Informations générales (source: ClinicalTrials.gov)
Tomoscintigraphie Hybride Aux Leucocytes Marqués Dans le Diagnostic Des Infections de Prothèses Vasculaires. (LEUCOPRO)
Interventional
Phase 3
University Hospital, Angers (Voir sur ClinicalTrials)
septembre 2015
janvier 2020
29 juin 2024
Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis
is often difficult (germs are found only in 50% of cases). Conventional imagery is often
non-specific and difficult to interpret especially in early postoperative phase.
Leukocytes isolated from the patient's blood are labeled with a radiopharmaceutical
technetium 99mTc-HMPAO.
The aim of this study is to assess the overall diagnostic performance of scintigraphy
(hybrid SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular
prothesis infection.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHRU - 67091 - Strasbourg - France | Nabil Chakfe | Contact (sur clinicalTrials) | |||
| CHU - 49933 - Angers - France | Hervé Rakotonirina | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH - 72037 - Le Mans - France | Helene Loubiere | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- patient of more than 18 years old
- Patient with a subdiaphragmatic vascular prosthesis
- Vascular prosthesis infection suspected with clinical (flow from the scare and/or
local pain and/or erythema and/or persistent fever and/or bacteraemia) and/or
biological (inflammatory syndrome : elevated C-reactive protein and/or erythrocyte
sedimentation rate (ESR) and/or white blood cells increased) infection signs
- Patient willing to participate with a signed informed consent
- Patient covered by a healthcare insurance
- patient of more than 18 years old
- Patient with a subdiaphragmatic vascular prosthesis
- Vascular prosthesis infection suspected with clinical (flow from the scare and/or
local pain and/or erythema and/or persistent fever and/or bacteraemia) and/or
biological (inflammatory syndrome : elevated C-reactive protein and/or erythrocyte
sedimentation rate (ESR) and/or white blood cells increased) infection signs
- Patient willing to participate with a signed informed consent
- Patient covered by a healthcare insurance
- Pregnant women or of childbearing age without effective contraception
- Prosthesis limited to a bare stent.
- Patient who has been committed to an institution by legal or regulatory order
- Contraindications for labeled leukocytes scintigraphy realization :
- Restlessness, inability to keep still lie at least 1 hour
- Claustrophobia
- Poor compliance predictable or impaired general condition making it impossible to
carry out the examination
- Refusal to participate in the study