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

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

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

Study Overview

• Status: Completed
• Conditions: Catheter Dysfunction
• Intervention / Treatment: Procedure: Contrast agent injection; Procedure: Physiological serum injection

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49055
    • Institut de Cancérologie de l'Ouest
  • Avignon, France, 80005
    • Institut du Cancer Sainte Catherine Avignon Provence
  • Cholet, France, 49300
    • CH Cholet
  • La Roche-sur-Yon, France, 85925
    • CHD La Roche sur Yon
  • Rennes, France, 35042
    • Centre Eugene Marquis
  • Saint-Brieuc, France, 22023
    • CH Yves Le Foll
  • Saint-Herblain, France, 44805
    • Audrey ROLLOT
  • St-Malo, France, 35400
    • Centre Hospitalier de St Malo
  • Vannes, France, 56017
    • CHBA Vannes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Collaborators: PHRC-I

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Contrast media; Chest X-ray; Medico-economic evaluation; lack of CVC blood return; Central Venous Catheter (CVC); Day unit; Opacification; Physiological serum
• Additional Relevant MeSH Terms: Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Diagnostic Uses of Chemicals; Contrast Media
• Other Study ID Numbers: ICO-2021-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No