Management of the Lack of Blood Return on a Central Venous Catheter (CVC) Before Chemotherapy (CATAREV-B)

Institut Cancerologie de l'Ouest

Status: Completed

Conditions: Catheter Dysfunction

Treatments: Procedure: Contrast agent injection; Procedure: Physiological serum injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05100355

ICO-2021-07

Details and patient eligibility

About

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

Full description

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Opacification

Active Comparator group

Description:

Contrast agent injection

Treatment:

Procedure: Contrast agent injection

Physiological serum injection

Experimental group

Description:

Physiological serum injection

Treatment:

Procedure: Physiological serum injection