Non-traumatic Subarachnoid HaemorrhageNCT04094155
Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage
A study testing retinal vascular analysis in people with Non-traumatic Subarachnoid Haemorrhage, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-traumatic Subarachnoid Haemorrhage
- What is being tested?
- retinal vascular analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2015to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Uniklinik RWTH Aachen, Klinik für Neurochirurgie
Aachen, 52074
Gerrit A Schubert, Prof. Dr., +49 2418088480, gschubert@ukaachen.de
About this study
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.
- Conditions
- Non-traumatic Subarachnoid Haemorrhage
- Being tested
- retinal vascular analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retinal vascular analysisDiagnostic test
Retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage
| Study group | Role | What they receive |
|---|---|---|
| Retinal fundoscopy | Experimental | Retinal vascular analysis by retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage Receives: Diagnostic Test: retinal vascular analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days
Secondary outcomes (6)
Occurrence of delayed ischemic neurological deficit (DIND)
Measured: 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
Measured: 7 days
Metabolic deficiency supply
Measured as change in lactate-pyruvate ratio in microdialysis
Measured: 21 days
Metabolic deficiency supply
Measured as change in reduction in parenchymal oxygen partial pressure measurement
Measured: 21 days
Relative underperfusion
Measured by Perfusion-Computer-Tomography
Measured: 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)
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Jul 2015
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-traumatic Subarachnoid HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerrit Alexander Schubert, RWTH Aachen University
- Investigators
- Gerrit A Schubert, Prof. Dr., Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094155
- Sponsor's protocol ID
- 14-061
- Status last verified
- Sep 2019
- First submitted
- 10 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34194387
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage
- ClinicalTrials.gov ID
- NCT04094155
- Acronym / sponsor ID
- 14-061
- Conditions
- Non-traumatic Subarachnoid Haemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal fundoscopy | Experimental | Diagnostic Test: retinal vascular analysisRetinal vascular analysis by retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retinal vascular analysisRetinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage | Diagnostic test | Retinal fundoscopy |
Primary outcome
Clinical Progression of Delayed cortical ischemia
Time frame: 21 days
Delayed cortical ischemia as ischemia in cranial computer tomography or cranial magnetic resonance tomography that occurred later than 24 hours after admission to hospital
6 secondary outcomes
Occurrence of delayed ischemic neurological deficit (DIND)
Time frame: 21 days
Angiographic vasospasm
Time frame: 7 days
Metabolic deficiency supply
Time frame: 21 days
Metabolic deficiency supply
Time frame: 21 days
Relative underperfusion
Time frame: 21 days
Objective degree of recovery
Time frame: 3 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Derived from this study: PubMed 34194387Albanna 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.
Related trials for Non-traumatic Subarachnoid Haemorrhage
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Incidence, Characteristics and Evolution of Cerebral Vasospasm With Clinical Impact in Moderate to Severe Traumatic Brain Injury Complicated by Subarachnoid Hemorrhage at Martinique University Hospital
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerrit A Schubert, Prof. Dr. principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retinal vascular analysis in people with Non-traumatic Subarachnoid Haemorrhage, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerrit A Schubert, Prof. Dr. (+492418088480, gschubert@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Progression of Delayed cortical ischemia (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.