Effect of Early Pelvic Binder Use in Emergency Management of Suspected Pelvic Trauma: a Retrospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Fracture
• Intervention / Treatment: Device: pelvic binder

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 Type: Observational
• Enrollment (Actual): 204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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. -

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood transfusion	Pelvic fracture with hemodynamic unstable	admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
admission mortality	mortality in the same admission	mortality in the same admission

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Study Director: Mu-Hsien Yu, Professor, Institutional Review Board II of the Tri-Service General Hospital, National Defense Medical Center.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): July 31, 2014
• Study Completion (Actual): July 31, 2014

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 2, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: TSGHIRB No. 1-103-05-122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No