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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Management of the Lack of Blood Return on a Central Venous Catheter (CVC) Before Chemotherapy in a Day Unit: Phase III Randomised Multicentre Study

Conditions
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Catheter Dysfunction

Intervention / Treatment
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* Procedure: Physiological serum injection
* Procedure: Contrast agent injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opacification<br>Contrast agent injection | Procedure: Contrast agent injection<br>* In case of lack of CVC blood return, Contrast agent is injected in the CVC after Chest X-Ray<br>|
| Experimental: Physiological serum injection<br>Physiological serum injection | Procedure: Physiological serum injection<br>* In case of lack of CVC blood return, Physiological serum is injected in the CVC after Chest X-Ray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medico-economic evaluation of both procedures | Average cost of the patient management for each procedure | 3 months | 
| Medico-economic evaluation of both procedures | Number of new lack of catheter blood return events | 3 months | 
| Medico-economic evaluation of both procedures | Number of complications events | 3 months | 
| Evaluate the frequency of recurrence of lack of CVC blood return | Number of new events of lack of CVC blood return | 3 months | 
| Evaluate the frequency of recurrence of new re-opacification events | Number of new CVC re-opacification events | 3 months | 
| Evaluate the frequency of CVC replacement | Number of new catheter replacements | 3 months | 
| Quantify systemic CVC infectious complications | Number of Systemic CVC infectious complications | 14 days | 
| Assess allergic reactions | Number of Allergic reactions requiring at least oral therapy | 24 hours | 
| Assess renal impairment | Increase in creatinine to > 1.5 times the most recent screening value | 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 | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lack of CVC blood return, Central Venous Catheter (CVC), Day unit, Opacification, Contrast media, Medico-economic evaluation, Physiological serum, Chest X-ray