Morbidity and Mortality in Solo Adult Traumatic Brain Inj... | NCT05075239

Studies
Morbidity and Mortality in Solo Adult Traumatic Brain Injury Patients in Minia University Hospital

NCT05075239

Sponsor

Minia University

Status

Completed

Last Update Posted

Feb 4, 2022Actual

Enrollment

62Actual

Phase

Not provided

Conditions

Statistical Analysis of Traumatic Brain Injury Victims

Interventions

Not provided

Countries

Egypt

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

Feb 2022

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

Sep 15, 2021Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Jan 15, 2022Actual

First Submitted Date

Sep 29, 2021

First Submission Date that Met QC Criteria

Sep 29, 2021

First Posted Date

Oct 12, 2021Actual

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

Feb 3, 2022

Last Update Posted Date

Feb 4, 2022Actual

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

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

62Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality and morbidity	number of deaths from neurotrauma	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
prediction	to examine the predictors of outcome including age , gender , admission systolic blood pressure < 90 mmHg , GCS score ,APACHE II score ,lateralization of pupil , brain CT findings ,serum sodium &potassium ,mechanical ventilation and length of stay in ICU	one week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Solo non penetrating neurotrauma victims

Exclusion Criteria:

1- Penetrating head trauma. 2- Polytrauma patients. 3- Coexist of Psychiatric disorders or history of neuronal disorders. 4- Refusal of patient relatives to participate in the assignment. 5- Pregnant females with TBI. 6- Patients who died during 24 hours from admission to ICU . 7- Patients more than 65 years of age .

8- combined abdominal or orthopedic trauma.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

both sexes with individual neurotrauma

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Maher Maher		Minya	Egypt	6115	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided