- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04094155
Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage
A subarachnoid hemorrhage occurs in about 10 out of 100,000 people each year. This bleeding leads to irritation and constriction of blood vessels in the brain (vasospasm) in two out of three people affected within four to 21 days and thus to reduced blood flow. This can lead to a stroke and serious damage. In order to be able to diagnose and treat a constriction of the blood vessels at an early stage, there are various examination methods which, however, have various disadvantages such as radiation exposure of the patient, low sensitivity or high effort. Therefore, the prediction and timely therapy of vascular constrictions is currently only successful in a few cases before the reduced blood flow has already led to irreversible damage.
The aim of this study is to investigate whether the so-called retinal vascular analysis can be used in addition to previous standard examinations for the early detection of diseases of the cerebral blood circulation. This method has few side effects and has been successfully used for 50 years to examine the blood circulation in the eye.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Aachen, Allemagne, 52074
- Recrutement
- Uniklinik RWTH Aachen, Klinik für Neurochirurgie
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Contact:
- Gerrit A Schubert, Prof. Dr.
- Numéro de téléphone: +49 2418088480
- E-mail: gschubert@ukaachen.de
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Female or male patient, age ≥ 18 years
- Inpatient stay in the clinic
- Written informed consent for participation in the study prior to beginning of treatment
- Written consent for further evaluation of the images and for the scientific publication of the study results
- Non-traumatic subarachnoid haemorrhage confirmed by computer tomography or magnetic resonance tomography or cerebrospinal fluid puncture (collection of nerve water from the lower part of the lumbar spine
Exclusion Criteria:
- Female or male patient < 18 years
- Pregnancy, Lactation
- Lack of written consent to participate in the study and to further evaluate the image material collected
- Known allergy to MS eye drops (active substance: phenylephrine/tropicamide
- Narrow chamber angle, narrow angle glaucoma, Terson syndrome (if it makes retinal vascular imaging impossible
- Persons in a dependency or employment relationship with the investigator
- Persons who are accommodated in a facility by judicial or administrative order
- Receipt and intake of a study drug within the last 30 days
- Supine position in bed
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Retinal fundoscopy
Retinal vascular analysis by retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage
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Retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Clinical Progression of Delayed cortical ischemia
Délai: 21 days
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Delayed cortical ischemia as ischemia in cranial computer tomography or cranial magnetic resonance tomography that occurred later than 24 hours after admission to hospital
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21 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Occurrence of delayed ischemic neurological deficit (DIND)
Délai: 21 days
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21 days
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Angiographic vasospasm
Délai: 7 days
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Occurence of an angiographic vasospasm measured by:
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7 days
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Metabolic deficiency supply
Délai: 21 days
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Measured as change in lactate-pyruvate ratio in microdialysis
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21 days
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Metabolic deficiency supply
Délai: 21 days
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Measured as change in reduction in parenchymal oxygen partial pressure measurement
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21 days
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Relative underperfusion
Délai: 21 days
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Measured by Perfusion-Computer-Tomography
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21 days
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Objective degree of recovery
Délai: 3 Month
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Measured by Glasgow-Outcome-Scale; Scale by which patients who have experienced brain damage can be divided into 5 groups that allow to describe the degree of recovery in a standardized and objective manner (1: death; 2: vegetative condition, the patient is unresponsive.
The higher cognitive functions are extinguished; 3: severe disability, the patient is conscious, but cannot cope with normal everyday activities without help; 4: moderate disability, the patient can live largely independently, but is not able to pursue a normal working life; 5: light to no handicap, the neurological, physical, and psychological deficits are so low that the patient can participate normally in social and economic activities)
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3 Month
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gerrit A Schubert, Prof. Dr., Principal Investigator
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 14-061
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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