Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis

Study Overview
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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.

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.

Official Title
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Pre-hospital Advanced Therapies for Control of Hemorrhage (PATCH) - Pelvis

Conditions
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Hemorrhage, Pelvic Fracture

Intervention / Treatment
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* Device: Pelvic Binder


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic Binder<br>Commercially available device used to stabilize the pelvis | Device: Pelvic Binder<br> <br> |
| No Intervention: No Binder<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 48 hours |