NCT03133338

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

April 25, 2017

Last Update Submit

April 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood transfusion

    Pelvic fracture with hemodynamic unstable

    admission

Secondary Outcomes (1)

  • admission mortality

    mortality in the same admission

Interventions

The requirement of angioembolization can be predicted by the presence of intravenous contrast extravasation (ICE) on computed tomography (CT)

Also known as: Angiography for TAE

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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. -

You may not qualify if:

  • Not meet the criteria and loss follow up (transfer to other hospital or data not available) -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip Fractures

Interventions

Angiography

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Cardiovascular

Study Officials

  • Mu-Hsien Yu, Professor

    Institutional Review Board II of the Tri-Service General Hospital, National Defense Medical Center.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Traumatic and General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center

Study Record Dates

First Submitted

April 25, 2017

First Posted

April 28, 2017

Study Start

August 1, 2013

Primary Completion

July 31, 2014

Study Completion

July 31, 2014

Last Updated

May 2, 2017

Record last verified: 2017-04