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Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage

Primary Purpose

Non-traumatic Subarachnoid Haemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
retinal vascular analysis
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-traumatic Subarachnoid Haemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uniklinik RWTH Aachen, Klinik für NeurochirurgieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Retinal fundoscopy

Arm Description

Retinal vascular analysis by retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Occurrence of delayed ischemic neurological deficit (DIND)
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
Metabolic deficiency supply
Measured as change in lactate-pyruvate ratio in microdialysis
Metabolic deficiency supply
Measured as change in reduction in parenchymal oxygen partial pressure measurement
Relative underperfusion
Measured by Perfusion-Computer-Tomography
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)

Full Information

First Posted
September 10, 2019
Last Updated
September 17, 2019
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT04094155
Brief Title
Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage
Official Title
Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RWTH Aachen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-traumatic Subarachnoid Haemorrhage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retinal fundoscopy
Arm Type
Experimental
Arm Description
Retinal vascular analysis by retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage
Intervention Type
Diagnostic Test
Intervention Name(s)
retinal vascular analysis
Intervention Description
Retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage
Primary Outcome Measure Information:
Title
Clinical Progression of Delayed cortical ischemia
Description
Delayed cortical ischemia as ischemia in cranial computer tomography or cranial magnetic resonance tomography that occurred later than 24 hours after admission to hospital
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Occurrence of delayed ischemic neurological deficit (DIND)
Time Frame
21 days
Title
Angiographic vasospasm
Description
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
Time Frame
7 days
Title
Metabolic deficiency supply
Description
Measured as change in lactate-pyruvate ratio in microdialysis
Time Frame
21 days
Title
Metabolic deficiency supply
Description
Measured as change in reduction in parenchymal oxygen partial pressure measurement
Time Frame
21 days
Title
Relative underperfusion
Description
Measured by Perfusion-Computer-Tomography
Time Frame
21 days
Title
Objective degree of recovery
Description
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)
Time Frame
3 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerrit A Schubert, Prof. Dr.
Phone
+492418088480
Email
gschubert@ukaachen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerrit A Schubert, Prof. Dr.
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinik RWTH Aachen, Klinik für Neurochirurgie
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerrit A Schubert, Prof. Dr.
Phone
+49 2418088480
Email
gschubert@ukaachen.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
34194387
Citation
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.
Results Reference
derived

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Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage

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