Clinical trial NCT05100355: Management of the Lack of Blood Return on a Central Venous Catheter (CVC) Before Chemotherapy
Official title: Management of the Lack of Blood Return on a Central Venous Catheter (CVC) Before Chemotherapy in a Day Unit: Phase III Randomised Multicentre Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Catheter Dysfunction
Keywords: lack of CVC blood return
Central Venous Catheter (CVC)
Day unit
Opacification
Contrast media
Medico-economic evaluation
Physiological serum
Chest X-ray
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: PHRC-I
First posted: 2021-10-29
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 1 day
Secondary outcomes:
measure: Medico-economic evaluation of both procedures
timeFrame: 3 months
measure: Medico-economic evaluation of both procedures
timeFrame: 3 months
measure: Medico-economic evaluation of both procedures
timeFrame: 3 months
measure: Evaluate the frequency of recurrence of lack of CVC blood return
timeFrame: 3 months
measure: Evaluate the frequency of recurrence of new re-opacification events
timeFrame: 3 months
measure: Evaluate the frequency of CVC replacement
timeFrame: 3 months
measure: Quantify systemic CVC infectious complications
timeFrame: 14 days
measure: Assess allergic reactions
timeFrame: 24 hours
measure: Assess renal impairment
timeFrame: 28 days
measure: Assess the treatment delay due to CVC blood return
timeFrame: 1 day
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Avignon
country: France
facility: Institut du Cancer Sainte Catherine Avignon Provence
city: Cholet
country: France
facility: Ch Cholet
city: La Roche-sur-Yon
country: France
facility: CHD La Roche Sur yon
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Brieuc
country: France
facility: CH Yves Le Foll
city: Saint-Herblain
country: France
facility: Audrey ROLLOT
city: Saint-Malo
country: France
facility: Centre Hospitalier de St Malo
city: Vannes
country: France
facility: CHBA Vannes
Study officials:
References: