RegistriesNCT03618446
Predictors Of Mortality After Pelvic Fractures: A Retrospective Cohort Study From A Level-1 Trauma Center In Upper Egypt
An observational study of Registries and Pelvic Bone Injury, run by Assiut University.
Trial summary
A retrospective cohort study was carried out for all pelvic fracture patients admitted to Assiut University Trauma Unit (AUTU), a level-1 trauma center. (AUTU) is located in Upper Egypt and provides healthcare to over 30,000 patients per year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Registries, Pelvic Bone Injury, Morality
- What is being tested?
- The presence of a pelvic fracture
- How many people
- 1,188 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to Sep 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: 1188 patients were considered eligible for analysis. These were further divided into an adult cohort whose age is above 16 years (951 patients) and a pediatric cohort (237 patients).
Who may be able to join
- first-time admissions and patients whose treatment was completed at our hospital
- all pelvic fracture patients admitted to our Trauma Unit.
Who cannot join
- penetrating injuries
- isolated acetabular fractures
- Patients who were discharged on their own will against the medical advice or whose treatment was continued at another hospital
- re-admitted patients
- Firearm injuries
About this study
Official title: Predictors Of Mortality After Pelvic Fractures: A Retrospective Cohort Study From A Level-1 Trauma Center In Upper Egypt.
A retrospective cohort study was carried out for all pelvic fracture patients admitted to Assiut University Trauma Unit (AUTU), a level-1 trauma center. (AUTU) is located in Upper Egypt and provides healthcare to over 30,000 patients per year.
Read the detailed description
In 2010, a Pelvic Injury Registry was developed to document treatment and outcomes in a standardized manner. All patients admitted to AUTU sign an informed consent to permit using their data for research purposes. Patients' data are prospectively collected and stored in a local database specifically designed for this purpose.
Data collected included age, gender, mechanism of injury, fracture classification, associated injuries, and admission to ICU, the length of hospital stay and presence of abdominopelvic collection as diagnosed by Focused Assessment with Sonography for Trauma (FAST) at admission. The primary outcome measure was in-hospital mortality. Predictors of in-hospital mortality were identified by comparing characters of survivors and non-survivors. Secondary objectives were to analyse the differences between adults and children and to analyse the causes and timing of death.
- Conditions
- Registries, Pelvic Bone Injury, Morality
- Being tested
- The presence of a pelvic fracture
- Keywords
- Pelvic fractures, mortality, predictors, trauma registry
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The presence of a pelvic fractureOther
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Patients whose pelvic fracture and survived till time of discharge from the hospital. Receives: Other: The presence of a pelvic fracture | |
| Non-Survivors | Patients whose pelvic fracture and died while in hospital. Receives: Other: The presence of a pelvic fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
Death occurring while the patient is admitted in the hospital.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Jan 2010
- Primary completion31 Dec 2013
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RegistriesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 1,188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- AO Clinical Investigation and Publishing Documentation
- Responsible party
- Principal investigator, Osama Farouk, Assiut University
- Investigators
- Osama Farouk, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618446
- Sponsor's protocol ID
- 17100526
- Status last verified
- Feb 2022
- First submitted
- 5 Jul 2018
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors Of Mortality After Pelvic Fractures: A Retrospective Cohort Study From A Level-1 Trauma Center In Upper Egypt.
- ClinicalTrials.gov ID
- NCT03618446
- Acronym / sponsor ID
- 17100526
- Conditions
- Registries, Pelvic Bone Injury, Morality
- Keywords
- Pelvic fractures, mortality, predictors, trauma registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,188 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- AO Clinical Investigation and Publishing Documentation
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Aug 2018 (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.
A retrospective cohort study was carried out for all pelvic fracture patients admitted to Assiut University Trauma Unit (AUTU), a level-1 trauma center. (AUTU) is located in Upper Egypt and provides healthcare to over 30,000 patients per year.
Detailed description
In 2010, a Pelvic Injury Registry was developed to document treatment and outcomes in a standardized manner. All patients admitted to AUTU sign an informed consent to permit using their data for research purposes. Patients' data are prospectively collected and stored in a local database specifically designed for this purpose.
Data collected included age, gender, mechanism of injury, fracture classification, associated injuries, and admission to ICU, the length of hospital stay and presence of abdominopelvic collection as diagnosed by Focused Assessment with Sonography for Trauma (FAST) at admission. The primary outcome measure was in-hospital mortality. Predictors of in-hospital mortality were identified by comparing characters of survivors and non-survivors. Secondary objectives were to analyse the differences between adults and children and to analyse the causes and timing of death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Other: The presence of a pelvic fracturePatients whose pelvic fracture and survived till time of discharge from the hospital. |
| Non-Survivors | – | Other: The presence of a pelvic fracturePatients whose pelvic fracture and died while in hospital. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 1188 patients were considered eligible for analysis. These were further divided into an adult cohort whose age is above 16 years (951 patients) and a pediatric cohort (237 patients).
Key inclusion criteria (2 listed)
- first-time admissions and patients whose treatment was completed at our hospital
- all pelvic fracture patients admitted to our Trauma Unit.
Key exclusion criteria (5 listed)
- penetrating injuries
- isolated acetabular fractures
- Patients who were discharged on their own will against the medical advice or whose treatment was continued at another hospital
- re-admitted patients
- Firearm injuries
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 |
|---|---|---|
| The presence of a pelvic fracture | Other | Non-Survivors, Survivors |
Primary outcome
in-hospital mortality
Time frame: One month
Death occurring while the patient is admitted in the hospital.
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 16 Feb 2022.
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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.
Osama Farouk principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Registries and Pelvic Bone Injury, run by Assiut University.
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 5 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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
in-hospital mortality (time frame: One month). 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 16 Feb 2022.