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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
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
Institut de Cancérologie de l'Ouest
Angers, France
Institut du Cancer Sainte Catherine Avignon Provence
Avignon, France
Ch Cholet
Cholet, France
CHD La Roche Sur yon
La Roche-sur-Yon, France
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
Time between randomisation and the decision to initiate or not the chemotherapy
Time frame: 1 day
Medico-economic evaluation of both procedures
Average cost of the patient management for each procedure
Time frame: 3 months
Medico-economic evaluation of both procedures
Number of new lack of catheter blood return events
Time frame: 3 months
Medico-economic evaluation of both procedures
Number of complications events
Time frame: 3 months
Evaluate the frequency of recurrence of lack of CVC blood return
Number of new events of lack of CVC blood return
Time frame: 3 months
Evaluate the frequency of recurrence of new re-opacification events
Number of new CVC re-opacification events
Time frame: 3 months
Evaluate the frequency of CVC replacement
Number of new catheter replacements
Time frame: 3 months
Quantify systemic CVC infectious complications
Number of Systemic CVC infectious complications
Time frame: 14 days
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Centre Eugène Marquis
Rennes, France
CH Yves Le Foll
Saint-Brieuc, France
Audrey ROLLOT
Saint-Herblain, France
Centre Hospitalier de St Malo
St-Malo, France
CHBA Vannes
Vannes, France
Assess allergic reactions
Number of Allergic reactions requiring at least oral therapy
Time frame: 24 hours
Assess renal impairment
Increase in creatinine to \> 1.5 times the most recent screening value
Time frame: 28 days
Assess the treatment delay due to CVC blood return
Number of CVC blood return that led to delay the treatment to the day after
Time frame: 1 day