Comparing methods to manage blood return issues in central venous catheters before chemotherapy
Management of the Lack of Blood Return on a Central Venous Catheter (CVC) Before Chemotherapy in a Day Unit: Phase III Randomised Multicentre Study
This study is testing two different ways to fix blood return problems in central venous catheters for patients getting chemotherapy to see which method works better and is safer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Cancerologie de l'Ouest Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 9 sites (Angers and 8 other locations) |
| Trial ID | NCT05100355 on ClinicalTrials.gov |
What this trial studies
This study compares two methods for addressing the lack of blood return from central venous catheters (CVC) in patients undergoing chemotherapy. One method involves the use of contrast media injection for opacification, while the other utilizes a chest X-ray followed by a rapid infusion of physiological serum. The study is designed as a randomized multicenter trial, focusing on the efficiency of patient management by measuring delays in treatment initiation and completion. Additionally, it evaluates the safety and cost-effectiveness of both approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing systemic chemotherapy via a CVC and have experienced their first episode of lack of blood return.
Not a fit: Patients with a history of previous blood return issues, suspected CVC infections, or those involved in other interventional trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could streamline the management of patients with CVC blood return issues, reducing delays in chemotherapy administration.
How similar studies have performed: While this approach is common in clinical practice, the specific comparison of these two methods in a randomized setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Angers and 8 other locations
- Institut de Cancérologie de l'Ouest — Angers, France (Recruiting)
- Institut du Cancer Sainte Catherine Avignon Provence — Avignon, France (Terminated)
- Ch Cholet — Cholet, France (Recruiting)
- CHD La Roche Sur yon — La Roche-sur-Yon, France (Recruiting)
- Centre Eugène Marquis — Rennes, France (Not_yet_recruiting)
- CH Yves Le Foll — Saint-Brieuc, France (Active_not_recruiting)
- Audrey ROLLOT — Saint-Herblain, France (Recruiting)
- Centre Hospitalier de St Malo — Saint-Malo, France (Recruiting)
- CHBA Vannes — Vannes, France (Recruiting)
Study contacts
- Study coordinator: Audrey ROLLOT, MD
- Email: audrey.rollot@ico.unicancer.fr
- Phone: +33 2 40 67 99 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.