NCT07816016

Brief Summary

This prospective observational study aims to develop and internally validate a new clinical score, the FOUR-Rapid Emergency Medicine Score (fREMS), for predicting in-hospital mortality in patients with traumatic brain injury (TBI). The study will assess whether combining the Full Outline of UnResponsiveness (FOUR) score with physiological and clinical parameters from the Rapid Emergency Medicine Score (REMS) can improve early mortality prediction. The main question it aims to answer is: Can the fREMS score accurately predict the risk of in-hospital mortality in patients with traumatic brain injury? Data on demographic characteristics, vital signs, neurological assessment, and other relevant clinical variables will be collected from eligible patients with TBI and used to develop and validate the fREMS score.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress9%
Sep 2026Oct 2027

Study Start

First participant enrolled

September 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 7, 2026

Last Update Submit

September 11, 2026

Conditions

TBITBI Traumatic Brain Injury

Keywords

TBIfREMSTrauma score

Outcome Measures

Primary Outcomes (1)

  • In hospital mortality

    Mortality (death) during hospitalization

    In-Hospital Phase (average of 15 days through discharge)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adult patients (≥16 years) with acute traumatic brain injury (TBI).

You may qualify if:

  • Patients with sufficient clinical data to calculate the fREMS score, including the FOUR Score and other required physiological variables.
  • Patients with a documented mortality outcome .

You may not qualify if:

  • Patients transferred from another hospital after initial resuscitation.
  • Patients who died before the required initial clinical assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College Of Medicine - Nahrain University

Baghdad, Baghdad Governorate, 10011, Iraq

Location

Related Publications (5)

  • Xiao Y, Jin H, Mei H, Liu X, Chen T, Liu Z, Jiang D, Zhou J, Yan J, Liang H. [The predictive value of combination of anatomic scoring system and physiological scoring system in prediction of death in patients with severe trauma: a multicenter analysis of 614 cases]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2015 Apr;27(4):291-4. doi: 10.3760/cma.j.issn.2095-4352.2015.04.013. Chinese.

    PMID: 25891460BACKGROUND

  • Beuran M, Negoi I, Paun S, Runcanu A, Gaspar B, Vartic M. [Trauma scores: a review of the literature]. Chirurgia (Bucur). 2012 May-Jun;107(3):291-7. Romanian.

    PMID: 22844826BACKGROUND

  • Omar A, Winkelmann M, Liodakis E, Clausen JD, Graulich T, Omar M, Krettek C, Macke C. Applicability of Anatomic and Physiologic Scoring Systems for the Prediction of Outcome in Polytraumatized Patients with Blunt Aortic Injuries. Diagnostics (Basel). 2021 Nov 21;11(11):2156. doi: 10.3390/diagnostics11112156.

    PMID: 34829503BACKGROUND

  • Rapsang AG, Shyam DC. Scoring systems of severity in patients with multiple trauma. Cir Esp. 2015 Apr;93(4):213-21. doi: 10.1016/j.ciresp.2013.12.021. Epub 2014 Jul 8. English, Spanish.

    PMID: 25015031BACKGROUND

  • Alberdi F, Garcia I, Atutxa L, Zabarte M; Trauma and Neurointensive Care Work Group of the SEMICYUC. Epidemiology of severe trauma. Med Intensiva. 2014 Dec;38(9):580-8. doi: 10.1016/j.medin.2014.06.012. Epub 2014 Sep 18. English, Spanish.

    PMID: 25241267BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Abdulillah R. Khamees, MBBCH

CONTACT

07838571013abdulilah.r.khamis@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 11, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)