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Completed

NCT Number: NCT05100355

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de l'Ouest, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiological serum injection

Procedure

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

Contrast agent injection

Procedure

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

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 frame: 1 day

    Time between randomisation and the decision to initiate or not the chemotherapy

Secondary outcomes

  1. Medico-economic evaluation of both procedures

    Time frame: 3 months

    Average cost of the patient management for each procedure

  2. Medico-economic evaluation of both procedures

    Time frame: 3 months

    Number of new lack of catheter blood return events

  3. Medico-economic evaluation of both procedures

    Time frame: 3 months

    Number of complications events

  4. Evaluate the frequency of recurrence of lack of CVC blood return

    Time frame: 3 months

    Number of new events of lack of CVC blood return

  5. Evaluate the frequency of recurrence of new re-opacification events

    Time frame: 3 months

    Number of new CVC re-opacification events

  6. Evaluate the frequency of CVC replacement

    Time frame: 3 months

    Number of new catheter replacements

  7. Quantify systemic CVC infectious complications

    Time frame: 14 days

    Number of Systemic CVC infectious complications

  8. Assess allergic reactions

    Time frame: 24 hours

    Number of Allergic reactions requiring at least oral therapy

  9. Assess renal impairment

    Time frame: 28 days

    Increase in creatinine to > 1.5 times the most recent screening value

  10. Assess the treatment delay due to CVC blood return

    Time frame: 1 day

    Number of CVC blood return that led to delay the treatment to the day after

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Collaborators

  • PHRC-I

Registry information

Official study title

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

Acronym: CATAREV-B

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2021
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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