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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2025-06-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Central Venous Catheter-related Complications in Patients Under Anticancer Treatment

NCT05455866

Central Venous Catheter Thrombosis Central Venous Catheter Related Bloodstream Infection Solid Tumor +1 more

UNKNOWN

Complications and Risk Factors Related With Central Venous Catheters in Cancer Patients

NCT01661218

Thrombosis Infections

COMPLETED

Maintenance Optimization of the Fully Implanted Venous Catheter

NCT05411666

Cancer

RECRUITING NA

Autopsy and Photon Counting Computed Tomography to Evaluate Thromboses Related to Central Venous Catheters

NCT06417541

Central Venous Catheter Thrombosis

RECRUITING

EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE)TELEHEALTH HOME MEDICATION VS/OUTPATIENT MEDICATION OF CENTRAL VENOUS CATHETER PICC (PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER)

NCT05880420

Infections

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Catheter Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Opacification

Contrast agent injection

Group Type ACTIVE_COMPARATOR

Contrast agent injection

Intervention Type PROCEDURE

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

Physiological serum injection

Group Type EXPERIMENTAL

Physiological serum injection

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physiological serum injection

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

Intervention Type PROCEDURE

Contrast agent injection

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No