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| Name | Class |
|---|---|
| PHRC-I | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opacification | Active Comparator | Contrast agent injection |
|
| Physiological serum injection | Experimental | Physiological serum injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiological serum injection | Procedure | In case of lack of CVC blood return, Physiological serum is injected in the CVC after Chest X-Ray |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Medico-economic evaluation of both procedures | Average cost of the patient management for each procedure | 3 months |
| Medico-economic evaluation of both procedures | Number of new lack of catheter blood return events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest | Angers | 49055 | France | |||
| Institut du Cancer Sainte Catherine Avignon Provence |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2026 | |
| Reset | Jun 22, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 22, 2026 |
| ID | Term |
|---|---|
| D003287 | Contrast Media |
| ID | Term |
|---|---|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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| Contrast agent injection | Procedure | In case of lack of CVC blood return, Contrast agent is injected in the CVC after Chest X-Ray |
|
| 3 months |
| Medico-economic evaluation of both procedures | Number of complications events | 3 months |
| Evaluate the frequency of recurrence of lack of CVC blood return | Number of new events of lack of CVC blood return | 3 months |
| Evaluate the frequency of recurrence of new re-opacification events | Number of new CVC re-opacification events | 3 months |
| Evaluate the frequency of CVC replacement | Number of new catheter replacements | 3 months |
| Quantify systemic CVC infectious complications | Number of Systemic CVC infectious complications | 14 days |
| Assess allergic reactions | Number of Allergic reactions requiring at least oral therapy | 24 hours |
| Assess renal impairment | Increase in creatinine to > 1.5 times the most recent screening value | 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 | 1 day |
| Avignon |
| 80005 |
| France |
| Ch Cholet | Cholet | 49300 | France |
| CHD La Roche Sur yon | La Roche-sur-Yon | 85925 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| CH Yves Le Foll | Saint-Brieuc | 22023 | France |
| Audrey ROLLOT | Saint-Herblain | 44805 | France |
| Centre Hospitalier de St Malo | St-Malo | 35400 | France |
| CHBA Vannes | Vannes | 56017 | France |