NCT02724007

Brief Summary

The aim of this study is to validate international versions of the International Classification of Disease Injury Severity Score (ICISS) in adult trauma patients admitted to four public university hospitals in urban 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
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 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 27, 2016

Last Update Submit

February 26, 2017

Conditions

Wounds and Injuries

Keywords

TraumaIndiaICISS

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

Eligibility Criteria

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

The study population is patients admitted with a history of trauma in any of the study centers, or patients who died between arrival and admission. Patients who were dead on arrival to the hospital were excluded. Patients with isolated limb fractures without vascular injuries were excluded, due to the administration of these patients in the study centers.

You may qualify if:

  • History of trauma or death between arrival and admission

You may not qualify if:

  • Isolated limb fractures without vascular injury

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
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 27, 2016

First Posted

March 31, 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