Brain Injuries, TraumaticCREACTIVENCT02004080
CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
An observational study of Brain Injuries, Traumatic, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva at 20 sites in Italy.
Trial summary
CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI) care in the ICU setting Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Intensive Care treatment
- How many people
- 8,000 participants
- Where
- 20 sitesItaly
- Study dates
- Oct 2013to Mar 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: TBI patients admitted to ICU for specific care
Who may be able to join
- All patients admitted to the participating ICUs with a diagnosis of traumatic brain injury, regardless of their severity,will be recruited.
Who cannot join
- Absence of Informed consent
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
SS. Antonio e Biagio e C. Arrigo
Alessandria, Piedmont, 15100
Ospedale Regionale della Valle d'Aosta
Aosta, Aosta Valley, 11100
Ospedale Maggiore
Bologna, Emilia Romagan, 40131
Ospedale del Mugello
Borgo San Lorenzo, Tuscany, 50032
AUSL della Romagna, Ospedale Bufalini
Cesena, Emilia-Romagna, 47023
Presidio Ospedliero di Cremon
Cremona, Lombardy, 26100
AO Universitaria Careggi
Florence, Tuscany, 50134
A.O. Universitaria Policlinico "Riuniti"
Foggia, Apulia, 71100
Ospedale A. Manzoni
Lecco, Lombradia, 23900
Niguarda Cà Granda
Milan, Lombardy, 20162
Ospedale Santa Maria di Loreto
Naples, Campania, 80100
Ospedale Giovanni Paolo II
Olbia, Sardinia, 07026
AO Villa Sofia - Cervello
Palermo, Sicily, 90100
Ospedale Santa Maria della Misericordia
Perugia, Umbria, 06100
Ospedale San Salvatore
Pesaro, The Marches, 61100
Ospedale Edoardo Agnelli
Pinerolo, Piedmont, 10064
Ospedale di S. Chiara
Pisa, Tuscany, 56100
Ospedale di Santa Chiara
Pisa, Tuscany, 56100
Ospedale San Camillo Forlanini
Rome, Lazio, 00152
CTO Maria Adelaide
Turin, Piedmont, 10126
About this study
CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI) care in the ICU setting
Read the 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.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Intensive Care treatment
- Keywords
- TBI, ICU, Comparative Effectiveness Research
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Care treatmentOther
intensive care treatment
| Study group | Role | What they receive |
|---|---|---|
| TBI admitted to ICU | Intensive Care treatment Receives: Other: Intensive Care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale Extendend (GOSe)
Measured: 6 months
Quality of life in Brain Injury Overall Scale (QOLIBRI-OS)
Measured: 6 months
Secondary outcomes (1)
Mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, Semmelweis University, Medical University of Warsaw, General Hospital of Novo mesto, Univerzitetni Klinikni Center Ljubljana, University of Nicosia, Ben-Gurion University of the Negev, University General Hospital of Heraklion, Orobix Srl
- Responsible party
- Sponsor
- Investigators
- Guido Bertolini, MD, Principal investigator, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004080
- Sponsor's protocol ID
- 602714
- Acronym
- CREACTIVE
- Status last verified
- Mar 2022
- First submitted
- 3 Dec 2013
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
- ClinicalTrials.gov ID
- NCT02004080
- Acronym / sponsor ID
- CREACTIVE / 602714
- Conditions
- Brain Injuries, Traumatic
- Keywords
- TBI, ICU, Comparative Effectiveness Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia IntensivaUniversity, hospital or other
- Collaborators
- European Commission, Semmelweis University, Medical University of Warsaw, General Hospital of Novo mesto, Univerzitetni Klinikni Center Ljubljana, University of Nicosia, Ben-Gurion University of the Negev, University General Hospital of Heraklion, Orobix Srl
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 6 Dec 2013 (estimated)
- 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.
CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI) care in the ICU setting
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBI admitted to ICU | – | Other: Intensive Care treatmentIntensive Care treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- TBI patients admitted to ICU for specific care
Key inclusion criteria (1 listed)
- All patients admitted to the participating ICUs with a diagnosis of traumatic brain injury, regardless of their severity,will be recruited.
Key exclusion criteria (1 listed)
- Absence of Informed consent
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 |
|---|---|---|
| Intensive Care treatmentintensive care treatment | Other | TBI admitted to ICU |
Primary outcome
Glasgow Outcome Scale Extendend (GOSe)
Time frame: 6 months
Quality of life in Brain Injury Overall Scale (QOLIBRI-OS)
Time frame: 6 months
1 secondary outcome
Mortality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Related infoLink provided by the sponsor.
- CREACTIVE websiteLink provided by the sponsor.
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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.
Guido Bertolini, MD principal investigator
Istituto Di Ricerche Farmacologiche Mario Negri
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva at 20 sites in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale Extendend (GOSe) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.