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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03698214
Other study ID # CGRPG8F0011
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 23, 2016
Est. completion date February 22, 2017

Study information

Verified date March 2016
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A systolic blood pressure (SBP) lower than the heart rate (HR) could indicate a poor condition in trauma patients. In such scenarios, the reversed shock index (RSI) is <1, as calculated by the SBP divided by the HR. This study aimed to clarify whether RSI could be used to identify high-risk adult patients with isolated traumatic brain injury (TBI).


Recruitment information / eligibility

Status Completed
Enrollment 1216
Est. completion date February 22, 2017
Est. primary completion date January 23, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility Inclusion Criteria:

- Adult patients having isolated TBI with a head abbreviated injury scale (AIS) = 3 and without severe injury to other regions (other AIS = 1) were included

Exclusion Criteria:

- Patients with incomplete registered data were also excluded

Study Design


Intervention

Other:
reversed shock index < 1
Among patients with isolated TBI, those with an RSI < 1 had higher mortality
reversed shock index = 1
Among patients with isolated TBI, those with an RSI = 1 had lower mortality

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary in-hospital mortality To measure the outcome of patients. up to 5 months
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