NCT02716649

Brief Summary

In this project, we derive survival risk ratios (SRR) based on International Classification of Disease version 10 (ICD-10) injury codes to validate the ICD Injury Severity Score (ICISS) in data from four public university hospitals in India.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16,047

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

March 10, 2016

Last Update Submit

February 26, 2017

Conditions

Keywords

TraumaICISSIndiaICD-10

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Within 30 days of patient arrival to participating centre

Secondary Outcomes (1)

  • Mortality

    Within 24 hours of patient arrival to participating centre

Study Arms (1)

All participants

No intervention

Other: No intervention

Interventions

All participants

Eligibility Criteria

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

Trauma patients presenting to four public university hospitals in urban India

You may qualify if:

  • Patients with a history of trauma that arrived alive to the study hospitals and were admitted or died between arrival and admission were included.

You may not qualify if:

  • Patients with isolated fractures without vascular injury were excluded because they generally go into the orthopaedic pathway instead of the trauma pathway.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 23, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 28, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Yes, by upload to public data repository such as figshare or equivalent