Physiological serum injection
ProcedureIn case of lack of CVC blood return, Physiological serum is injected in the CVC after Chest X-Ray
NCT Number: NCT05100355
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Institut de Cancérologie de l'Ouest, Angers, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In case of lack of CVC blood return, Physiological serum is injected in the CVC after Chest X-Ray
In case of lack of CVC blood return, Contrast agent is injected in the CVC after Chest X-Ray
Time frame: 1 day
Time between randomisation and the decision to initiate or not the chemotherapy
Time frame: 3 months
Average cost of the patient management for each procedure
Time frame: 3 months
Number of new lack of catheter blood return events
Time frame: 3 months
Number of complications events
Time frame: 3 months
Number of new events of lack of CVC blood return
Time frame: 3 months
Number of new CVC re-opacification events
Time frame: 3 months
Number of new catheter replacements
Time frame: 14 days
Number of Systemic CVC infectious complications
Time frame: 24 hours
Number of Allergic reactions requiring at least oral therapy
Time frame: 28 days
Increase in creatinine to > 1.5 times the most recent screening value
Time frame: 1 day
Number of CVC blood return that led to delay the treatment to the day after
Institut Cancerologie de l'Ouest
Other
Management of the Lack of Blood Return on a Central Venous Catheter (CVC) Before Chemotherapy in a Day Unit: Phase III Randomised Multicentre Study
Acronym: CATAREV-B
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