Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02004080 |
| Other study ID # |
602714 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2013 |
| Est. completion date |
March 2019 |
Study information
| Verified date |
March 2022 |
| Source |
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI)
care in the ICU setting
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.
