CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe (CREACTIVE)

March 15, 2022 updated by: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI) care in the ICU setting

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Traumatic brain injury (TBI) is among the leading causes of death and disability and the main cause of death among the under-45s. Most patients with moderate to severe TBI are admitted to intensive care units (ICUs).

The 'PROmoting patient SAFEty and quality improvement in critical care' ICU network was recently established in 6 European countries through European Union funding (PHEA 2007331), and has continued to collect high-quality data beyond the grant duration. In 2012, 242 ICUs had joined 'PROmoting patient SAFEty and quality improvement in critical care', recruiting a total of 85,965 patients. Of these ICUs, 180 admitted at least one TBI patient, totaling more than 3,300 cases. Hence, the network is expected to enroll 7-9,000 moderate-to-severe TBI patients in 4 years, in about 125 participating ICUs. The 'PROmoting patient SAFEty and quality improvement in critical care' consortium has already focused attention on TBI and has just started collecting additional information on this condition in order to develop a prognostic model to identify centers of excellence in TBI management. Aims of the CREACTIVE project are to consolidate the existing network in order to better describe the epidemiology of moderate-to-severe TBI in 7 countries (Cyprus, Greece, Hungary, Israel, Italy, Poland, Slovenia); establish centralized repositories of biological samples (blood and derived fluids, CSF) and clinical imaging data, to be exploit for prognostic purposes; build a prognostic model based on clinical and biological data to predict short- and long-term outcome; identify most effective clinical interventions for optimally treating TBI patients; recognize the determinants of optimal vs. suboptimal performance.

All patients admitted to the participating ICUs with a diagnosis of traumatic brain injury, regardless of their severity, will be recruited. Centralized repositories of imaging data and biological samples for the analysis of phenotypic and genotypic biomarkers will be established for approx. 2,000 adult TBI patients.

Follow-up will be performed six months after the trauma event, and will be two-tiered. The first level will be administered over the phone and constituted of the extended version of the Glasgow Outcome Scale (GOSe) and a health-related quality of care questionnaire. The second level will encompass a patient's full examination that, for children, will include a dedicated sleep disturbances study. The second level follow-up will be performed in a selected subgroup of ICUs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Campania
      • Napoli, Campania, Italy, 80100
        • Ospedale Santa Maria di Loreto
    • Emilia Romagan
      • Bologna, Emilia Romagan, Italy, 40131
        • Ospedale Maggiore
    • Emilia Romagna
      • Cesena, Emilia Romagna, Italy, 47023
        • AUSL della Romagna, Ospedale Bufalini
    • Lazio
      • Roma, Lazio, Italy, 00152
        • Ospedale San Camillo Forlanini
    • Lombardia
      • Cremona, Lombardia, Italy, 26100
        • Presidio Ospedliero di Cremon
      • Milano, Lombardia, Italy, 20162
        • Niguarda Cà Granda
    • Lombradia
      • Lecco, Lombradia, Italy, 23900
        • Ospedale A. Manzoni
    • Marche
      • Pesaro, Marche, Italy, 61100
        • Ospedale San Salvatore
    • Piemonte
      • Alessandria, Piemonte, Italy, 15100
        • SS. Antonio e Biagio e C. Arrigo
      • Pinerolo, Piemonte, Italy, 10064
        • Ospedale Edoardo Agnelli
      • Torino, Piemonte, Italy, 10126
        • CTO Maria Adelaide
    • Puglia
      • Foggia, Puglia, Italy, 71100
        • A.O. Universitaria Policlinico "Riuniti"
    • Sardegna
      • Olbia, Sardegna, Italy, 07026
        • Ospedale Giovanni Paolo II
    • Sicilia
      • Palermo, Sicilia, Italy, 90100
        • AO Villa Sofia - Cervello
    • Toscana
      • Borgo San Lorenzo, Toscana, Italy, 50032
        • Ospedale del Mugello
      • Firenze, Toscana, Italy, 50134
        • AO Universitaria Careggi
      • Pisa, Toscana, Italy, 56100
        • Ospedale di S. Chiara
      • Pisa, Toscana, Italy, 56100
        • Ospedale di Santa Chiara
    • Umbria
      • Perugia, Umbria, Italy, 06100
        • Ospedale Santa Maria Della Misericordia
    • Valle d'Aosta
      • Aosta, Valle d'Aosta, Italy, 11100
        • Ospedale Regionale della Valle d'Aosta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

TBI patients admitted to ICU for specific care

Description

Inclusion Criteria:

All patients admitted to the participating ICUs with a diagnosis of traumatic brain injury, regardless of their severity,will be recruited.

Exclusion Criteria:

Absence of Informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
TBI admitted to ICU
Intensive Care treatment
Other: Intensive Care treatment
intensive care treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Glasgow Outcome Scale Extendend (GOSe)
Time Frame: 6 months
6 months
Quality of life in Brain Injury Overall Scale (QOLIBRI-OS)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mortality
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of Warsaw
European Commission
Semmelweis University
Ben-Gurion University of the Negev
University of Nicosia
General Hospital Novo Mesto
Univerzitetni Klinikni Center Ljubljana
University of Crete Medical School - University Hospital of Heraklion
Orobix Srl

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guido Bertolini, MD, Istituto Di Ricerche Farmacologiche Mario Negri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 602714

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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