NCT04881279

Brief Summary

Retrospective review of de-identified hospital emergency room and trauma registry data and operating room case logs from April 9th through June 9th, 2016, 2017 examining outcomes as affected by a ransomware attack in a level I trauma center

Trial Health

87
On Track

Trial Health Score

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

Enrollment
846

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

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

Study Start

First participant enrolled

April 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
Last Updated

December 27, 2023

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

April 21, 2021

Last Update Submit

December 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital and ICU length of stay (LOS), and in-hospital mortality

    Hospital and ICU length of stay (LOS) in days And in-hospital mortality between cohorts expressed as percentage of cohort

    April to June 2016 and 2017

Secondary Outcomes (1)

  • Disposition at discharge and AHRQ patient safety indicators: DVT/PE, CLABSI, CAUTI, and organ/space surgical infection.

    April to June 2016 and 2017

Study Arms (2)

Control

Trauma admissions in April-June 2016.

Ransomware Group

Trauma admissions in April-June 2017.

Other: Event

Interventions

EventOTHER

Ransomware attack

Ransomware Group

Eligibility Criteria

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

Trauma patients being served by the level I trauma center catchment area in Western New York, Southern Ontario (Canada), and Northern Pennsylvania

You may qualify if:

  • All trauma patient admissions that were seen through the ECMC Trauma Center from April to June 2016 and April to June 2017
  • Adult patients \>13 years old

You may not qualify if:

  • Patients who came through the emergency department that were not categorized as trauma patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • W. Alan Guo, MD, PhD

    State University of Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 21, 2021

First Posted

May 11, 2021

Study Start

April 1, 2017

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

December 27, 2023

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations