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

Catheter Dysfunction Clinical Trial

— CATAREV-B  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100355
• Other study ID #: ICO-2021-07
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: Audrey ROLLOT, MD
• Phone: +33 2 40 67 99 00
• Email: audrey.rollot[@]ico.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheter Dysfunction

Intervention

Procedure:
• Physiological serum injection
In case of lack of CVC blood return, Physiological serum is injected in the CVC after Chest X-Ray
• Contrast agent injection
In case of lack of CVC blood return, Contrast agent is injected in the CVC after Chest X-Ray

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest	Angers
France	Institut du Cancer Sainte Catherine Avignon Provence	Avignon
France	Ch Cholet	Cholet
France	CHD La Roche Sur yon	La Roche-sur-Yon
France	Centre Eugène Marquis	Rennes
France	CH Yves Le Foll	Saint-Brieuc
France	Audrey ROLLOT	Saint-Herblain
France	Centre Hospitalier de St Malo	Saint-Malo
France	CHBA Vannes	Vannes

Sponsors (2)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest	PHRC-I

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Medico-economic evaluation of both procedures	Average cost of the patient management for each procedure	3 months
Secondary	Medico-economic evaluation of both procedures	Number of new lack of catheter blood return events	3 months
Secondary	Medico-economic evaluation of both procedures	Number of complications events	3 months
Secondary	Evaluate the frequency of recurrence of lack of CVC blood return	Number of new events of lack of CVC blood return	3 months
Secondary	Evaluate the frequency of recurrence of new re-opacification events	Number of new CVC re-opacification events	3 months
Secondary	Evaluate the frequency of CVC replacement	Number of new catheter replacements	3 months
Secondary	Quantify systemic CVC infectious complications	Number of Systemic CVC infectious complications	14 days
Secondary	Assess allergic reactions	Number of Allergic reactions requiring at least oral therapy	24 hours
Secondary	Assess renal impairment	Increase in creatinine to > 1.5 times the most recent screening value	28 days
Secondary	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