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.

Study Overview

• Status: Unknown
• Conditions: Non-traumatic Subarachnoid Haemorrhage
• Intervention / Treatment: Diagnostic test: retinal vascular analysis

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • Uniklinik RWTH Aachen, Klinik für Neurochirurgie
    • Contact: Gerrit A Schubert, Prof. Dr.; Phone Number: +49 2418088480; Email: gschubert@ukaachen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Retinal fundoscopy; Retinal vascular analysis by retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage	Diagnostic test: retinal vascular analysis; Retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Progression of Delayed cortical ischemia	Delayed cortical ischemia as ischemia in cranial computer tomography or cranial magnetic resonance tomography that occurred later than 24 hours after admission to hospital	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of delayed ischemic neurological deficit (DIND)		21 days
Angiographic vasospasm	Occurence of an angiographic vasospasm measured by: Digital subtraction angiography at day 7 +/- 2 days or; transcranial doppler sonography: flow increase >150 cm/s absolute or increase >50 cm/s within 24 h	7 days
Metabolic deficiency supply	Measured as change in lactate-pyruvate ratio in microdialysis	21 days
Metabolic deficiency supply	Measured as change in reduction in parenchymal oxygen partial pressure measurement	21 days
Relative underperfusion	Measured by Perfusion-Computer-Tomography	21 days
Objective degree of recovery	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)	3 Month

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Gerrit A Schubert, Prof. Dr., Principal Investigator

Publications and helpful links

General Publications

• Albanna W, Conzen C, Weiss M, Seyfried K, Kotliar K, Schmidt TP, Kuerten D, Hescheler J, Bruecken A, Schmidt-Trucksass A, Neumaier F, Wiesmann M, Clusmann H, Schubert GA. Non-invasive Assessment of Neurovascular Coupling After Aneurysmal Subarachnoid Hemorrhage: A Prospective Observational Trial Using Retinal Vessel Analysis. Front Neurol. 2021 Jun 14;12:690183. doi: 10.3389/fneur.2021.690183. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: 14-061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No