Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis

Not Applicable

Completed

• Conditions: Hemorrhage; Pelvic Fracture
• Interventions: Device: Pelvic Binder

• Registration Number: NCT02855060
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Primary Completion: 2018-06
• Study Completion: 2018-12
• Results First Submitted: 2020-01-07
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-30
• Results First Posted: 2021-08-02
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic Binder	Pelvic Binder	Commercially available device used to stabilize the pelvis

Primary Outcome Measures

Name	Time	Method
Mortality Rate	30 day	Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms

Secondary Outcome Measures

Name	Time	Method
Pain Scores - Visual Analog Scale	At time of arrival to Emergency Department	Pain scores at presentation to hospital will be compared between the two study arms. Range 0-10. Higher scores indicate a worse outcome.
Number of Participants With Skin Complications After Pelvic Binder Application	From date of randomization to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year	The rate of occurrence of skin complications after binder application will be documented.
Length of Stay in Hospital	From date of admission to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year	The total number of days the patient spent in the hospital
Number of Patients With Blood Transfusions	48 hours	Number of Blood Transfusions within the first 48 hours after hospital admission

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States