NCT07582263

Brief Summary

This study aimed to test the hypothesis that a practical, bedside-applicable tool could be developed to help identify patients at high risk of mortality following motorcycle accidents more quickly and facilitate treatment by enabling faster clinical decision-making.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 6, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Completed
Last Updated

June 16, 2026

Status Verified

May 1, 2026

Enrollment Period

28 days

First QC Date

May 6, 2026

Last Update Submit

June 13, 2026

Conditions

Keywords

motorsyclethoraxtraumaseverity scoremortality

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    30 days after ICU admission

Secondary Outcomes (4)

  • Develop and validate the model

    30 days after ICU admission

  • Assess the model's discriminatory performance, calibration and classification accuracy

    30 days after ICU admission

  • Classify patients into clinically meaningful risk categories

    30 days after ICU admission

  • Assess the independent contribution of helmet use and chest injury patterns to mortality prediction

    30 days after ICU admission

Study Arms (2)

Training set

Other: Training set

Test set

Other: Test set

Interventions

Training set for model development

Training set

Independent test set for validation

Test set

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study planned to include patients aged 18 years and over who had been involved in a motorcycle accident (as a rider or passenger) and had a chest injury that had been radiologically or clinically confirmed, as well as patients whose medical records had been fully documented during the chart review.

You may qualify if:

  • patients aged 18 years or over
  • motorcycle accident (a rider or a passenger)
  • radiologically or clinically confirmed chest injury
  • fully documented in the medical records.

You may not qualify if:

  • penetrating chest trauma
  • patients under the age of 18
  • isolated non-chest trauma
  • incomplete documentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (2)

  • Lavoie A, Moore L, LeSage N, Liberman M, Sampalis JS. The New Injury Severity Score: a more accurate predictor of in-hospital mortality than the Injury Severity Score. J Trauma. 2004 Jun;56(6):1312-20. doi: 10.1097/01.ta.0000075342.36072.ef.

    PMID: 15211142BACKGROUND
  • Schluter PJ. Trauma and Injury Severity Score (TRISS): is it time for variable re-categorisations and re-characterisations? Injury. 2011 Jan;42(1):83-9. doi: 10.1016/j.injury.2010.08.036.

    PMID: 20851396BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Nilay Cavusoglu Yalcın

    University of Health Sciences, Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 12, 2026

Study Start

May 6, 2026

Primary Completion

June 3, 2026

Study Completion

June 10, 2026

Last Updated

June 16, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations