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Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx (ORANGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04490005
Recruitment Status : Not yet recruiting
First Posted : July 28, 2020
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
University of Lausanne
Université Libre de Bruxelles
Information provided by (Responsible Party):
University of Milano Bicocca

Brief Summary:

The use of quantitative, automated, infrared technology for pupillary examination has long been used in ophthalmology and anesthesiology research. Its interest in neurocritical care has progressively grown, in parallel with the advancements in device technology. In this regard, the use of the noninvasive NPi®-200 pupillometer (Neuroptics, Laguna Hills, California, USA) allows the measurement of a series of dynamic pupillary variables (including the percentage pupillary constriction, latency, constriction velocity, and dilation velocity), which can be integrated into an algorithm, to compute the Neurological Pupil index (NPi). The NPi is a proprietary scalar index with values between 0 and 5 (with a 0.1 decimal precision), an NPi value < 3 indicating an abnormal pupillary reactivity. Importantly, the NPi is not influenced by sedation-analgesia, at the doses used in neurocritical care practice, and by mild hypothermia.

Preliminary single-center data recently demonstrated that abnormal NPi is associated with worse outcome in patients with traumatic and hemorrhagic ABI, and can be a useful adjunct for ICP monitoring and therapy. There is currently a great need for quantitative tools to predict early prognostication in ABI patients, and the NPi appears of potential great value.

We hypothesize that:

  1. Abnormal NPi (defined as NPi <3) are strongly predictive of poor GOS-E (1-4) at 6 months after the acute event.
  2. NPi=0 is strongly predictive of mortality (GOS 1).
  3. Abnormal NPi is predictive of a higher ICP 20 index (number of end-hourly measures of ICP >20 mm Hg divided by the total number of measurements, multiplied by 100) and a greater burden of interventions needed to control ICP (measured by the Therapy Intensity Level scale for ICP management, Therapy Intensity Level (TIL) 4).

Methods This international multicentre prospective observational study aims to recruit >400 patients admitted to intensive care units.

Duration of the study 18 months, including 12-month of recruitment based on 60 patients/centre plus 6 months GOS-E follow-up.


Condition or disease Intervention/treatment
Acute Brain Injury Pupillary Reflex Impaired Other: pupillometry

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Group/Cohort Intervention/treatment
Acute brain injury

Intensive care unit (ICU) admission after ABI, including traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (SAH) and intracerebral haemorrhage (ICH)

• Age 18 years old.

Other: pupillometry
evaluation of pupillary reflex by using the Neuroptics Pupillometer every 4 hours during ICU stay




Primary Outcome Measures :
  1. Correlation between abnormal Neurological Pupil index (NPi) and long-term outcome [ Time Frame: 6 months ]
    To evaluate the association between abnormal Neurological Pupil index (NPi) and long-term outcome (6-month mortality and neurological recovery, measured with the extended Glasgow Outcome Score, GOS-E) in patients with ABI.


Secondary Outcome Measures :
  1. Correlation between intracranial hypertension and abnormal NPI values [ Time Frame: 6 months ]
    The secondary aim, in patients with ICP monitoring, is to evaluate the relationship of abnormal NPi and intracranial hypertension in order to prognosticate a poor neurological outcome (Glasgow Outcome Scale-Extended)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
No formal sample size calculation has been performed due to the exploratory nature of the study. However, we expect to recruit a total of 420 patients, 140 per pathology for whom GOSE will be performed (i.e. TBI, ICH, SAH), over a 12-months period. Therefore, the six participating centres will contribute, based on their potentiality of recruitment, with a minimum of 20 patients for each of the three pathologies, for a total of 60.
Criteria

Inclusion Criteria:

  • Intensive care unit (ICU) admission after ABI, including traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (SAH) and intracerebral haemorrhage (ICH)
  • Age > 18 years old.
  • Pupillometry available as standard evaluation tool.

Exclusion Criteria:

  • ABI not admitted to the ICU.
  • Facial trauma not allowing pupils' evaluation.
  • Age < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490005


Contacts
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Contact: Giuseppe Citerio, MD, Prof. +39 039 233 4335 giuseppe.citerio@unimib.it
Contact: Silvia Mori, Mrs +39 0264488155 bicro@unimib.it

Locations
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United States, California
Department of Neurology, University of California
San Francisco, California, United States, 94110
Contact: Claude J Hemphill, MD         
Contact: Dominica Randazzo, Mrs       Dominica.Randazzo@ucsf.edu   
Parnassus Hospital UCSF
San Francisco, California, United States, 94143
Contact: Wade Smith       Wade.Smith@ucsf.edu   
United States, Maryland
John Hopkins
Baltimore, Maryland, United States, 21218
Contact: José I. Suarez, Prof       jsuarez5@jhmi.edu   
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Contact: Randall M Chesnut, Prof    206-744-9374    chesnutr@neurosurgery.washington.edu   
Belgium
Erasme Hospital, Université Libre de Bruxelles
Brussels, Belgium
Contact: Fabio S Taccone, MD, Prof       ftaccone@ulb.ac.be   
France
Department Anesthesia and Critical Care, University Hospital
Grenoble, France
Contact: Pierre Bouzat       PBouzat@chu-grenoble.fr   
Germany
Universitätsklinikum
Erlangen, Germany
Contact: Stefan Schwab, Prof       Stefan.Schwab@uk-erlangen.de   
Contact: Joji Kuramatsu, MD       joji.kuramatsu@uk-erlangen.de   
Italy
Spedali Civili
Brescia, BS, Italy, 25121
Contact: Frank A. Rasulo, Prof       francesco.rasulo@unibs.it   
Contact: Alessandra Beretta, MD       alessandra.beretta@live.com   
Policlinico Gemelli
Roma, RM, Italy, 00168
Contact: Anselmo Caricato, MD       anselmo.caricato@policlinicogemelli.it   
Norway
Oslo Universitary Hospital
Oslo, Norway
Contact: Kjetil Sunde, Prof       kjetil.sunde@medisin.uio.no   
Contact: Anders Feyling, MD       andfeyl@ous-hf.no   
Spain
Hospital Clinic Universitari de València, University of Valencia
Valencia, Spain
Contact: Rafael Badenes, MD       rafaelbadenes@gmail.com   
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV), University Hospital and University of Lausanne
Lausanne, Switzerland
Contact: Mauro Oddo, MD, Prof       mauro.oddo@chuv.ch   
Sponsors and Collaborators
University of Milano Bicocca
University of Lausanne
Université Libre de Bruxelles
Investigators
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Principal Investigator: Giuseppe Citerio, MD, Prof University of Milano Bicocca
Publications of Results:

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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04490005    
Other Study ID Numbers: ORANGE
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to data The University of Milano-Bicocca has the property of all the data collected. The data resides at the University Milano-Bicocca as study Sponsor; all procedures will comply with the European Union (EU) regulation on data protection 2016/679 on the protection of natural persons regarding personal data processing and movement. Local site data will be co-owned by each participating centre, and they will be given access to local data for any scientific purpose upon request. By entering data into the ORANGE study database, each centre agrees that the chief can use these data for scientific purposes. Any requests for the use of the data set for subsequent studies will be made to the ORANGE study chief investigators. Any requests for the use of the data set for subsequent studies will be made to the ORANGE study chief investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Milano Bicocca:
acute brain injury
pupillometry
intracranial hypertension
neurological outcome
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System