The Impact of COVID-19 Pandemic to Trauma Patients in Eme... | NCT04479124

Studies
The Impact of COVID-19 Pandemic to Trauma Patients in Emergency Department: A Multicenter Experience of Istanbul

NCT04479124

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Jul 21, 2020Actual

Enrollment

2,000Actual

Phase

Not provided

Conditions

Trauma
Covid19

Interventions

COVID-19 PCR

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2020Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jul 14, 2020Actual

First Submitted Date

Jul 19, 2020

First Submission Date that Met QC Criteria

Jul 19, 2020

First Posted Date

Jul 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2020

Last Update Posted Date

Jul 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ramazan Guven, Proffessor, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.

Detailed Description

COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The investigators hypothesize that since the number of hospital applications expected to be decreased due to trauma during the COVID-19 period, the level of hospital trauma applications changed. Thus, the aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COVID-19 PCR	Diagnostic Test	Nasopharyngeal samples were analyzed by PCR for the detection of Novel Coronavirus 2019 DNA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
trauma admissions	within the study period, trauma patients who admitted to any of the seven study centers will be recorded.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

accepted to participate with an informed consent
trauma patients who admitted to the study centers

Exclusion Criteria:

lack of informed consent
lack of data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

The patients who admitted to any of the emergency departments of seven study centers during the pandemic will be evaluated.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Kanuni Sultan Suleyman Training and Research Hospital		Istanbul	Kucukcekmece	34303	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000087123	COVID-19 Nucleic Acid Testing

Ancestor Terms

ID	Term
D000086742	COVID-19 Testing
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided