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

NCT05100355 | Completed

• 1 other identifier: ICO-2021-07
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 9

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Medico-economic evaluation of both procedures

  3 months

• Medico-economic evaluation of both procedures

  3 months

• Medico-economic evaluation of both procedures

  3 months

• Evaluate the frequency of recurrence of lack of CVC blood return

  3 months

• Evaluate the frequency of recurrence of new re-opacification events

  3 months

Study Arms (2)

Opacification

ACTIVE COMPARATOR

Contrast agent injection

Procedure: Contrast agent injection

Physiological serum injection

EXPERIMENTAL

Physiological serum injection

Procedure: Physiological serum injection

Interventions

Physiological serum injection PROCEDURE

In case of lack of CVC blood return, Physiological serum is injected in the CVC after Chest X-Ray

Physiological serum injection

Contrast agent injection PROCEDURE

In case of lack of CVC blood return, Contrast agent is injected in the CVC after Chest X-Ray

Opacification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• PHRC-I: collaborator

Study Sites (9)

Institut de Cancérologie de l'Ouest

Angers, 49055, France

Location

Institut du Cancer Sainte Catherine Avignon Provence

Avignon, 80005, France

Location

Ch Cholet

Cholet, 49300, France

Location

CHD La Roche Sur yon

La Roche-sur-Yon, 85925, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

CH Yves Le Foll

Saint-Brieuc, 22023, France

Location

Audrey ROLLOT

Saint-Herblain, 44805, France

Location

Centre Hospitalier de St Malo

St-Malo, 35400, France

Location

CHBA Vannes

Vannes, 56017, France

Location

MeSH Terms

Interventions

Contrast Media

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 29, 2021
• Study Start: March 9, 2022
• Primary Completion: February 26, 2025
• Study Completion: June 26, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

FR (9)