Penetrating Cardiac Injuries: Outcome of Treatment From a... | NCT04999397

Studies
Penetrating Cardiac Injuries: Outcome of Treatment From a Level 1 Trauma Centre in South

NCT04999397

Sponsor

University of Witwatersrand, South Africa

Status

Completed

Last Update Posted

Aug 25, 2021Actual

Enrollment

167Actual

Phase

Not provided

Conditions

Penetrating Cardiac Trauma

Interventions

standards clinical management

Countries

South Africa

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

Aug 2021

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

Jan 1, 2016Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Aug 9, 2021

First Submission Date that Met QC Criteria

Aug 9, 2021

First Posted Date

Aug 10, 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

Aug 18, 2021

Last Update Posted Date

Aug 25, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maeyane Stephens Moeng, Director of Trauma, University of Witwatersrand, South AfricaPrincipal Investigator

Lead Sponsor

University of Witwatersrand, South AfricaOTHER

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

Retrospective observational study design auditing the outcomes of cardiac injuries in a single centre

Detailed Description

retrospective study over a two-year period. The demographics, injury sustained, clinical physiological parameters, mechanism of injury, injury site and patterns, outcomes and in-hospital mortality description of patients who were admitted at a single centre for further management of their cardiac injuries. Investigations performed, and procedures that were undertaken were also documented. Descriptive statistical analysis was performed. P-value of <0,05 was considered clinically significant.

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

167Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standards clinical management	Other	outcomes seen in cardiac injuries post clincal care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
List injury patterns	chamber involved	study period (Jan 2018-Dec 2019)
List of Mechanisms seen	describe the type of mechanism involved in injury	study period (Jan 2016-Dec 2019)
outcomes	overall inhospitable mortality and outcomes	study period (Jan 2016-Dec 2019)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: All Priority one penetrating cardiac injuries seen at CMJAH in patients who were 18 years and older -

Exclusion Criteria: Dead on arrival

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients who sustained a penetrating injury to the heart presenting at a single trauma unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maeyane Moeng	University of Witwatersrand, South Africa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charlotte Maxeke Johanneburg Academic Hospital		Johannesburg	Gautheng	2193	South Africa

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