Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis

Wake Forest University Health Sciences50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemorrhage Pelvic Fracture

Interventions

Pelvic BinderDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Carolinas Medical Center

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Mortality Rate

Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms

Time frame: 30 day

Secondary Outcomes

Pain Scores - Visual Analog Scale

Pain scores at presentation to hospital will be compared between the two study arms. Range 0-10. Higher scores indicate a worse outcome.

Time frame: At time of arrival to Emergency Department

Number of Participants With Skin Complications After Pelvic Binder Application

The rate of occurrence of skin complications after binder application will be documented.

Time frame: From date of randomization to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year

Length of Stay in Hospital

The total number of days the patient spent in the hospital

Time frame: From date of admission to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year

Number of Patients With Blood Transfusions

Number of Blood Transfusions within the first 48 hours after hospital admission

Time frame: 48 hours

Data from ClinicalTrials.gov

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