day Unit: Phase III Randomised Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 9
- 主要终点
- Compare the delay between randomisation (determination of the lack of blood return) and the decision to initiate or not the chemotherapy protocol on the same day, for both procedures
研究概览
简要总结
Compare two methods of managing the lack of CVC blood return : opacification using contrast media injection or radio-clinical method with a simple chest X-ray followed by a rapid infusion of physiological serum
详细描述
The use of CVC is part of daily life in onco-hematology, particularly for chemotherapy treatments in the Day Unit (DU). Among the possible complications and dysfunctions, the most frequent is the lack of CVC blood return, which can be responsible for a disorganization of the patient's management in the Day Unit (delay in patient management).
In this study, the 2 most commonly used schemes are compared in a randomised multicentre study.
The first scheme is a radiological circuit with opacification using contrast media injection.
The second scheme is radio-clinical with a chest X-ray to check the correct functioning of the CVC followed by a rapid infusion of physiological serum.
The patient management is compared for the two schemes in term of delay (delay from start to end time of patient management). The safety and the cost of both schemes is compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male, Age ≥ 18 years at time of study entry.
- •Undergoing systemic chemotherapy on a CVC. Immunotherapy and targeted therapies are among the systemic therapies that are authorised
- •Having already received at least one administration of treatment without difficulty.
- •Coming for a new administration of treatment authorised by the usual biological assessment.
- •First episode of lack of CVC blood return despite the usual positioning and injection- aspiration manoeuvres
- •No abnormality on inspection or palpation (turning) of the CVC.
- •Patient has valid health insurance.
- •Patient information and signature of informed consent.
排除标准
- •Previous episode of lack of CVC blood return whether explored or not.
- •Patient currently treated in an interventional therapeutic trial.
- •Patient with a Picc-line implantable device.
- •Suspected CVC infection or thrombosis.
- •Planned chemotherapy with vesicant agent (anthracyclines).
- •Possible CVC disjunction.
- •Allergy to X-ray contrast agent or creatinine clearance below 30ml/min prohibiting an iodine injection.
- •Pregnant, likely to be pregnant or breastfeeding woman.
- •Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
- •Impossibility of undergoing medical monitoring of the trial for geographical, social or psychological reasons, social or psychological reasons.
研究组 & 干预措施
Opacification
Contrast agent injection
干预措施: Contrast agent injection (Procedure)
Physiological serum injection
Physiological serum injection
干预措施: Physiological serum injection (Procedure)
结局指标
主要结局
Compare the delay between randomisation (determination of the lack of blood return) and the decision to initiate or not the chemotherapy protocol on the same day, for both procedures
时间窗: 1 day
Time between randomisation and the decision to initiate or not the chemotherapy
次要结局
- Medico-economic evaluation of both procedures(3 months)
- Quantify systemic CVC infectious complications(14 days)
- Assess allergic reactions(24 hours)
- Assess the treatment delay due to CVC blood return(1 day)
- Evaluate the frequency of recurrence of lack of CVC blood return(3 months)
- Evaluate the frequency of recurrence of new re-opacification events(3 months)
- Evaluate the frequency of CVC replacement(3 months)
- Assess renal impairment(28 days)