NCT03450525

Brief Summary

The study aims to assess whether time between injury and first Glasgow Coma Scale measurement will affect its predictive value.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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 15, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

6.5 years

First QC Date

February 23, 2018

Last Update Submit

September 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Death within 30 days of injury

    Patients discharged alive before 30 days were considered alive at 30 days after injury.

    30 days

Interventions

No intervention

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult trauma patients with TBI admitted to four public university hospitals in urban India

You may qualify if:

  • History of trauma (road traffic injury, railway injury, fall, assault or burns)
  • ≥ 15 years old
  • Patients presenting with TBI. TBI being defined as having any of the ICD codes S02.0-1, S02.8-9, S04.0-9, S06.0-9, S07.0-1, S07.8-9, S09.8-9.0.

You may not qualify if:

  • Dead on arrival
  • Isolated limb injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College

Mumbai, Maharashtra, 400012, India

Location

Lokmanya Tilak Municipal General Hospital

Mumbai, Maharashtra, 400022, India

Location

AIIMS Jai Prakash Narayan Apex Trauma Center

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

Kolkata, West Bengal, 700020, India

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

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

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

January 15, 2018

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations