NCT03069755

Brief Summary

This study aims to estimate the perioperative mortality rate in adult trauma patients undergoing acute surgery as well as the association between type of acute surgery and perioperative mortality in 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 2017

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, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

February 27, 2017

Last Update Submit

February 18, 2020

Conditions

Trauma

Keywords

IndiaPerioperative mortalityTraumaSurgery

Outcome Measures

Primary Outcomes (2)

  • Patient death

    Within 48 hours of arrival

  • Patient death

    Within 30 days of arrival

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

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

Adult trauma patients undergoing acute surgery

You may qualify if:

  • Presenting alive to participating hospitals with history of trauma
  • ≥ 15 years
  • That the patient underwent surgical intervention within 24 hours of arrival

You may not qualify if:

  • \- Isolated limb 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
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 3, 2017

Study Start

January 1, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share