Pre-hospital Advanced Therapies for Control of Hemorrhage

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this study is to determine whether the use of pelvic binders in the ambulance setting improves outcomes including mortality in patients with pelvic fractures.

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Detailed Description

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The goal of this prospective, randomized clinical trial is to determine whether prehospital use of a commercial pelvic binder will improve morbidity and mortality in patients with pelvic fractures. We hypothesize that prehospital placement of pelvic binders will reduce hemorrhage and need for resuscitation and will improve overall mortality in patients with pelvic fractures. In addition, we hypothesize that pelvic splinting via external compression will improve patients' pain regardless of whether they have a pelvic, acetabular, or proximal femur fracture.

Conditions

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Hemorrhage Pelvic Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pelvic Binder

Commercially available device used to stabilize the pelvis

Group Type EXPERIMENTAL

Pelvic Binder

Intervention Type DEVICE

No Binder

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pelvic Binder

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Traumatic injury other than ground-level fall, and
* Complaint of pelvic groin or hip pain, or
* Pelvic or hip deformity, ecchymosis, or crepitus in an obtunded patient, or
* Hemodynamic instability

Exclusion Criteria

* Ground level fall
* Penetrating pelvis injury without frank evidence of fracture
* Obviously pregnant patients
* Patients who are too small or too big for the binder
* Priority 2 or 3 Trauma

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No