Catheter DysfunctionCATAREV-BNCT05100355
Management of the Lack of Blood Return on a Central Venous Catheter (CVC) Before Chemotherapy
A study testing Physiological serum injection and Contrast agent injection in people with Catheter Dysfunction, run by Institut Cancerologie de l'Ouest at 9 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Dysfunction
- What is being tested?
- Physiological serum injection and Contrast agent injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 9 sitesFrance
- Study dates
- 9 Mar 2022to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Institut de Cancérologie de l'Ouest
Angers, 49055
Institut du Cancer Sainte Catherine Avignon Provence
Avignon, 80005
Ch Cholet
Cholet, 49300
CHD La Roche Sur yon
La Roche-sur-Yon, 85925
Centre Eugène Marquis
Rennes, 35042
CH Yves Le Foll
Saint-Brieuc, 22023
Audrey ROLLOT
Saint-Herblain, 44805
Centre Hospitalier de St Malo
St-Malo, 35400
CHBA Vannes
Vannes, 56017
About this study
Official 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
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
Read the 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.
- Conditions
- Catheter Dysfunction
- Being tested
- Physiological serum injection, Contrast agent injection
- Keywords
- lack of CVC blood return, Central Venous Catheter (CVC), Day unit, Opacification, Contrast media, Medico-economic evaluation, Physiological serum, Chest X-ray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological serum injectionProcedure or surgery
In case of lack of CVC blood return, Physiological serum is injected in the CVC after Chest X-Ray
Contrast agent injectionProcedure or surgery
In case of lack of CVC blood return, Contrast agent is injected in the CVC after Chest X-Ray
| Study group | Role | What they receive |
|---|---|---|
| Opacification | Active comparator | Contrast agent injection Receives: Procedure: Contrast agent injection |
| Physiological serum injection | Experimental | Physiological serum injection Receives: Procedure: Physiological serum injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (10)
Medico-economic evaluation of both procedures
Average cost of the patient management for each procedure
Measured: 3 months
Medico-economic evaluation of both procedures
Number of new lack of catheter blood return events
Measured: 3 months
Medico-economic evaluation of both procedures
Number of complications events
Measured: 3 months
Evaluate the frequency of recurrence of lack of CVC blood return
Number of new events of lack of CVC blood return
Measured: 3 months
Evaluate the frequency of recurrence of new re-opacification events
Number of new CVC re-opacification events
Measured: 3 months
Evaluate the frequency of CVC replacement
Number of new catheter replacements
Measured: 3 months
Quantify systemic CVC infectious complications
Number of Systemic CVC infectious complications
Measured: 14 days
Assess allergic reactions
Number of Allergic reactions requiring at least oral therapy
Measured: 24 hours
Assess renal impairment
Increase in creatinine to > 1.5 times the most recent screening value
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start9 Mar 2022
- Primary completion26 Feb 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- PHRC-I
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100355
- Sponsor's protocol ID
- ICO-2021-07
- Acronym
- CATAREV-B
- Status last verified
- Nov 2025
- First submitted
- 18 Oct 2021
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05100355
- Acronym / sponsor ID
- CATAREV-B / ICO-2021-07
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- PHRC-I
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opacification | Active comparator | Procedure: Contrast agent injectionContrast agent injection |
| Physiological serum injection | Experimental | Procedure: Physiological serum injectionPhysiological serum injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological serum injectionIn case of lack of CVC blood return, Physiological serum is injected in the CVC after Chest X-Ray | Procedure or surgery | Physiological serum injection |
| Contrast agent injectionIn case of lack of CVC blood return, Contrast agent is injected in the CVC after Chest X-Ray | Procedure or surgery | Opacification |
Primary outcome
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
10 secondary outcomes
Medico-economic evaluation of both procedures
Time frame: 3 months
Medico-economic evaluation of both procedures
Time frame: 3 months
Medico-economic evaluation of both procedures
Time frame: 3 months
Evaluate the frequency of recurrence of lack of CVC blood return
Time frame: 3 months
Evaluate the frequency of recurrence of new re-opacification events
Time frame: 3 months
Evaluate the frequency of CVC replacement
Time frame: 3 months
Quantify systemic CVC infectious complications
Time frame: 14 days
Assess allergic reactions
Time frame: 24 hours
Assess renal impairment
Time frame: 28 days
Assess the treatment delay due to CVC blood return
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiological serum injection and Contrast agent injection in people with Catheter Dysfunction, run by Institut Cancerologie de l'Ouest at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.