- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04999397
Penetrating Cardiac Injuries: Outcome of Treatment From a Level 1 Trauma Centre in South
August 18, 2021 updated by: Maeyane Stephens Moeng, University of Witwatersrand, South Africa
Retrospective observational study design auditing the outcomes of cardiac injuries in a single centre
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
167
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gautheng
-
Johannesburg, Gautheng, South Africa, 2193
- Charlotte Maxeke Johanneburg Academic Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients who sustained a penetrating injury to the heart presenting at a single trauma unit
Description
Inclusion Criteria: All Priority one penetrating cardiac injuries seen at CMJAH in patients who were 18 years and older -
Exclusion Criteria: Dead on arrival
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
List injury patterns
Time Frame: study period (Jan 2018-Dec 2019)
|
chamber involved
|
study period (Jan 2018-Dec 2019)
|
|
List of Mechanisms seen
Time Frame: study period (Jan 2016-Dec 2019)
|
describe the type of mechanism involved in injury
|
study period (Jan 2016-Dec 2019)
|
|
outcomes
Time Frame: study period (Jan 2016-Dec 2019)
|
overall inhospitable mortality and outcomes
|
study period (Jan 2016-Dec 2019)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maeyane Moeng, University of Witwatersrand, South Africa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
August 9, 2021
First Submitted That Met QC Criteria
August 9, 2021
First Posted (Actual)
August 10, 2021
Study Record Updates
Last Update Posted (Actual)
August 25, 2021
Last Update Submitted That Met QC Criteria
August 18, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M180463
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.