TraumaNCT04881279
Maintaining Optimal Trauma Outcomes: Resilience in the Midst of a Ransomware Attack
An observational study of Trauma and Electronic Health Record, run by State University of New York at Buffalo at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, Electronic Health Record
- What is being tested?
- Event
- How many people
- 846 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Trauma patients being served by the level I trauma center catchment area in Western New York, Southern Ontario (Canada), and Northern Pennsylvania
Who may be able to join
- 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
Who cannot join
- -Patients who came through the emergency department that were not categorized as trauma patients
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
On April 9, 2017, Erie County Medical Center, Western New York's sole level I trauma center was under cyberattack. The perpetrators utilized ransomware that gained access to the hospital's web server and encrypted hospital data, forcing a system-wide downtime for nearly 2 months. Electronic medical records, imaging, and interdepartmental communication were severely affected, forcing the hospital to temporarily return to pre-EMR era operations. We examined the impact of this cyber disaster on the outcomes of trauma care.
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, and 2018. Baseline characteristics of study cohort for each period will be examined using the chi-square test for categorical variables and the Student's t-test for continuous variables that are normally distributed.
This was an exempt study in our institution.
- Conditions
- Trauma, Electronic Health Record
- Being tested
- Event
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EventOther
Ransomware attack
| Study group | Role | What they receive |
|---|---|---|
| Control | Trauma admissions in April-June 2016. | |
| Ransomware Group | Trauma admissions in April-June 2017. Receives: Other: Event |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Disposition at discharge defined as either discharged home, died, or sent to a rehabilitation facility, all expressed as the proportion of the cohort group with the above-mentioned findings reported in percentages
All AHRQ patient safety indicators: DVT/PE, CLABSI, CAUTI, and organ/space surgical infection are indicated as the proportion of the cohort group with the above-mentioned findings reported in percentages
Measured: April to June 2016 and 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 Apr 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 846 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidun Alan Guo, MD, PhD, State University of New York at Buffalo
- Investigators
- W. Alan Guo, MD, PhD, Principal investigator, State University of Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881279
- Sponsor's protocol ID
- STUDY00002779
- Status last verified
- May 2021
- First submitted
- 21 Apr 2021
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Optimal Trauma Outcomes: Resilience in the Midst of a Ransomware Attack
- ClinicalTrials.gov ID
- NCT04881279
- Acronym / sponsor ID
- STUDY00002779
- Conditions
- Trauma, Electronic Health Record
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 846 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
On April 9, 2017, Erie County Medical Center, Western New York's sole level I trauma center was under cyberattack. The perpetrators utilized ransomware that gained access to the hospital's web server and encrypted hospital data, forcing a system-wide downtime for nearly 2 months. Electronic medical records, imaging, and interdepartmental communication were severely affected, forcing the hospital to temporarily return to pre-EMR era operations. We examined the impact of this cyber disaster on the outcomes of trauma care.
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, and 2018. Baseline characteristics of study cohort for each period will be examined using the chi-square test for categorical variables and the Student's t-test for continuous variables that are normally distributed.
This was an exempt study in our institution.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Trauma admissions in April-June 2016. |
| Ransomware Group | – | Other: EventTrauma admissions in April-June 2017. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Trauma patients being served by the level I trauma center catchment area in Western New York, Southern Ontario (Canada), and Northern Pennsylvania
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -Patients who came through the emergency department that were not categorized as trauma patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EventRansomware attack | Other | Ransomware Group |
Primary outcome
Hospital and ICU length of stay (LOS), and in-hospital mortality
Time frame: April to June 2016 and 2017
Hospital and ICU length of stay (LOS) in days And in-hospital mortality between cohorts expressed as percentage of cohort
1 secondary outcome
Disposition at discharge and AHRQ patient safety indicators: DVT/PE, CLABSI, CAUTI, and organ/space surgical infection.
Time frame: April to June 2016 and 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Alan Guo, MD, PhD principal investigator
State University of Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Electronic Health Record, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital and ICU length of stay (LOS), and in-hospital mortality (time frame: April to June 2016 and 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.