Non-traumatic Subarachnoid Haemorrhage Clinical Trial
Official title:
Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage
| NCT number | NCT04094155 |
| Other study ID # | 14-061 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 1, 2015 |
| Est. completion date | January 1, 2021 |
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | January 1, 2021 |
| Est. primary completion date | January 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Uniklinik RWTH Aachen, Klinik für Neurochirurgie | Aachen |
| Lead Sponsor | Collaborator |
|---|---|
| RWTH Aachen University |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Occurrence of delayed ischemic neurological deficit (DIND) | 21 days | ||
| Secondary | 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 | |
| Secondary | Metabolic deficiency supply | Measured as change in lactate-pyruvate ratio in microdialysis | 21 days | |
| Secondary | Metabolic deficiency supply | Measured as change in reduction in parenchymal oxygen partial pressure measurement | 21 days | |
| Secondary | Relative underperfusion | Measured by Perfusion-Computer-Tomography | 21 days | |
| Secondary | 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 |