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

Last updated: September 1, 2023
Sponsor: Institut Cancerologie de l'Ouest
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Physiological serum injection

Contrast agent injection

Clinical Study ID

NCT05100355
ICO-2021-07
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female or male, Age ≥ 18 years at time of study entry.
  • Undergoing systemic chemotherapy on a CVC. Immunotherapy and targeted therapies areamong 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 biologicalassessment.
  • 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

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 aniodine injection.
  • Pregnant, likely to be pregnant or breastfeeding woman.
  • Persons deprived of their liberty, under a measure of safeguard of justice, underguardianship or placed under the authority of a guardian.
  • Impossibility of undergoing medical monitoring of the trial for geographical, socialor psychological reasons, social or psychological reasons.

Study Design

Total Participants: 108
Treatment Group(s): 2
Primary Treatment: Physiological serum injection
Phase:
Study Start date:
March 09, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Institut de Cancérologie de l'Ouest

    Angers, 49055
    France

    Active - Recruiting

  • Institut du Cancer Sainte Catherine Avignon Provence

    Avignon, 80005
    France

    Terminated

  • Ch Cholet

    Cholet, 49300
    France

    Active - Recruiting

  • CHD La Roche Sur yon

    La Roche-sur-Yon, 85925
    France

    Active - Recruiting

  • Centre Eugène Marquis

    Rennes, 35042
    France

    Site Not Available

  • CH Yves Le Foll

    Saint-Brieuc, 22023
    France

    Site Not Available

  • Audrey ROLLOT

    Saint-Herblain, 44805
    France

    Active - Recruiting

  • Centre Hospitalier de St Malo

    Saint-Malo, 35400
    France

    Active - Recruiting

  • CHBA Vannes

    Vannes, 56017
    France

    Active - Recruiting

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