CINTER-TBI India Core Study
The CINTER-TBI India study was conducted in 2 major trauma centers in New Delhi, India A total of 1046 patients were in the Core dataset.
The E-CRF used was the same as for CENTER-TBI and OzENTER, all three studies were longitudinal cohort studies with harmonized data points and outcome assessments, and the same inclusion criteria were valid, but for logistic reasons, not all variables from CENTER-TBI have been captured in CINTER-TBI India.
Therefor this dataset is more limited compared to CENTER-TBI. This is a non-exhaustive list of data that was not or less captured: only CT scans (no MRI) in acute phase; no lab sampling performed; no registration of ICD codes; no brain monitoring; only 3 and 6 month outcome; only questionnaires performed as outcome assessments (at 3/6 month).
For the 3 and 6 month GOSE scoring, the Indian investigators did not perform a structured interview (as was done in CENTER-TBI), since this was too time consuming for many patients. The investigator asked some general questions about quality of life and how the patient felt and then completed the GOSE questionnaire in the e-CRF based on their clinical judgement. Hence, the “Outcomes.GOSEScore” variable is a guided interview, in line with the original GOS approach, in which the clinician has a description of different GOS categories and, based on the information available, makes a judgement about the overall rating.
Design
- Study design
- Other : Study design and e-CRF for data collection were copied from the CENTER-TBI study to provide harmonized data points and outcome assessments and allow for comparison between both studies.
Recruitment
- Sources of Recruitment
-
Number of participants
- Number of participants
- 1,046
- Number of participants with biosamples
Access
Available on request
| Data | |
| Biosamples | |
| CT/MRI scans and HR ICU meta data |
Timeline
TBI patients CINTER-TBI
Patients that presented to the hospital with Traumatic Brain Injury within 24 hours after injury.
Selection Criteria
- Countries
-
- India
- Other criteria
-
Inclusion Criteria:
- Clinical diagnosis of TBI
- Clinical indication for CT scan
Exclusion Criteria:
- Severe pre-existing neurological disorder that would confound outcome assessments
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Patients with TBI
Number of participants
- Number of participants
- 1,046
- Number of participants with biosamples
Data Collection Event
- Start Date
-
2016-07
- End Date
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2017-12
- Data sources
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- Acute care data
- Imaging
- Questionnaires