Pelvic FractureNCT03133338
Effect of Early Pelvic Binder Use in Emergency Management of Suspected Pelvic Trauma: a Retrospective Cohort Study
An observational study of Pelvic Fracture, run by Tri-Service General Hospital (TSGH).
Trial summary
The investigators aimed to evaluate the effect of early pelvic binder use in emergency management of suspected pelvic trauma, compared with the conventional stepwise approach. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Pelvic Fracture
- What is being tested?
- pelvic binder
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2013to 31 Jul 2014
- How long will I take part?
- 3 Months
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enrolled trauma patients with initial stabilization using a pelvic binder for suspecting pelvic injury. Inclusion criteria were traumatic injury requiring a trauma team and at least one of the following: loss of consciousness or Glasgow coma score (GCS) < 13; systolic blood pressure < 90 mmHg; falling from ≥6 m; injury to multiple vital organs; and suspected pelvic injury. Various parameters, including gender, age, mechanism of injury, GCS, mortality, hospital stay, initial vital sign, revised trauma score, injury severity score, and outcome, were assessed and compared with historical controls.
Who may be able to join
- Traumatic injury requiring a trauma team and at least one of the following: loss of consciousness or Glasgow coma score (GCS) < 13; systolic blood pressure < 90 mmHg; falling from ≥6 m; injury to multiple vital organs; and suspected pelvic injury. -
Who cannot join
- Not meet the criteria and loss follow up (transfer to other hospital or data not available) -
About this study
Official title: Division of Traumatic and General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center
The investigators aimed to evaluate the effect of early pelvic binder use in emergency management of suspected pelvic trauma, compared with the conventional stepwise approach.
Read the detailed description
There is currently no universal consensus on all aspects of management of pelvic injuries.
Among patients with multiple injuries because of blunt trauma, 5%-16% sustain injuries to the pelvic ring, resulting in a mortality rate of 11%-54% primarily due to hemorrhagic shock. In theory, the reduction and stabilization of the pelvic ring can decrease bleeding from the fracture site, as reduction of pelvic volume has been shown to reduce the extent of hemorrhage from such injuries.The application of a pelvic binder has become part of the emergency care of all trauma patients with suspected pelvic fractures, in both the pre-hospital environment and emergency department (ED). The present study aimed to assess the effectiveness of the early use of pelvic binders to treat patients with a suspected high risk of pelvic bleeding from blunt force pelvic fractures.
- Conditions
- Pelvic Fracture
- Being tested
- pelvic binder
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic binderDevice
Also called Angiography for TAE
The requirement of angioembolization can be predicted by the presence of intravenous contrast extravasation (ICE) on computed tomography (CT)
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood transfusion
Pelvic fracture with hemodynamic unstable
Measured: admission
Secondary outcomes (1)
admission mortality
mortality in the same admission
Measured: mortality in the same admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Aug 2013
- Primary completion31 Jul 2014
- Study completion31 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 204 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsu Sheng-Der, Tri-Service General Hospital (TSGH)
- Investigators
- Mu-Hsien Yu, Professor, Study director, Institutional Review Board II of the Tri-Service General Hospital, National Defense Medical Center.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133338
- Sponsor's protocol ID
- TSGHIRB No. 1-103-05-122
- Status last verified
- Apr 2017
- First submitted
- 25 Apr 2017
- Last updated
- 2 May 2017
- 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 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Division of Traumatic and General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center
- ClinicalTrials.gov ID
- NCT03133338
- Acronym / sponsor ID
- TSGHIRB No. 1-103-05-122
- Conditions
- Pelvic Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 31 Jul 2014 (actual)
- Study completion
- 31 Jul 2014 (actual)
- First posted
- 28 Apr 2017 (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.
The investigators aimed to evaluate the effect of early pelvic binder use in emergency management of suspected pelvic trauma, compared with the conventional stepwise approach.
Detailed description
There is currently no universal consensus on all aspects of management of pelvic injuries.
Among patients with multiple injuries because of blunt trauma, 5%-16% sustain injuries to the pelvic ring, resulting in a mortality rate of 11%-54% primarily due to hemorrhagic shock. In theory, the reduction and stabilization of the pelvic ring can decrease bleeding from the fracture site, as reduction of pelvic volume has been shown to reduce the extent of hemorrhage from such injuries.The application of a pelvic binder has become part of the emergency care of all trauma patients with suspected pelvic fractures, in both the pre-hospital environment and emergency department (ED). The present study aimed to assess the effectiveness of the early use of pelvic binders to treat patients with a suspected high risk of pelvic bleeding from blunt force pelvic fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enrolled trauma patients with initial stabilization using a pelvic binder for suspecting pelvic injury. Inclusion criteria were traumatic injury requiring a trauma team and at least one of the following: loss of consciousness or Glasgow coma score (GCS) < 13; systolic blood pressure < 90 mmHg; falling from ≥6 m; injury to multiple vital organs; and suspected pelvic injury. Various parameters, including gender, age, mechanism of injury, GCS, mortality, hospital stay, initial vital sign, revised trauma score, injury severity score, and outcome, were assessed and compared with historical controls.
Key inclusion criteria (1 listed)
- Traumatic injury requiring a trauma team and at least one of the following: loss of consciousness or Glasgow coma score (GCS) < 13; systolic blood pressure < 90 mmHg; falling from ≥6 m; injury to multiple vital organs; and suspected pelvic injury. -
Key exclusion criteria (1 listed)
- Not meet the criteria and loss follow up (transfer to other hospital or data not available) -
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 |
|---|---|---|
| pelvic binderAlso: Angiography for TAEThe requirement of angioembolization can be predicted by the presence of intravenous contrast extravasation (ICE) on computed tomography (CT) | Device | – |
Primary outcome
Blood transfusion
Time frame: admission
Pelvic fracture with hemodynamic unstable
1 secondary outcome
admission mortality
Time frame: mortality in the same admission
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 2 May 2017.
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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.
Mu-Hsien Yu, Professor study director
Institutional Review Board II of the Tri-Service General Hospital, National Defense Medical Center.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fracture, run by Tri-Service General Hospital (TSGH).
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 1 inclusion and 1 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 2 May 2017. 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?
Blood transfusion (time frame: admission). 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 2 May 2017.