NCT03698214

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
Last Updated

October 5, 2018

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

October 2, 2018

Last Update Submit

October 4, 2018

Conditions

Keywords

systolic blood pressurereversed shock indextraumatic brain injurymortality

Outcome Measures

Primary Outcomes (1)

  • in-hospital mortality

    To measure the outcome of patients.

    up to 5 months

Study Arms (1)

isolated traumatic brain injury

Adult patients having isolated traumatic brain injury with a head abbreviated injury scale (AIS) ≥ 3 and without severe injury to other regions (other AIS ≤ 1) were included. The patients were grouped and analyzed according to reversed shock index \< 1 or reversed shock index ≥ 1.

Other: reversed shock index < 1Other: reversed shock index ≥ 1

Interventions

Among patients with isolated TBI, those with an RSI ≥ 1 had lower mortality

isolated traumatic brain injury

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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. We excluded patients younger than 18 or older than 65 years of age. Patients were grouped and analyzed according to RSI (\< 1 or ≥ 1).

You may qualify if:

  • 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

You may not qualify if:

  • Patients with incomplete registered data were also excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 5, 2018

Study Start

March 23, 2016

Primary Completion

January 23, 2017

Study Completion

February 22, 2017

Last Updated

October 5, 2018

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data available.